The Vaccine Adverse Event Reporting System (VAERS) Results

Covid19 Vaccines - Death

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VAERS data in CDC WONDER are updated every Friday. Hence, results for the same query can change from week to week.

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Vaccine

Symptoms

Age

Month Vaccinated

VAERS ID

	Adverse Event Description

	Current Illness

	Medications At Time Of Vaccination

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

18-29 years

Dec., 2020

Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive and subsequently expired at home on 1/11/21.

Whiplash injury to neck. Sprain of ligaments of cervical spine

See Continuation Field

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

30-39 years

Dec., 2020

Patient vaccinated on 12/28. Approximately one day later, develops cough and on azithromycin x 1 week. On 1/3, patient develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory failure secondary to COVID - on H&P. Patient died on 1/4/21 at 7:20am.

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

30-39 years

Dec., 2020

Found deceased, presumed while exercising

No current illness for this event.

Atorvastatin calcium 20mg daily

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

40-49 years

Dec., 2020

The patient was found deceased at home about 24 hours after immunization. Date of Death:: 12/29/2020; estimated time of death 6:00pm

No current illness for this event.

Hydrochlorthiazide (by record, not confirmed)

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

40-49 years

Dec., 2020

Notified by patient's sister on 1/26/2021 that patient died in his sleep on 1/25/2021. She did not know cause of death.

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

40-49 years

Jan., 2021

Pronounced dead 1/9/2021 at 12:42. Received first dose of vaccine 1/8/2021

Diabetes, Hypertension, Sleep Apnea, Obese

metform, atorvastin

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

40-49 years

Jan., 2021

possibly got it at clinic, possibly who administered shot. Pts. daughter said the pts boyfriend denied any symptoms the whole day but that in the middle of the night the pt passed away.

No current illness for this event.

Wellbutrin, Ambien

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Dec., 2020

syncopal episode - arrested - CPR - death

To be determined

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Dec., 2020

Found deceased in her home, unknown cause, 6 days after vaccine.

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Dec., 2020

Patient had been diagnosed with COVID-19 on Dec. 11th, 2020. Symptoms were thought to have started on 12/5/2020. Received Moderna vaccine on 12/23. Unexpected death on 1/8/2021. Resuscitation attempts unsuccessful

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Jan., 2021

Patient received COVID vaccination around 12:15pm. Patient was monitored for the appropriate amount of time by nursing staff. Patient passed away at 2:15pm.

None

Patient was refusing to take all medications for over a year

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Jan., 2021

Patient received the 1st dose of Moderna and was found deceased in her home the next day.

none known of

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Jan., 2021

Resident began having fever on 1/11/21 @0600. VS= T-102 B/P- 100/57 P- 112 RR- 24 O2 Sat 92% on RA. MD called. Rapid COVID Test was negative. CBC,CMP, U/A were ordered as well as CXR. Resident's condition declined. At 3:00pm resident started having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered. Condition worsened. Resident sent to nearest ER for evaluation. Later in the evening the staff AT Medical Center called to inform staff that resident had expired @ 2230 as a result of Respiratory Failure and Sepsis.

NONE

Haldol 2mg TWICE DAILY, DEPAKENE 750MG THREE TIMES

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Jan., 2021

51 year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became increasingly hypoxic around 1800hours 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at medical center.

Pulmonary fibrosis on O2

Alvesco inh, Mepron susp, Coreg, Zetia, Tricor, Umeclidinum, Cellcept, Zyprexa, Prilosec, paxil, Miralax, prednisone, trazodone, xopenex inh

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Jan., 2021

"""Moderna COVID-19 Vaccine EUA"" It has been reported to me that pt. had gone into hospital for a heart catheterization on 1/12/2021. It was found during this procedure that pt. had suffered a MI. She was release to home the following day and passed away at her residence on 1/15/2021."

Pt. stated she was not ill at the time of vaccination.

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Jan., 2021

Pt died 4 days after vaccine, no known reaction to the vaccination

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Jan., 2021

At 04:30 on 1/22/2021, facility was notified of employee death at home.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Jan., 2021

Pt deceased

N/A

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

50-59 years

Jan., 2021

per recipient spouse - vaccine recipient became ill during the night of 1/21/21 or early morning of 1/22/21 and was deceased in the morning of 1/22/21.

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Dec., 2020

1/1/2020: Residents was found unresponsive. Pronounced deceased at 6:02pm

- covid-19

- Invega Trenza 546mg Q3months - Lithium 300mg BID - Oxybutynin 5mg QID - lipitor 20mg QHS - cogentin 2mg BID - Norvasc 5mg QD - Dyazide Capsule 37.5-25 MG (Triamterene-HCTZ) QD

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Dec., 2020

Patient was vaccinated Dec 30, 2020. Prime dose of Moderna vaccine. Observed for full 15 minutes post-injection. No complaints when asked during observation. Released. Subsequently, vaccine clinic staff learned from the patient's supervisor that on Jan 4, 2021 that the patient had expired on Jan 2, 2021. By report from the supervisor, the patient was found dead at his home. The patient's primary care provider was unaware of his death when contacted by this reporter today (Jan 6, 2021). Electronic Medical Record without any information since the vaccination.

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Dec., 2020

Weakness, Low O2, death. Positive for COVID on 1/12/21, dies on 1/16/21

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

Notified today that he passed away. No other details known at this time.

unkown

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

patient reported expired 1/7/2021

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

This person was found to be deceased on routine rounds during the night, 3am. No symptoms of reaction noted post vaccine. No injection site reaction. No reports of any allergic reaction.

None

Amitiza, Anastrozole, Calcium Carbonate, Levemir, Novolog, Docusate, Fiber Lax, Fluvoxamine Maleate, Gavilax, Glucerna, Ketoconazole, levetiracetam, loratadine, Selenium sulfide lotion, vimpat, vitamin D3, Prolia AS needed medications: fle

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

Around 00:50am on 01/15/21, C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and started CPR. 911 arrived and pronounced resident dead at 1:01 am.

None

Ascorbic Acid Tablet 500 MG GT QD Multi-Vite Liquid (Multiple Vitamins-Minerals) 15 ml GT QD Famotidine Tablet 20 MG GT BID Memantine HCl Tablet 10 MG GT BID Polyethylene Glycol 3350 Kit 7gm GT QD Senna Tablet 8.6 MG (Sennosides) 2 tablets

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

"On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating ""I don't care."" repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T 99.4, Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21."

Non-Hodgkin Lymphoma, Rhabdomyolysis, Anemia, Acute Kidney Failure, Chronic Embolism and Thrombosis of Lower Extremity

Amlodipine, Aspirin, Atenolol, Chlorthalidone, Dexamethasone, Fluconazole, Multivitamin with Minerals, Probiotic, Acyclovir, Topiramate, Cefpodoxime, levetiracetam, Potassium, Acetaminophen, Aleve, Lisinopril

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

Resident expired 1/17/21

11/25/20 Lower mid back abscess 11/4/20 toenail removal

Diclofenac Sodium Gel 1 %, Atorvastatin Calcium Tablet 40 MG, Acetaminophen Tablet 325 MG, Melatonin Tablet 3 MG, Vitamin D3 Tablet 25 MCG, Iron Tablet 325, Multivital-M Tablet, Eliquis Tablet 5 MG, metFORMIN HCl Tablet 500 MG, NIFEdipine

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

No immediate reaction. Patient-reported deceased four days later on Jan. 19, 2021. As of this date cause of death is unknown to our clinic.

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

Patient deceased on 01/17/2021

TB DMII Hyperlipidemia GERD CKD Renal Failure

Asprin 81mg Calcium Acetate 667mg Ensure Plus Eucerin Furosemide 80mg Glipizide 5mg Omeprazole 20mg Renvela 800mg Rifampin 300mg Sensipar Vitamin D3

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

patient received the Moderna Covid 19 vaccine on 1/23/2021 around 5:45pm wife called management today and reported that he had collapsed and passed away today around noon

reported on profile were hypertension, pain, gout, bladder and urine flow issues

furosemide 40 mg indomethacin er 75 mg venlafaxine 75 mg tab hydralazine 50 mg metoprolol tart 100 mg verapamil er 240mg captopril 100 mg tamsulosin 0.4 mg oxybutynin er 15 mg pot cl micro er 20 meg spironolactone 25 mg gabapentin 300 mg

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

patient received covid vaccine and had a heart attack the next day and died

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

Resident was discovered deceased in his apartment on 1/23/2021. Family had

Patient had reported on 8/8/2019 having arthritis, leg wounds, COPD, asthma, incontinence of bladder. Resident may also have had blood clots in his legs, per his sister.

unknown medications for COPD, nebulizers, inhalers

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

death Narrative:

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

60-64 years

Jan., 2021

Pt likely presented to vaccine appt with asymptomatic/early infection of COVID-19, as he presented 2 days post-vaccination and tested positive for COVID-19 on rapid and PCR test. He was hospitalized where he eventually died of complications from COVID-19 while in ICU. Date of death was 1/15/2021.

Evaluated for L flank pain in ED on 1/1/2021, no acute findings on CT. Noted to be in mild CHF, discharged home from local ED.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 1920

DEATH- NO OTHER INFORMATION KNOWN

UNKNOWN

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2020

Two days post vaccine patient went into cardiac arrest and passed away.

NSTEMI, Dementia, TIA, COVID-19, HTN, CVA, PVD

Loratadine, Plavix, flomax, Lisinopril, atrovastatin, amlodipine, Pentoxifylline, ASA, Donepezil, trazodone, Metoprolol tartrate.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Patient had mild hypotension, decreased oral intake, somnolence starting 3 days after vaccination and death 5 days after administration. He did have advanced dementia and was hospice eligible based on history of aspiration pneumonia.

dementia declining oral intake

risperidone daily doxazosin

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

My grandmother died a few hours after receiving the moderna covid vaccine booster 1. While I don?t expect that the events are related, the treating hospital did not acknowledge this and I wanted to be sure a report was made.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Resident in our long term care facility who received first dose of Moderna COVID-19 Vaccine on 12/22/2020, only documented side effect was mild fatigue after receiving. She passed away on 12/27/2020 of natural causes per report. Has previously been in & out of hospice care, resided in nursing home for 9+ years, elderly with dementia. Due to proximity of vaccination we felt we should report the death, even though it is not believed to be related.

None

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Patient died within 12 hours of receiving the vaccine.

Refused food for one week prior to death.

Refused anything PO for about one week prior to death.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

After vaccination, patient tested positive for COVID-19. Patient was very ill and had numerous chronic health issues prior to vaccination. Facility had a number of patients who had already tested positive for COVID-19. Vaccination continued in an effort to prevent this patient from contracting the virus or to mitigate his risk. This was unsuccessful and patient died.

Yes

Quietapine, Mertazipine, Hydrocodone, Fentanyl

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

At the time of vaccination, there was an outbreak of residents who had already tested positive for COVID 19 at the nursing home where patient was a resident. About a week later, patient tested positive for COVID 19. She had a number of chronic, underlying health conditions. The vaccine did not have enough time to prevent COVID 19. There is no evidence that the vaccination caused patient's death. It simply didn't have time to save her life.

Patient was a resident of a long term care facility and had numerous chronic conditions prior to vaccination.

Torsemide, Trazadone, Amitizide, Morphine Sulfate, Fentanyl, Carbidoba-Levodopa, Prednisone, Potassium Chloride, Escalitapram, Incruse Ellipta, Mirtazipane, Clonazepam, Levothyroxine

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Prior to the administration of the COVID 19 vaccine, the nursing home had an outbreak of COVID-19. Patient was vaccinated and about a week later she tested positive for COVID-19. She had underlying thyroid and diabetes disease. She died as a result of COVID-19 and her underlying health conditions and not as a result of the vaccine.

Diabetes, Thyroid disease

Metoprolol-Tartrate, Latanoprost, Glipizide, Pravastatin, Metformin, Benaprezil, Potassium-Chloride, Levothyroxine

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Redness and warmth with edema to right side of neck and under chin. Resident was on Hospice services and expired on 1.1.21

G30.1 Alzheimer's disease with late onset (Primary) M19.90 Unspecified osteoarthritis, unspecified site J44.9 Chronic obstructive pulmonary disease, unspecified I95.1 Orthostatic hypotension J45.909 Unspecified asthma, uncomplicated R13.12 Dysphagia, oropharyngeal phase M15.0 Primary generalized (osteo)arthritis M85.80 Other specified disorders of bone density and structure, unspecified site Note: Osteopenia J30.9 Allergic rhinitis, unspecified F41.1 Generalized anxiety disorder M24.511 Contracture, right shoulder M24.512 Contracture, left shoulder M24.521 Contracture, right elbow R29.3 Abnormal posture M17.4 Other bilateral secondary osteoarthritis of knee M25.561 Pain in right knee R26.89 Other abnormalities of gait and mob

Cetirizine, Lactaid

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Resident had body aches, a low O2 sat and had chills starting on 12/30/20. He had stated that they had slightly improved. On 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again. He later went unresponsive and passed away.

Heart Failure

Fluticasone, Lasix, Omeprazole, Sucarafate, Ropinrole HCl

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

resident expired 1/1/2021

Low blood pressure requiring medication changes. Sent to ER on 1/1 with low b/p sent back same day, heart failure. Family requests comfort measures only.

Singulair, lopressor, pepcid, omeprazole, lasix, albuterol, azelastine eye gtts, calcium, eliquis, prozac, terazosin, magnesium oxide, potassium

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Resident expired 1/3/21

Covid positive previous with no s/s poor appetite Chronic wound right leg

aldactone, lasix, aspirin, tylenol, potassium, spiriva

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

PT was found deceased in his home on 1/5/2021

CHF HTN DM 2 CKD Obesity DDD

Norco 5/325 1 tablet every 6 hours as needed. Warfarin 4mg , 2 tablets orally Monday and Friday Torsemide 100mg, 1/2 tablet orally once a day Sabcubitril-Valsartan 24/26mg 1/4 tablet orally twice a day Gabapentin 300mg, tablet once daily Ca

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

No adverse effects noted after vaccination. Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back.

Digestive Surgery for bowel obstruction

Vit D3, Miralax, Spironolactone, Tramadol, Metoprolol Succinate, MOM, Ferrous Gluconate, Ondansetron, Nitroglycerin Sublingual PRN, PreserVision AREDS, Fluticasone Propionate Suspension, Lisinopril, Clopidogrel Bisulfate, Campor-Methol-Met

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

The resident resides in an independent living facility/apartment. The reporter at the center was informed by his daughter he was not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020 and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results, although the reporter indicates his daughter reports his test was positive.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Patient was reported to be deceased at home by law enforcement on 1/7/21

No acute illnesses

Oxybutynin Chloride, Lasix 80mg, hydyralazine 50mg, amlodipine 10mg, amitriptyline 10mg, ASA, Klor-Con 20meq, Tylenol, allopurinol 100mg, Vit D3, turmeric 400mg, Lipitor 80mg, gabapentin 100mg, baclofen 5mg, candesartan 32mg, insulin lispro

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

The facility had positive cases of COVID when we were able to begin vaccinating residents. Within about a week of vaccination, patient was tested positive for COVID. He was 91 years old and his immune system did not have the time to allow the vaccine to begin working before exposure. His age was a major contributing factor to his death.

Chronic pain

Mirtazapine, Fentanyl Patch,

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Resident received Moderna vaccine on 12/23/2020 around 5 pm. At approximately 3:35 am on 12/25/2020, resident had a CVA and died on 1/1/2021 at 3:00 am.

Anemia, cardiac murmur, atrial fibrillation, osteoporosis, dysphagia, hyperlipidemia, muscle weakness, aortic valve stenosis

Aspirin, Digoxin, Diltiazem CR, Namenda CR, Toprol XL, Acetaminophen, Vitamin D, Zyrtec

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death

no acute illnesses

Terazosin 5mg po HS, Metoprolol 12.5 mg BID, Depakote 375mg BID, Hydrochlorothiazide 12.5mg Q am

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

"Narrative: Patient with severe aphasia and only able to say ""hey, hey, hey"" or ""uh huh"" or shake his head no as a way to communicate. Patient previously able to ambulate with significant limp and hyperextension of right knee, but mostly wheelchair bound over last several years as he had had a slow and steady decline in overall health and mobility. Patient developed aggressive behavior of shouting ""hey"" and grabbing of groin in 2016. This was worked up with CT scans, labs, referral to urology, neurology, and referrals to psychiatry. The exact etiology of this action was never able to be affirmed, but thought to be more psychiatrically related. It improved significantly with addition of antipsychotics, worsened when antipsychotics were reduced, and improved again with addition of injectable antipsychotic on 12-10-2020.Patient suffered from falls on occasion given his significantly impaired physical mobility. His last documented fall was 8-31-2019. Patient began utilizing wheelchair most of time following that fall. No significant injuries noted in documentation of the falls. In the last 3 months, patient would often refuse medications. He would sometimes indicate that they would cause dizziness, and other times he would simply refuse. We attempted to hide medications in his food/fluid (with wife's blessing) and when he detected this he would occasionally refuse to eat. Patient previously on DOAC. After pharmacy review in 12/2020 it was recommended to discontinue this as no clear indication to continue use. He was high fall risk and would often refuse this medication as well since 10/2020. Noted to be in NSR on EKGs and decision made to discontinue the DOAC. Patient had no evidence of adverse effects noted after vaccination on December 28th. Patient seen by provider on the morning of his death (1/4/2021) with no noticeable significant change in health condition. Temperature 36.8Con January 4th at 19:45. During routine bedtime cares, patient suddenly collapsed and death was pronounced January 4, 2021 at 20:05. Autopsy was requested from next of kin and no autopsy was granted. Symptoms: & DEATH Treatment:"

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Patient was living in a nursing home with positive cases when administered. His age and chronic condition was such that he did not have time after the vaccination to avoid exposure or develop immunity.

No current illness for this event.

Atorvastatin, Ibuprofen, Oxybutinin, Morphine Sulfate

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

"Called to schedule second vaccine and daughter reports that he died on01/19/2021 with ""COVID"""

unknown

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

On the evening of 10JAN2021, patient experienced a low grade fever, decreased oxygen saturation of 38%, heart rate of 124, confusion. Patient received oxygen via face mask, morphine and ativan. By 11JAN2021, patient was no longer verbal, able to eat or communicate and was kept on comfort measure only. On the morning of 17JAN2021, the patient passed away.

COVID-19 positive on November 19, 2020 and didn't test negative until December 26, 2020

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Narrative: Symptoms: & DEATH DUE TO COVID 01/13/21 Treatment:

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Patient received Moderna COVID vaccine on 12/30/2020 at a Pharmacy clinic where he was a resident. Nurses at the facility reported that he was responsive and showed no signs of any adverse effects until 1/2/2021 when he was observed slightly unresponsive and staring at the ceiling and trembling. He had a fever of 101F at this time. The facility ordered labs and a rapid COVID test (all of which came back normal) and started IV antibiotics. A few hours later, patient began bleeding from his eyes, nose, and mouth and was sent to the local ER. The patient refused being admitted to the ICU for possible sepsis/hemorrhage and died the following day on 1/3/2021. All healthcare professionals involved agreed that this was not likely due to the vaccine, but needed to be reported nonetheless.

Unkown

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Patient passed away 23 days after receiving COVID vaccine

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Patient developed Covid pneumonia dx 1/15/21, patient expired

None

Lasix 20 mg daily, KCL ER 20 MEQ daily, Eliquis 2.5 mg twice daily, allopurinol 300 mg daily, Lyrica 50 mg daily, Metoprolol Succinate ER 50 mg daily, Amlodipine 5 mg daily, Pravstatin 20mg daily, Vit d3 25mcg daily

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Not sure if it has to do with the COVID vaccine but her caregiver reported to me today (1/27/20201) that she passed away on 01/16/2021 from a pulmonary embolism that was 18 days after vaccine

none per care giver

none as far as i know

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

patient received COVID vaccine on 12/29/2020 and passed away on 1/23/2021

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Pt. was admitted to hospital on 1/6/21 with fatigue, weakness. Pt. was Covid positive in November of 2020. Impression upon admission was fatigue may be due to her aortic stenosis and some hypertensive issues with blood pressure changes. She was anemic. WBC was elevated to 19.2, HBG 10.5, NA-131, K+ - 3.1, Rule out bacterial infection. Potential source could be her heart valve. Also noted to have acute renal failure with BUN of 47 and Creatinine of 2.2 noted. Pt. was transferred to Hospital on 1/8/2021 with dx of aortic stenosis, bacteremia, ARF, Dehydration and anemia. Discharged with dx. of sepsis. Pt. expired on 1/18/21 with dx. of severe sepsis, complete heart block, staphylococcus epidermidis bacteremia.

Denied any illness at time of the vaccination. November 2020 was diagnosed with Covid-19. Admitted to Hospital on 01/6/2021 with c/o weakness. Reported that her weakness was over her entire body. Reports having episodes of vomiting once or twice a week.

Bystolic - started on 12/21/20, Crestor started on 11/09/2020, Qzemoic subq weekly, Advair diskus, Fish oil, ASA, Vitamin E, Multivitamin

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Dec., 2020

Death Narrative: Patient had Parkinson's and advanced Dementia. He was on a palliative care unit and a DNR.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

DEATH ON 1/4/2021, RESIDENT RECIEVED VACCINE ON 1/2/20

CEREBRAL INFARCTION, UNSPECIFIED(I63.9), LONG TERM (CURRENT) USE OF ASPIRIN(Z79.82), VITAMIN DEFICIENCY, UNSPECIFIED(E56.9), ACUTE KIDNEY FAILURE, UNSPECIFIED(N17.9), HYPERKALEMIA(E87.5), ACUTE RESPIRATORY FAILURE, UNSPECIFIED WHETHER WITH HYPOXIA OR HYPERCAPNIA(J96.00), PURE HYPERCHOLESTEROLEMIA, UNSPECIFIED(E78.00), PAIN IN RIGHT FOOT(M79.671), ESSENTIAL (PRIMARY) HYPERTENSION(I10), ACIDOSIS(E87.2), ABNORMAL LEVELS OF OTHER SERUM ENZYMES(R74.8), HYPERLIPIDEMIA, UNSPECIFIED(E78.5), DISORDER OF THYROID, UNSPECIFIED(E07.9), GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS(K21.9), MUSCLE WASTING AND ATROPHY, NOT ELSEWHERE CLASSIFIED, UNSPECIFIED SITE(M62.50), MUSCLE WASTING AND ATROPHY, NOT ELSEWHERE CLASSIFIED, MULTIPLE SITES(M62.59), CO

Acetaminophen Tablet 325 MG Give 2 tablet by mouth every 6 hours as needed for Pain. elevated Temp. Phone Active 05/08/2020 05/08/2020 AmLODIPine Besylate Tablet 10 MG Give 1 tablet by mouth one time a day related to ESSENTIAL (PRIMARY) HYP

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

At approximately, 1855, I was alerted by caregiver, resident was not responding. Per caregiver, she was doing her rounds and found resident in bed, unresponsive, mouth open, observed gurgling noises and tongue hanging out of mouth. This primary caregiver observed resident at baseline and ambulating after dinner at approximately, 1800 less than an hour prior to incident. This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department. At ER, CT scan and X-ray was performed. Per report from ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per RN, resident was still unresponsive and was admitted to Medical Center for observation and comfort measures. This primary caregiver reported to RN, resident recently received the first dose of COVID-19 vaccine on 1/2/21. Primary caregiver received a call from Castle RN at 0700, resident expired at 0615.

none

Metoprolol succ ER 50mg 1 tab PO daily Omeprazole DR 20mg 1 cap PO daily Amlodipine besylate 5mg 1 tab PO daily Aspirin 81mg 1 tab PO daily Carbamazepine ER 100mg 1 tab PO TID Docusate 100mg 1 cap PO daily Multivitamin 1 tab PO daily Olmesa

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Deceased

NONE

Avorstatin Aspirin Oxycodone

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient did not report any signs or symptoms of adverse reaction to vaccine. Patient suffered from several comorbidities (diabetes and renal insufficiency). Patient reported not feeling well 01/06/2021 and passed away that day.

Diabetes, renal insufficiency

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Resident passed away in her sleep

Atrial fibrillation, Anemia, 1st degree AV block, CDK stage 4,

Amiodarone Hcl, Carvedilol, Ferrous sulfate, Eliquis (cont)

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient received vaccine on 1/4/2021. He was in Hospice for CHF and renal failure, but was able to get up in his wheelchair and eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow. No localizing neurologic findings. He was too lethargic to get up in chair.

none acute

Amlodipine 5 mg daily, Dexamethasone 4 mg daily (for itching related to renal failure), Isosorbide dinitrate 30 mg daily, Levothyroxine 0.075 mg daily, Bisoprolol 5 mg BID, Furosemide 80 mg BID, saline nasal spray, Tylenol 1000 mg PO TID

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

"1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021 Complained Right arm hurt, dizzy 1-4-2021 Felt better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was ""cardiac event"" according to death certificate."

MACULAR DEGENERATION 10 YEARS OR MORE

NONE

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Staff reported that patient was found Friday morning (Jan 8) sitting at a table with his head tilted forward and unresponsive to verbal or physical stimuli. Staff lowered patient to floor and started CPR. EMS was called and continued CPR at scene, however they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of patient show that he had a fall about 1 hr. prior. It is unknown if this fall contributed to patient's death. An autopsy has been requested.

No Acute Illnesses

Patient was a resident in Group Home Current Medications Treatments/PRN Medications: Start Date: 04/02/14: Benztropine 2mg tab BID (8-8) 02/27/15: Midodrine (Proamatine) 5mg tab TID (8-12-8) 12/30/15: Cetirizine 10mg tab daily @8am 1

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient received COVID-19 (Moderna) vaccine from the Health Department on afternoon of January 8, 2021 and went to sleep approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January 9, 2021

Cellulitis of left lower limb (12/2020)

Singulair, Oxybutynin, Fosamax, Prednisone, Meloxicam, Eliquis, Bumetanide, Triamcinolone cream, Klor-Con, Lisinopril, Promethazine,

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Pt expired due to possible cardiac arrest. Unsure if this was vaccine related.

None known

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

"Patient received vaccine on 1/8/2021. On 1/9/2021 I checked on patient via phone for symptoms or problems and he reported none but mild soreness at injection site. On 1/10/2021 family friend called me to tell me that patient had expired at about 8:00 pm. Patient reportedly complained of ""pain"" unspecific and collapsed at home. Hospital reportedly told family that it appeared to be a ""heart attack""."

None reported

see attached

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient received her vaccination on 1/12/21 administered by pharmacy*+. She expired on 1/12/21 an approximately 7:30pm. Resident did not have any adverse reactions and was a hospice patient.

Resident was a hospice patient but POA requested that she get the vaccination. Resident was already near end of life and the vaccine may not have had anything to do with her death.

LORazepam Solution 2 MG/ML

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

"Patient was found ""acting abnormal"" on 1/9/2021 at 1215. VS HR 20-30's. EMS activated. EMS arrived and patient was found pulseless in PEA/ asystole, CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and expired on 1/09/2021 at 1348. Clinical impression Cardiopulmonary arrest."

None

Amlodipine, ASA, Atorvastatin, Baclofen, Risperidone, Levothyr

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to use his left side. Resident passed away on 1/11/2020.

Resident was on hospice for Alzheimer's disease.

Escitalopram Oxalate, Metformin ER, Systane balance, Colace, Refresh tears, Milk of Magnesia, Diltiazem

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

The patient passed away today, 1/13/2021. She was a hospice patient. She showed no adverse effects after receiving the vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went limp and was non-responsive. The patient passed away at 7:45 am.

N/A

Tylenol 325mg, Lasix 20mg, Senna 8.6mg, Aspirin 81mg, Levothyroxine 75mcg

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Pt collapsed at home approx 5:30 pm and died

none known

unknown none reported

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

No adverse reactions observed after administration of medication. Patient starting complaining of shortness of breath around 0500 the following morning. SP02 checked in the 80s. Patient expired 01/09/2021;

Rigth femur fracture, GI bleed

Alvesco, Amiodarone, Lipitor, Atrovent, Coreg, Cymbalta, Guaifenesin, Keppra, Levothroid, Megace, Protonix, Potassium, Prednisone, Rifampin, Carafate, Bactrim, Flomax

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient died on 1/21-2021

CAD, angina, coronary bypass in 1990's, Cardiac Cath on 12/28/2020

Atorvastatin 80mg daily, biotin 2500mg daily, Calcium-Mag-Zinc tab daily, Restasis eye drop q12hr, ezetimibe 10mg qhs, gabapentin 100mg bid, lysine 1000mg daily, metoprolol tart 50mg bid, fish oil 1000mg daily, prilosec 20mg daily, ranola

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient had no immediate effects from the vaccine, but died approximately 8 hours after receiving first dose of vaccine.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

We got a call from a home health nurse Brandu Talamo, stating that the patient passed away.

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Resident had lunch on 01/14/21 and after lunch around 2:00pm, he vomited and stopped breathing. We coded the resident and 911 paramedics came. They pronounced him dead at 2:18pm.

None but he has History of COVID-19 previously when initially admitted to the facility.

Melatonin 3mg PO QHS Amlopidine Besylate 5mg PO QD Atorvastin Calcium 20mg PO QHS Carbidopa-Levodopa 25-100mg PO TID Multiple Vitamin 1 PO QD Senna 8.6mg PO BID Calcium-Vitamin D 600mg PO BID Metformin HCl 500mg PO BID Rivastigmine patch 9

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

This patient has been under hospice care for over 2 years at the nursing home. She has had a steady decline with gradual weight loss. She was totally dependent in her care needs. She received the vaccine on 1/2/2021 as part of the facility vaccination campaign. No adverse events noted initially. On 1/3/2021 at 6:06 pm, she was noted on vital sign checks (done every 4 hours for first 72 hours after vaccination) with BP 64/52 but otherwise asymptomatic. Subsequent BP improved. On 1/4/2021 at 4:45 am, pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5 mg without improvement. Supplemental oxygen was applied. Tachypnea persisted. She had poor oral intake after that point had persistent tachypnea and worsening hypoxemia despite clear lungs on exam. She remained under hospice care and comfort measures were continued. No blood testing or imaging tests were done. She required increasing amounts of oxygen, became hypotensive, and died peacefully on 1/8/2021 at 7:45 pm.

Redness to left foot about 1 week prior to vaccination that resolved a few days prior

Senna-S, cranberry pills

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Headache after dose was given at 10:00 a.m Died at after 7:30 pm the same night the dose was given.

No current illness for this event.

allopurinol -Zyoprim 3000 mg amlodipine Norvasc 5 mg Lispro 100/unit /ml ups us to 150 unit daily per insulin scale Levemir U-100 - 100/unit/ml - (3ML) 55 units nightly Levothryoxine -Synthroid - 137 mcg - daily Simvastatin 25 mg - d

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Resident was seen by MD on 1/11/2021 due to increasing in edema and shortness of breath. Lasix 40 mg STAT given. New orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on oxygen. He was assisted to the toilet on 1/15/2021 in the morning where he subsequently passed away.

Edema, Hypokalemia, Hypertensive heart with heart failure

Lasix, Timolol Maleate, Benefiber, Pravastatin, Multivitamin, Carbidopa ER 50-Levodopa 200 daily; Carbidopa ER 50-Levodopa 200 2 tabs daily, I-vite, Lactobacillus; Metoprolol Succinate; Tamsulosin, Finasteride, Oxubytynin

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient presented to our Emergency Department via EMS in full code status; asystole. Patient expired. Per nursing, husband stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went unresponsive and husband called EMS.

none known

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Death

None

No scheduled medications Tylenol and Zyrtec as needed

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

patient started to decline 1/10/2021, patient seen at facility by medical professional - patient deceased 1/13/2021

COVID-19, ARDS, enterocolitis, Sepsis, UTI, Acute renal failure

Seroquel, ibandronate, atenolol, Lexapro, simvastatin, acetaminophen, estradiol, famotidine, calcium citrate, antacid, donepezil, ferrous sulfate, Probiotic Pearls Complete, memantine, Antifungal cream, potassium chloride, Creon, bisacodyl

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

On 1/13/2021, resident had sudden emesis. Immediately following emesis he was noted without a pulse and pronounced deceased. No acute symptoms noted prior to this episode. Resident does have a significant cardiac history.

None

Norvasc 10mg daily Multivitamin daily Vitamin C 500mg twice daily Folic Acid 1mg daily Aspirin 81mg daily Thiamine 100mg daily Coreg 6.25mg twice daily Ativan 0.5mg three time daily Cymbalta 30mg daily ProStat 30ml three time daily D

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

resident had a pressure ulcer to RT hip, was getting treatment on. Was scheduled to have wound debrided and wound vac applied on 1-19-2021. Appetite was poor, not wanting to get out of bed, and decline in alertness. Passed away on 1-16-2021

pressure ulcer

amlodipine, aricept, bactrim, namenda, remeron

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient died 1 week after vaccination. According to family was having very rapid decline in status in recent weeks and they did not think related to vaccination.

recently diagnosed with progressive supranuclear palsy

alfuzosin, allopurinol. amlodipine, aspirin, Sinemet, vitamin D, multivitamin, Lexapro, finasteride, mirtazipine, ropinirole, trospium

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Resident was noted unresponsive, no respiration, no blood pressure, no pulse, code blue called according to facility protocol, resident is full code, CPR started, 911 called, arrived and took over from staff. Resident was pronounced dead at 1:16pm 1/18/21

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Presented to Urgent Care for weakness and confusion, transferred to ED, patient had a cardiac arrest and was unable to be resuscitated

No current illness for this event.

sotaloL (BETAPACE) 80 mg Tablet omeprazole (PRILOSEC) 20 mg Capsule, Delayed Release(E.C.) sevelamer carbonate (RENVELA) 800 mg Tablet polyethylene glycol 3350 (MIRALAX PO) acetaminophen (TYLENOL EXTRA STRENGTH PO) fluticasone propionate (F

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient has end stage renal disease and rapidly worsening dementia, family could no longer care for him at home, and he was admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138 CREAT 6.93 K 5.2 were his baseline. He was found to be deceased on 1/18 at 11:18 pm.

none other than chronic conditions as listed under item 12.

1) AMLODIPINE BESYLATE TAB 5MG PO QPM ACTIVE 2) ASPIRIN (OTC) TAB,CHEWABLE 81MG PO QDAILY ACTIVE 3) CARVEDILOL TAB 12.5MG PO BID ACTIVE 4) CHOLECALCIFEROL (VIT D3) 25MCG=100

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Clients wife reported on 1/18/2021, that her husband died unexpectedly the day after receiving the COVID 19 vaccine. I called and spoke with her. She stated that the client had started experienced some tightness in his chest the evening of 1/11/2021. She stated that it was normal for him to have the tightness in his chest if he got stressed. She stated that she found him on the garage floor on 1/12/2021 at 2120. He was taken by ambulance to the hospital. She stated that the hospital told her that his COPD had caused him to go into arrythmia.

lung infection treated with antibiotics a couple of weeks ago

Albuterol nebulizer, Saline nebulizer, Metoprolol, Vespi, Albuterol Inhaler, antibiotic 2-3 times per week

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient received COVID 19 vaccine 01/14/2021. Patient died in his sleep 01/16/2021.

No current illness for this event.

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient died 4 days after immunization. Probably unrelated to immunization, as patient has been in poor health and was receiving hospice services. I have no details related to his illness or symptoms. Daughter is the HIPAA/emergency contact and will have all the information needed.

uncertain illness, however, patient was on Hospice.

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Pt passed away the day after the vaccine was given.

n/a

N/A not a resident at the living center.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at approximately 12pm. She completed all necessary screening forms and was deemed to be at low risk for serious allergic reactions. She tolerated the vaccination well, and no complications or immediate adverse events occurred. She was observed for a full 15 mins per CDPHE/CDC guidelines and left the Clinic in stable condition after her observation period was complete. On the morning of Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by Ambulance to Hospital shortly thereafter. She was diagnosed with a brain bleed that was determined to be inoperable. She was transferred to other Hospital for higher level care. She was seen by neurosurgery and diagnosed with a ruptured aneurysm. She was treated in the ICU for 24 hours, at which point her team determined that the severity of her brain bleed would not respond to treatment. Supportive cares were withdrawn on Wednesday Jan 20th, and she passed away shortly thereafter.

None disclosed

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Narrative:

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Pt received second dose of COVID vaccine on 01/20/2021 at 1430. At 1600 Pt developed a wet productive cough with coarse crackles. Pt ate dinner at 5 pm cough persisted. At 18:30 the nurse went to Pt's room to give him his medications. Pt still had a cough, denied shortness of breath. Pt was in a good mood and joking with staff. Pt asked to be shaved. At 19:45 Pt was sitting in the lounge and a CNA noticed that Pt was pale/white in color and clammy. 02 Sat was 85%. Respirations were labored. Pt was placed on 4 L of 02. Increased to 5 L via face mask and 02 sat was 89-90%. Ambulance was called at unknown time. Pt arrived at Medical Center at 2120 and was pronounced dead at 2127.

Unknown

Acetaminophen, Digoxin, Insulin glargine, Loratadine, Simvastatin, Tamsulosin, Warfarin

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

unknown. Event occurred after leaving vaccination site

denied ill symtpoms at time of vaccination

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Narrative:

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Narrative: Symptoms: & Cardiac Arrest; Death Treatment: EPINEPHRINE

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient diagnosed with COVID on January 9, 2021 after being exposed to family member that was under quarantine in the same household. Admitted to the hospital and was discharged on January 14, 2021 with home hospice. Patient passed away on January 18, 2021

No current illness for this event.

Klonipin, Myrbetriq, Zoloft, Carafate, Isosorbide, Allopurinol, Colace, Calcium Carbonate, Synthroid, Famotidine, Metoprolol, Losartan, Tylenol

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient passed away on 01/18/2021

No current illness for this event.

Lisinopril, Januvia, Fosamax, Trazodone, Metoprolol, Colace Simvastatin, Levoxyl, Lantus, Zocor

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient died unexpectedly 5 days after receiving vaccine (1/10/2021).

No known illnesses at time of vaccination.

Albuterol, Aspirin, Ativan, Ayr Saline Nasal, Biotene Dry mouth moisturizing spray, docusate sodium, Florajen 3, gabapentin, hydralazine HCL, Hydrocortisone acetate/LI, Isosource VHN 1.5 cal, ketoconazole, Lasix, lopressor, multivitamin, pl

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient began with a wet productive cough with crackles heard at 4 pm, at 5pm he went to dinner and still had cough, at 630 was administered his medications and he had cough, no shortness of breath and was in a good mood. By 7:45pm CNA found him in the lounge with labored breathing, 02 was at 85%. They gave him 4 liters o2, then a facemask at 5 liters which brought his o2 into the 90's. At that time called ambulance, patient arrived to ER around 9:20pm and passed away shortly after. Cardiac Arrest

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

1/13/21 pt came into clinic for vaccine. Had difficulty remembering age. Called me Mon. 1/18/21 stating she was sick. When asked what her sx were, she stated fatigue. She was well the night of the shot, Thur. and Fri. but became tired on Sat. and Sun. I went through other sx with her such as h/a, fever, n/v, muscle aches, weakness and she said she experienced none of those. I questioned her about eating and drinking and she said she ate and drank water. She seemed fine so I told her to call her doctor if she was worse or the fatigue persisted or call 911. She agreed. Two staff from clinic called her Mon. and Tues, (1/18 and 1/19). On Tues. she may have had sl slurred speech. She was found deceased on

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

began itching within 24 hours, within 5 days couldn't move on her own, by 6th day was having respiratory issues, by day 7 unresponsive, by day 8 dead

nose bleeds

metoprolol, methotrexate, calcitrol, digoxin, calcium prednisone, clopidogrel, levothyroxine, folic acid, pantoprazole, eliquis, atorvastatin, latanoprost, melatonin

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient received her first dose of vaccine on Monday, January 18th. Two days later on Wednesday, January 18th, she retired to bed early. Later that night when her husband went to bed, he found her in the bed deceased. No other details of the event are know.

Emergency Room Visit 1/7/2021 complaining of shortness of breath and swelling. She and elevated D-dimer with no evidence of a Pulmonary Embolus. Persantine Myoview showed small mild area of reversible ischemia to the inferolateral apical wall. Mild symptoms of vague discomfort in her chest, but nothing that has been reproducible with activity. She is chronically short of breath with limited activities because of problems with her hip

Albuterol Sulfate HFA 108 MCG/ACT AERS Allopurinol 300 MG Oral Tablet Aspirin Low Dose 81 MG TABS Baclofen 10 MG Oral Tablet Bystolic 10 MG Oral Tablet Clobetasol Propionate 0.05 % External Cream Cyanocobalamin 1000 MCG TABS Fish Oil

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

We were alerted that the patient died at home.

pt denied

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Headache, pain in the injection site, threw up. A few hours later she died.

Diabetes, hyper tension

Levothyroxine, Gabapentina, furosemide, Losartan, pravastatin

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

"Patient is reported to have died at home, the day after his COVID test. Family member states that he did good the afternoon and evening after his COVID-19 injection, but that he started not feeling good the next day. The patient ""was having palpitations"". The family tried to convince him to go to the Emergency Room, but he refused. Patient died at home."

DM II

Unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Died within 5 days of receiving vaccine. Exact cause and day unknown.

No current illness for this event.

Ketoconazole, lisinoprol, atravastatin, xarelto, bupropion, sertraline

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Pt passed away evening of 1/13 - unknown reason currently Narrative:

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

My dad got the Moderna Vaccine on Tuesday, January 12, 2021 in his left arm at the Mall injection site for the Health Department. He was told that the side effects could mean his arm hurting, tiredness, headache, and even a low grade fever. Additionally, the site informed us both (as I was with him to get the injection) that this was all normal and not to seek medical attention unless these symptoms last longer than 72 hours. That evening, my dad was experiencing all of those symptoms, and went to bed at 7pm. A little after 10am on Wednesday, January 13, 2021, when he awoke, my dad went to the bathroom vomiting. This was where he collapsed and went into cardiac arrest. Fire/Rescue was dispatched about 10:30am after my mom started CPR. County Fire Rescue EMTs and Paramedics continued CPR and other attempts at reviving him all the way to Hospital Emergency Department. He was pronounced dead at 12:14pm on Wednesday, January 13, 2021. We have no doubt my dad, following the instructions of the injection facility, thought he was just experiencing the side effects of the vaccine. He had no chance. Had this injection been done in the RIGHT arm, perhaps he could have recognized the arm numbness being that of an impending heart attack. We really miss Dad. He served this country with distinction for over 50 years, and we believe his country failed him.

None known

I do not have that information at the time of this filing. I?m his Son making the filing

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

My mother died 12 hours after the vaccine was administered

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient obtained initial dose of Moderna vaccine on Thurday, Jan 14. No adverse effects reported during initial 15 minute post vaccine waiting period. Saturday morning (Jan 16), patient developed severe cough, labored breathing, and fever. Additionally patient mental status changed suddenly, became non-communicative (unable to speak, but would scream if she was touched). O2 status was irregular, dropping to 78. Sunday morning, EMT and then hospice was hospice called. Monday morning, after hospice emergency kit was initiated, patient passed away.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Found dead at home slumped on the floor; Loss of appetite; Body aches; Feverish; A spontaneous report was received from a physician, concerning a 65-years-old male patient, who received Moderna's COVID-19 Vaccine and experienced feverish, body aches, loss of appetite, and death. The patient's medical history, as provided by the reporter, included diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia. Concomitant medications reported included metformin, glimepiride, lisinopril, atorvastatin, aspirin, methimazole, propranolol, and cilostazol. On 05 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 037k20a) for COVID-19 infection prophylaxis. On an unknown date in Jan 2021, some time after receiving the vaccine, the patient was feeling feverish with body aches and loss of appetite. On 09 Jan 2021 at approximately 21:30, the patient was found dead at home slumped on the floor. According to the paramedics, the patient was dead longer than when his wife found him, and no resuscitation was performed. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, feverish, body aches, loss of appetite, was considered resolved. The patient died on 09 Jan 2021. The cause of death was not reported. The reporter assessed the event, death, as not related to Moderna's COVID-19 Vaccine. The reporter did not provide assessment for the events, feverish and body aches, in relation to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 65 year old male patient with medical history of diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia, who experienced the serious unexpected event of death, non-serious unexpected event of loss of appetite, and non-serious expected events of fever and body pain. The event of death occurred 5 days after the first dose of mRNA-1273. The events of fever, body pain and loss of appetite occurred an unspecified period of time after the first dose of mRNA-1273. Very limited information regarding these events has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Definitive causal association is confounded by age and medical history of diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia.

No current illness for this event.

METFORMIN; GLIMEPIRIDE; LISINOPRIL; ATORVASTATIN; ASPIRIN (E.C.); METHIMAZOLE; PROPRANOLOL; CILOSTAZOL

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient died.

Metastatic duodenal adenocarcinoma , bladder cancer, undergoing chemotherapy with success. Dual chamber pacemaker

Creon 36K -114K Doxycycline Hyciate 100 MG Eliquis 5 mg Furosemide 40 mg Losartan Potassium Pantoprazole Sodium 40 MG Sildenafil Citrate 100 MG Stendra 200 MG Tadalafil 20 MG Tramadol Hcl 50 MG Trazodone Hcl 100 MG Triamcinolone Acetonide

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed.

High blood pressure. Dialysis

thiamine 100 MG tablet sevelamer carbonate 800 MG tablet Multiple Vitamins-Minerals (MULTIVITAMIN ADULT) Tab carvedilol 3.125 MG tablet ascorbic acid 500 MG tablet lisinopril 10 MG tablet

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Pt developed COVID-19 infection, symptoms starting 7 days after first dose was given. Patient was admitted to hospital on 1/21 after falling (secondary to weakness) and striking head on toilet. Patient expired due to respiratory complications of COVID on 1/25.

I-caps

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

"Pt. woke up the next morning after vaccination and ""didn't feel well"", described by wife as fatigue, no energy. At approximately 2 PM, he vomited. His wife checked on him at 4:20 PM and he wasn't breathing sitting in his chair. EMS squad was called but when they arrived he was asystole and mottling present. Did not start CPR since he was already gone too long. Pronounced by coroner on scene."

last doctor visit on 10/27/2020 and no illness at that time, routine follow up

atorvastatin 10 mg avodart 0.5 mg finasteride 5 mg colace 100 mg fish oil capsule over the counter nabumetone 750 mg omiprazole 20 mg tamsulosin 0.4 mg calcium plus D3 over the counter

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

patient received vaccine on 1/20/2121, later that night husband found her slumped in chair, called EMS and patient was taken to Hospital where she died on 1/21/2021

A fib, type 2 diabetes, HTN, seizure disorder, CHF

not known

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Resident became lethargic and reports of blood coming from resident's nose and mouth on the morning of 1/13/21. Resident went out to ER for eval, and came back to facility with dx of pneumonia and recommendations for resident to be placed on hospice. Resident deceased on 1/14/21. Unknown if vaccine related, but with timeline of events I was advised to report this per medical director of facility, as well as Pharmacy who administered the vaccine.

Resident was Dx with pneumonia the day after vaccine.

Pantoprzole, Miralax, Potassium, buspirone, Aspirin 81mg, Atenolol, Depakote, Glucosamine-chondroitin, mirabegron ER, Zyprexa, Atorvastatin, Ocuviteeye&MVM

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Died about 24 hours later

Unknown

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

"Patient was tested positive for Covid-19 on 12/9/20. Patient received Covid Vaccine on 1/21/21. Patient was observing for 15 minutes in treatment room by Nursing staff. Patient denied any signs/symptoms adverse effect: headache, dizziness & weakness, difficulty breathing, muscle pain, chills, nausea and vomiting, and fever . Patient seated on treatment table appeared to be relaxed, respiration even and unlabored. Health teaching provided. Patient educated to report any changes in condition to staff immediately. Patient verbalized understanding and able to verbalize signs and symptoms and adverse effects to be aware of related vaccine. On 1/22/21: patient was seen by medical provider for ""altered behavior"". Per medical provider's documentation: ""Patient was fallen on 1/2/21 and was sent out to outside hospital on 1/4/21. CT head: no intracranial abnormality, age-related changes. Patient had labs (B12, RPR, folate) were within normal limit"". We did MMSE today: 22/30 score ""mild dementia"" On 1/23/20: ""Patient was inside his cell. He was walking towards cell door to obtain his breakfast, when custody witnessed him collapse and activated the alarm. Nursing staff arrived at cell front at 06:34 am and found the patient pulseless and unresponsive, and CPR was immediately initiated. AED was attached at 06:35 am and no shock advised. AMR then arrived and patient did not have ROSC, and was pronounced dead at 06:54 am."""

Fall on 1/2/2021

Aspirin EC 81mg, Atorvastatin 10mg, Glipizide 5mg, Lisinopril 40mg, Metoprolol tartrate 25mg, Latanoprost, Sertraline 25mg, Paliperidone 324mg q28 days, Acetaminophen 325mg, Naproxen 500mg, Capsaicin 0.025%, Glucose 40%, Naloxone Nasal Sp

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

DEATH Narrative:

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Resident deceased on 1/26 at 445am. No signs ahead of time.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

ON 1/21/2020 RESIDENT WAS EXPERINCING CHILLS AND LOOSE STOOLS. FOLLOWING THIS EPISODE BECAME UNRESPONSIVE, PALE, DIAPHORETIC AND BRADYCARDIC. PALLIATIVE CARE WAS PROVIDED. RESIDENT PASSED AWAY APPROX. 10 HOURS LATER.

URINARY TRACT INFECTION

SYNTHROID 25MCG DAILY PRILOSEC 10MG DAILY CASODEX 50MG DAILY TYLENOL 500MG THREE TIMES DAILY MULTIVITAMIN DAILY ZOLOFT 25MG DAILY NAPROXEN 440MG DAILY

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill feeling, no fever, cleared for vaccination. Is chronically SOB due to COPD, but patient reported no different than usual. Presented to the ED the next day c/o SOB and weakness for the last week. Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID). Patient did admit she lied about her symptoms on the day of vaccination to get the shot.

Pneumonia, pleural effusion, COPD,

albuterol, amlopidine, aspirin, atorvastatin, lasix, gabapentin, HCTZ, hydroxyzine, lansoprazole, levalbuterol, losartan, meloxicam, Norco, Nystatin, Preservision, Prolia, Refresh eye drops, Spiriva, Wixela

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

on 1/13/2021 at 3:40am Cliff called for assistance. He lost his balance and had fallen. Cliff refused vitals, refused emergency department, denied hitting his head. As the day progressed patient developed a headache, diarrhea, and vomiting. He again declined the offer for the emergency room. At supper time wife and staff found Cliff unresponsive, 911 was called and he was taken to the emergency department. The ER did a CT scan and found an acute subdural hematoma. Patient was placed on comfort cares and expired at 3pm on 01/14/2021. Cliff did not have a history of falls.

Stable

Cholecalciferol 1000 ius daily, Magnesium Oxide 400mg BID, Vi

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01).

No current illness for this event.

ATORVASTATIN 20MG DAILY, GABAPENTIN 300MG TWICE DAILY, HYDRALAZINE 10MG 3 TIMES DAILY, LANTUS 30UNITS AT BEDTIME, LUMIGAN OPHTHALMIC SOLN BOTH EYES EVERY EVENING, METOLAZONE 2.5MG DAILY, OMPERAZOLE 20MG DAILY, PREDNISONE 15MG DAILY, TORSEMI

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Resident vaccinated on 01/06/21 she acquired COVID 19 on 01/10/2021. Resident had multiple co morbidities and was declining prior to the vaccine. Resident expired on 01/20/2021

COVID 19 01/10/2021 HYPEROSMOLOTY AND HYPERNATREMIA HERNIA HYPERGLYCEMIA LOW BACK PAIN ANEMIA OSTEOPOROSIS DEMENTIA WITH BEHAVIORS CONSTIPATION CARDIAC MURMUR/HEART DISEASE POLYNEUROPATHY HX OF BREAST CANCER HTN DEPRESSION

IBUPROFEN, VITAMIN D, ZINC, TRAMADOL, CRANBERRY, DULOXETINE, MIRALAX, ACIDOPHYLIS, ATIVAN, ASA, GUAUFENISEN

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

VACCINE ADMINISTERED 01/06/21 ACQUIRED COVID 19 01/10/21 RESIDENT HAD MULTIPLE CO MORBIDITIES AND WAS DECLINING PRIOR TO VACCINE. RESIDENT EXPIRED ON 01/25/2021

COVID 19 01-10-2021 GERD DELUSIONS VASCULAR DEMENTIA WITH BEHAVIORS INSOMNIA CHRONIC DVT LEFT LOWER EXTREMITY HEMOCHROMATOSIS PSYCHOSIS MAJOR DEPRESSIVE DISORDER WITH ANXITY IMPULSE DISORDER VITAMIN DEFICIENCY EDEMA CONSTIPATION HALLUCINATIONS HYPOTHYROIDISM HX OF SKIN CANCER CARPAL TUNNEL LT HAND DYSTHYMIC HTN

zinc, acidophylis, albuterol inhaler, vitamin d, mirtazapine, Pepcid, vitamin c, Lasix, magnesium oxide, Depakote, cranberry, melatonin, Zoloft, folic acid, pericolace, simethicone, xarelto, asa, mvi with mineral, synthroid, evista,

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Resident expired on january 21, 2021

Resident started manifesting loss of appetite and body weakness on January 10,2021 a few days after vaccination. She expired in our facility 1/21/2021.

Metoprolol Tartrate Tablet 25 MG BID Norvasc Tablet 10 MG (amLODIPine Besylate) QD Namenda Tablet 5 MG (Memantine HCl) BID Cozaar Tablet 100 MG (Losartan Potassium) QD hydrALAZINE HCl Tablet 25 MG TID Amiodarone HCl Tablet 200 MG QD CloNID

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

ASYMPTOMATIC

NONE

Gabapentin Capsule 100 MG, Give 1 capsule orally one time a day for (NEURALGIA) Losartan Potassium Tablet 50 MG, Give 1 tablet orally one time a day for (HYPERTENSION) HOLD IF SBR<110 OR HR<60 Norvasc Tablet 5 MG (amLODIPine Besylate), Give

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

about 20+ hours after vaccination resident was having hard time breathing, 911 was called. Resident coded multiple times at the facility after CPR she was taken to ICU. She coded again and was placed on life support. Due to her choice to not be on life support she passed on 11/26/2021.

acute pancreatitis, gerd, ibs, OA, rheumatoid arthritis, HTN, H/o falls, osteoporosis, pre-diabetes, hyperlipidemia, diverticulosis, interstitial lung disease, permatomyoitis

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

cough congestive heart failure death

No current illness for this event.

Lisinopril, ASA, Paxil, Amlodipine

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient has a history of advanced melanoma with brain metastasis. He developed seizure disorder as well and had some mild seizures at home over the prior month. He received the vaccine at 4pm and was monitored in the office for 15 minutes. He then went home with his daughter whom he lives with. He ate dinner with her and read until 8pm when he went to his room. She found him in his room at 9pm unresponsive with seizures. Hospice was alerted and recommend oral valium. He continued to be unresponsive and expired the following day at 7:30 pm.

1. Melanoma with brain metastasis 2. Seizure disorder

Tramadol, Dexamethasone, Pantoprazole, Dilatin, Plaxis, Aspirin, VImpat, Keppra, Clopidogrel

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Resident received the first dose of Moderna Vaccine on 01/12/2021 and Tested for COVID-19 on 01/12/2021. Resident tested positive on 01/13/2021. Resident was transferred to acute hospital on 01/19/2021 due to desaturation. Resident expired at Hospital on 01/24/2021.

None

Metformin 500mg PO BID for DM Phenobarbital 97.2mg QD for Seizure Dilantin 100mg, 2 caps, QHS for Seizure Eliquis 5mg BID for DVT Lipitor 10mg QHS for Hyperlipidemia

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient found dead in home the next morning. May or may not be connected to vaccination. Instructed to report it from our medical director and director of nursing.

None

Warfarin, Tamsulosin, Metoprolol, Vitamin D3, Lasix

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient developed SOB but reported good O2Sats. Instructed on going to ER if worsening symptoms. Patient eventually expired on 1/22/21

CHF, hypertension, type 2 DM

Pravastatin 40 mg, KCL ER 10meq, Metoprolol 25 mg, losartan 100 mg, glyburide 2.5 mg, furosemide 40 mg, ASA 81 mg, amlopidine 10 mg, allopurinol 300 mg

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and fell at 3 AM on 1/23/2021. She felt poorly and did not know her son's name which was not normal. She went to ER on 1/24. She was assessed as not having fractures. She was going to be transferred to a skilled nursing facility. She was not having respiratory complaints. She was awaiting transfer when her O2 levels started dropping substantially. She declined aggressive intervention and she died within a few hours.

chronic copd is stable condition; no illnesses at time of vaccination

dexamethasone, losartan, amlodipine, Ensure supplement drink

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient went to hospital with COVID symptoms on 01/10/2021 and passed away on 01/22/2021

"not known. I spoke with his wife when he was in the hospital a couple of days after the first dose of Moderna vaccine. She mentioned that he felt ill a few days before and up to the vaccine date. Despite feeling ill, he checked off ""no"" on the questionnaire section that asked if patients were feeling ill that day."

metoprolol, atorvastatin, furosemide, metformin, trulicity, glipizide, omeprazole, gabapentin, loratadine, losartan, amlodipine

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient died 3 days post Moderna vaccine.

None

Unsure

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Stroke, death

No current illness for this event.

multiple, unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Systemic: Other- Death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

died 01/16/2021

unknown

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient presented to the Emergency Department complaining of chest pain, pale, cool diaphoretic, and hypotensive. The patient was discovered to have a large saddle pulmonary embolism, went into cardiac arrest and expired. Of note, the patient received her second Moderna COVID vaccine on 1/23, which would place her first one approximately 12/25 if she received them at the appropriate interval. This information is from the patient's daughter and the ED record, the information is not available in CAIR. Per the daughter, the patient started feeling ill on 1/21, improved on 1/25, and then acutely worsened on 1/27, resulting in the ED visit.

No current illness for this event.

albuterol, fluticasone nasal spray, hydrochlorothiazide, losartan

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

UNKNOWN/ASYTOLE Narrative: Please refer to section 6. 68y/o male with h/o severe peripheral vascular disease with previous left AKA 2/3/20, s/p bilateral bypasses in the past. Pt recently underwent right AKA on 1/12/21. Per Hospital remote data 1/10/21 pt c/o shortness of breath, CXR demonstrated right lower lobe opacity & left basilar infiltrate. Pt s/p >10 days emperic IV abx. Moderna vaccine 0.5ml IM was administered via left deltoid on 1/22/21 around 16:21. On 1/23/21@05:14 code blue was called as pt found to be unresponsive, breathless and pulseless, facial cyanosis noted, CPR started immediately.Pt found to be in asystole. ACLS guideline followed but no return of spontaneous circulation, At 05:32 pt remained pulseless and breathless and was pronounced. Autopsy currently pending.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

weakness and fallsNarrative: 95 yo male w/ a PMH significant for Afib, legal blindness, Hx of CVA, cognitive impairment, GERD, HTN, pseudogout, BPH, chronic knee infection, and DJD who received his first dose of the Moderna COVID-19 vaccine on 01/08/21. The pt's COVID-19 screening questionnaire prior to receiving the vaccine was negative. The pt presented to the ED on 01/13/21 for weakness and m PCR test on ultiple recent falls (since receiving his first dose of the COVID-19 vaccine). The pt's COVID-19 01/13/20 was positive and he was admitted. He was started on treatment with remdesivir + dexamethasone on 1/14. The pt initially required supplemental oxygen via low-flow NC, however his oxygen requirements increased to 100% NRB. On 01/16/21 his MPOA elected for hospice care. The pt passed on 01/17/21. Unclear if the COVID-19 vaccine attributed to the patient's hospitalization and eventual death, or whether these events occurred from COVID-19 itself, however this case is being reported the FDA since this vaccine is under an emergency use authorization (EUA).

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient died at hospital on j/16/2021 approximately 48 after receiving vaccination. Believe death related to fall at home prior to vaccination.

Patient fell at home night before vaccination.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Worsening respiratory failure 1/20/2021 death 1/27/2021

Chf, CKD

Eliquis, Lasix, metoprolol

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Client's sister called crying and said the family just found out yesterday that Client had died some time last week. The last time any family talked to him was on the 19th of January, missed calls show on the phone on the 21st. His last internet search was sternum pain. . She will also call the Agency and report this. The vaccine isn't in Registery at this time, do I don't know the lot number but she said he was due back in one month. She said he was very healthy and ran triathalons.

none

diclofenac

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

patient received COVID vaccine on 1/11/2021 and passed away on 1/25/2021

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Pt presented to ER via EMS at 1556 3 days after receiving vaccine. pt was breathing approximately 50 times a minutes and o2 sats in the 70's upon arrival. NP decided to intubate, Rocuronium and Versed given. Pt became bradycardic and 1 amp of Atropine was given without improvement. No pulse felt, CPR started per ACLS protocol. 7 Epi's given. Time of death- 1632. After TOD pt was swabbed for COVID-19 and the results were positive.

GI Bleed and Anemia- DX: 1/31/2021

Crestor 10 mg po daily Norvasc 10 mg po daily benazepril 20 mg po daily Gabapentin 600 mg po daily Toprol XL 100 mg po daily

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Death Narrative: Patient with Severe Dementia and on Hospice for end of life care.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Pt started complaining of chest heaviness and shortness of breath on the afternoon of 1/21/21. EMS was called to the patients home and she was found to have an O2 sat in the 70's. She was admitted to hospital and found to have a proBNP of 5000. She tested negative for Covid-19. She was determined to be in acute-on-chronic heart failure and was referred for hospice care. She passed away on the evening of 1/24/21.

Heart failure with reduced EF, history of moderate pulmonary hypertension, history of moderate mitral valve regurgitation and moderate pulmonary valve regurgitation. History of A. fib.

Furosemide 20mg 2poBID, Warfarin 5mgQD, Omeprazole 20mg BID, Propanolol 10mg BID, atorvastatin 40mg QD, vitamin D 1000IUQD

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Jan., 2021

Patient was feeling dizzy and under the weather after the vaccination. The following day he died in his sleep during a nap.

Yes, but caller does not know what they are.

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Unknown Date

Death Chest pain; irreg heart rhythm; evening of vaccine; death on toilet on 1/13/21

No current illness for this event.

ANORA, Albuterol, Flovent, Bumex, Carvediol; omeprazole

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

65+ years

Unknown Date

No adverse events noted Patient past away was notified by Public Health the record is at Vital Statistics

No current illness for this event.

Budesonide/formoter Fish Oil Aspirin Albuterol Terazosin Potassium Pantoprazole Metoprolol Metolazone Levothyroxine Furosemide Alopurinol Apixaban Lactobacillus Acidophilus

COVID19 (COVID19 (MODERNA)) (1201)

DEATH

Unknown

Dec., 2020

death of unknown cause; Swelling on Right side of the neck and under chin; Warmth on right side of neck and under chin; Redness on right side of neck and under chin; A spontaneous report was received from a healthcare professional concerning an 89-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of redness, warmth and swelling on right side of neck and under chin, and death of unknown cause. The patient's medical history included Alzheimer's and chronic obstructive pulmonary disease (COPD). No concomitant medications were reported. On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient experienced the events of redness, warmth and swelling on right side of neck and under chin. There was no indication that the patient was transferred out to hospital, which was unlikely because she was under hospice care. On 01 Jan 2021, the patient died due to an unknown cause of death. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 01 Jan 2020. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 89-year-old, female subject with a medical history of Alzheimer's and chronic obstructive pulmonary disease (COPD) who experienced redness, warmth and swelling on R side of neck and under chin and expired from an unknown cause. The events of redness, warmth and swelling on R side of neck and under chin occurred 2 days after administration of the first and only dose of the mRNA-1273 vaccine and patient expired 4 days after mRNA-1273 vaccine administration. Lot # of the vaccine was not provided. De-challenge and re-challenge are not applicable. The events of redness, warmth and swelling on R side of neck and under chin are temporarily associated with the administration of the mRNA-1273 and thus, a causal relationship cannot be excluded. Due to limited information, the fatal outcome was considered unrelated to mRNA-1273 administration pending additional information. Fatal outcome is confounded by the patient's underlying condition and advanced age.; Reported Cause(s) of Death: Unknown cause of death

Alzheimer's disease; COPD

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

1-2 years

Dec., 2020

death by suicide Narrative: death by suicide; 12/26/20, self inflicted gun shot wound; found deceased by family member

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

18-29 years

Jan., 2021

Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics, IV fluids, cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours. Unfortunately, he suffered a cardiac arrest on 1/21/21 in the early morning and expired.

none

Amantadine, clonazepam, clobazam, lovenox, dextroamphetamine-amphetamine , famotidine, gabapentin, keppra, robinul, polyethylene glycol, propanolol, sertaline, senna, valproic acid, vimpat, cefepime

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

30-39 years

Dec., 2020

LTCF Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead received a call indicating that a staff member deceased somewhere between 1/3/2021 and 1/4/2021. Cause of death is unknown, and an autopsy is being performed.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

30-39 years

Jan., 2021

Expired on 1/12/2021; unknown cause of death

Received 1st Covid vaccine 12/18/2020; 2nd 1/7/2021. This patient is now deceased 1/12/2021.

Unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

40-49 years

Dec., 2020

unsure if related to vaccine, but was notified by her next of kin that she died on 1/4/2021. No reports of side effects or hospitalization were reported to the facility prior to the notification of death.

unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

40-49 years

Dec., 2020

Patient unexpectedly died on o1/6/2020. No known signs or symptoms.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

40-49 years

Jan., 2021

Death unexplained; This is a spontaneous report received from a contactable pharmacist via regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202101140831416270. Sender's (Case) Safety Report Unique Identifier: GB-MHRA-ADR 24595177. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0739, expiry date not reported) via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 vaccination. The patient had not had symptoms associated with COVID-19, not had a COVID-19 test. She was not enrolled in clinical trial. She was not pregnant. She had no pre-existing medical conditions, no allergies, no history of anaphylaxis, no bleeding disorders / blood thinning medication. The concomitant medications, if any, were not reported. The patient was not registered at the practice. The patient did not experience direct or immediate reaction at the time of the vaccine. The practice was informed that approximately 6 hours post vaccine the patient had passed away. The patient died on 13Jan2021. An autopsy was not performed. The cause of death was unknown, death unexplained. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

40-49 years

Jan., 2021

Expired in sleep on 1/24/21

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

40-49 years

Jan., 2021

Was at work on 1/26/21 and collapsed, no known complaints a the time. CRP was initiated immediately, transported to ER and pronounced dead

immunocompromised with reportable conditions

unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

"Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe. 911 was called and taken to the hospital. While in the ambulance, patient coded. Patient was given CPR and ""brought back"". Once at the hospital, patient was placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the ventilator on 1/9/2021 and passed away at 1:30am on 1/10/2021. The initial indication from the ICU doctor was the patient had a mucus plug that she couldn't clear."

Recent g-tube placement, Several hospitalizations over the pas few months due to low Oxygen Levels.

Aspirin, Diazepam, Doxepin HCL, Duloxetine, Juven POW, Lamotri Levothyroxin, Loratadine, Melatonin, Mucus Relief, Olanzapine, Prazosin HCL, Pregabalin,

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away

No current illness for this event.

; ; ;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12th He works at the extended care community and was in good health that morning with no complaints. He waited 10-15 minutes at the vaccine admin site and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the 2nd vaccine. EMS called immediately worked on him 30 minutes in field then 30 minutes at ER was able to put him on life support yet deemed Brain dead 1-14-21 and pronounced dead an hour or so later

No known new illnesses,

losartan, spironolactone, carvedilol

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff will continue to observe adverse reaction. Will continue to monitor. Patient at start of shift awake in the bed. Pt at 3am was on the commode leaned to the side. Patient body still warm to touch no pulse. Called for assistance Asap. Cpr started promptly. Cpr given patient on floor 911 arrived at the scene at 3:10am Cpr rotated Between Nursing and EMT on Scene. Cpr was given to patient for over 45 minutes. Patient was pronounced at the scene at 3:50am. Call placed to Pt family by supervisor on shift. MD to be notified. AT 3:00am, I was notified by the nurse that resident is unresponsive. Upon entering room, resident was sitting on the commode unresponsive with absent respiration and pulse. Resident lowered down on the floor with 4 person assist. CPR initiated, AED pads placed on chest with no shock indicated. 911 called and EMT and paramedics arrived around 3:10am. ACLS performed until code stopped and pronounced death at 3:48am. I called and notified family member of his demise and awaiting for family to call us back for funeral arrangements.

Cellulitis of RLE, S/P wound debridement

Lantus SoloStar; Atorvastatin Calcium; Gabapentin; Potassium Chloride ER; Levothyroxine Sodium; Alogliptin Benzoate; Acetaminophen; Milk of Magnesia; Enema Rectal; Bisacodyl Rectal Suppository; Tramadol HCl; Ceftriaxone Sodium; Santyl Exter

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

Death

No current illness for this event.

Levothyroxine Calcium Acetate Albuterol Clonidine Hydralazine Ropinirole Aspirin Ergocalciferol Metoprolol Ondansetron Rifaximin Hydroxyzine Mutlivitamins Buspirone Pantoprazole Oxycodone Atorvastatin

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 911 called at 12:11am. FD and EMS arrived, resident pronounced at 12:51am.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

Death 3 days after receiving 2nd dose of COVID vaccine, unknown if related to vaccine administration.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

The employee found dead at her home on 1/21/2021.

not known

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

Patient expired - autopsy preformed - cause of death not related to COVID-19 vaccination according to coroner.

Unknown - Smoker

Unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

Systemic: patient had no known medical history per supervisor

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

50-59 years

Jan., 2021

Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1/27/21. At approximataely 16:30, patient complained of abdominal pain and was given Levsin 0.125mg and morphine 5mg orally. At approximately 19:30 patient was found on the floor covered in a large amount of emesis, unresponsive without a pulse.

No current illness for this event.

Acetaminophen Suppository Insert 650 mg rectally every 6 hours as needed for pain 1-3 Bisacodyl Suppository 10 MG Insert 1 suppository rectally every 24 hours as needed for constipation COVID-19 mRNA Vaccine (Pfizer) Suspension 30 MCG\/0.3M

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Dec., 2020

RESIDENT CODED AND EXPIRED

none

Asa-81mg, Lisinopril 10mg daily, ferrous sulfate-325, MVI with min, zyprexia-20mg, Flomax-0.4, famotidine-20mg, vit C, carbamazepine-250mg bid, Depakote-750mg bid, metformin-1000 bid, sertraline-100 bid, albuterol,buspar-10mg TID, Fibercon-

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Dec., 2020

Death by massive heart attack. Pfizer-BioNTech COVID-19 Vaccine EUA

None

Atenolol, Chlorthalidone, Tamsulosin

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Dec., 2020

Resident expired on 1/2/21.

Receiving hospice services

Keppra, Levothyroxine, Miralax, Olanzapine, Trazadone, Risperidone, and Lorazepam

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Dec., 2020

Patient deceased

No current illness for this event.

TRAMADOL, CHOLESTYRAMINE, DICOLFENAC SODIUM TOPICAL GEL, GABAPENTIN, TRAZODONE, LEVETIRACETAM, HYDROXYZINE HCL, FUROSEMIDE, DIVALPROEX SODIUM, ELIQUIS, LEVOTHYROXINE

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Dec., 2020

Death - Hospice patient with metastatic CA admitted to facility and received vaccine during stay. No adverse sequelae noted from vaccine administration, but reporting as required because pt died 7 days later. Narrative: Reporting this event because patient died 7 days after receiving vaccine in the facility where he was in hospice care for metastatic cancer. Vaccine was administered by protocol without complications. The patient had been asked and denied any prior severe reaction to this vaccine or its components and gave permission to receive it. No vaccine adverse sequelae were documented after the immunization as monitored for 15 minutes nor in facility notes for 7 days after the immunization. The patient's death was felt to be due to underlying terminal illness.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Dec., 2020

respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a

No current illness for this event.

LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; ATIVAN

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Dec., 2020

All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting. Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair. Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583. Resident deceased upon re-check after calling PCP to report status change.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Dec., 2020

Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.

Ongoing Sinus and ear infections being treated by PCP

Cetirizine 10 mg, Haloperidol 5 mg, Sertraline 50 mg, Albuterol HFA 90 mcg (PRN), Diphenhydran 25 mg (PRN), Fluticasone 50cg PRN, Lactulose 10 gm/15 (PRN), Polyeth Glycol 17 gm (PRN), Neomycin/Polymyxin drop, Amoxicillan 500 mg, Methyldredn

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Jan., 2021

Patient died, I have a copy of his vaccination card

Unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Jan., 2021

Difficulty breathing, death.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Jan., 2021

Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64. He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.

None

Amlodipine, Lipitor, Lisinopril

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Jan., 2021

approximately 3 hours prior to expiring the patient was experiencing forceful emesis. later was found to have expired, patient was comfort care only.

none

Phenergan, melatonin, clonazepam, vit d, asorbic acid, zinc, cholecalciferol, lomotrigine, cimetadine, quetiapine,

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Jan., 2021

Patient was was brought to the ED from facility which he received the vaccine via ambulance with BiPAP, hypoxia, and one dose of Epi of 0.3 mg. He then required intubation, and had struggled with hypoxia, even on increasing PEEP. CODE BLUE called in the ED for PEA. He was medicated for such (please see the code run sheet for details), and he came in and out of the code 5 times. After 95 minutes, with the wife at the bedside, and family conference by phone, the code was called, and he was pronounced at 18:20. He received in total 8 me of Epi, 3 shots of Atropine, 3 amps bicarb. He got lasix 40 mg, lovenox 60 mg subcutaneous once. He had a CVC into the right internal jugular, and levophed was started, then Epinephrine drip was started. Prior to the code he got steroids (solumedrol 125 mg, then later decadron 6 mg iv), benadryl iv, antibiotics (ceftraixone / zithromax), and lasix 40 mg. All this time while in the ED, the Rt was at the bedside, and lots of secretions from the lungs were aspirated, bloody color. á Code was the result of PEA secondary to hypoxia (

HTN, DM2. COVID-19 infection, 12/24/20.

AMLODIPINE BENZOATE , ATORVASTATIN CALCIUM, áLOSARTAN POTASSIUM, METOPROLOL SUCCINATE, metFORMIN

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

60-64 years

Jan., 2021

"""We held our COVID 19 vaccination clinic in our facility on 1/5/2021 with partnership of a pharmacy. One of our housekeeping staff (63 year old male) who had confirmed to be vaccinated, came to the facility and was vaccinated by the pharmacist with Pfizer vaccine. The pharmacist explained the facts of vaccine and the employee signed the consent form for the vaccine. He was monitored in our observation area under the supervision of an RN post vaccination for 15 minutes. He did not complain of any side effects and did not appear to be in any distress. Per daughter, employee went to his pharmacy in the evening some time after leaving the facility. Daughter reported that he called his wife from the pharmacy and asked his wife to come and pick him up as he did not feel well. His wife went to the pharmacy and found him in the parking lot where he gave her his medical card and asked her to get his medication from the pharmacy. His wife went to pick up the medication and upon her return, found him in the car in the passenger seat. The daughter reported that he took the medicine that the wife brought from the pharmacy while in the car. His wife drove him home and upon reaching home when she tried to get him out, he was unresponsive. His wife called her children to help her and there was no response. Family called the paramedics and he was pronounced dead. I have informed pharmacy and they are reporting to FDA per their protocol. PHD has been notified as well and they are doing their reporting per their procedure. Daughter reported that employee had a history of heart disease and diabetes and had a pace maker."""

At the time of the clinic when the patient filled out the VAR form, he did not indicated any health issues. However, according to an e-mail the Health Care Facility sent us, he had a history of heart disease, diabetes, and a pace maker.

n/a

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Vaccine administered with no immediate adverse reaction at 11:29am. Vaccine screening questions were completed and resident was not feeling sick and temperature was 98F. At approximately 1:30pm the resident passed away.

No current illness for this event.

Gabapentin 100mg, Memantine 10mg

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

the patient died; This is a spontaneous report from a contactable consumer through a Pfizer employee. A 98-99 years old patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration possibly on 27Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died on 29Dec2020. Event details: The Pfizer employee was informed, by a member of the Covid vaccine team at the ministry of health, that an elderly person 98-99 years old, who used to stay in an elderly home, who also had other serious diseases and received the vaccine possibly on 27Dec2020, had died this morning (29Dec2020). As it was mentioned to the Pfizer employee, they were 'sure' that the cause of death did not related to the vaccine. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: unknown cause of death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Spouse awoke 12/20 and found spouse dead. Client was not transferred to hospital.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Within 24 hours of receiving the vaccine, fever and respiratory distress, and anxiety developed requiring oxygen, morphine and ativan. My Mom passed away on the evening of 12/26/2020.

none known

Contact facility for medical records. We think levothyroxine daily and ativan prn.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Injection given on 12/28/20 - no adverse events and no issues yesterday; Death today, 12/30/20, approx.. 2am today (unknown if related - Administrator marked as natural causes)

Alzheimer's Disease, Encephalopathy, Hypertension,Acute Kidney failure, Urine Retention, Recent UTI

Senna Plus, Loperamide, Ondansetron, Acetaminophen, Mucus & Chest Relief cough syrup, Oystershell Calcium Plus D, Vitamin D3, Escitalopram, Bupropion, Hydrocodone/Acetaminophen, Bisacodyl Suppositories

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

pt passed away with an hour to hour and 1/2 of receiving vaccine. per nursing home staff they did not expect pt to make it many more days. pt was unresponsive in room when shot was given. per nursing home staff pt was 14 + days post covid

per nursing home staff over 14 days post covid

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

pt was a nursing home pt. pt received first dose of covid vaccine. pt was monitored for 15 minutes after getting shot. staff reported that pt was 15 days post covid. Pt passed away with in 90 minutes of getting vaccine

No current illness for this event.

not known

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

pt received vaccine at covid clinic on 12/30 at approximately 3:30, pt vomited 4 minutes after receiving shot--dark brown vomit, staff reported pt had vomited night before. Per staff report pt became short of breath between 6 and 7 pm that night. Pt had DNR on file. pt passed away at approximately 10pm. Staff reported pt was 14 + days post covid

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Resident received vaccine per pharmacy at the facility at 5 pm. Approximately 6:45 resident found unresponsive and EMS contacted. Upon EMS arrival at facility, resident went into cardiac arrest, code initiated by EMS and transported to hospital. Resident expired at hospital at approximately 8 pm

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Resident received vaccine in am and expired that afternoon.

Resident was living in an assisted living facility. She fell on 11/24/2020 and was seen in the ER. There, she tested positive for COVID 19. She was admitted to this facility for rehab. She showed a decline after admission and was referred to hospice.

ASA 81, Vitamin D, Vitamin B12, Atorvastatin, Omeprazole, Tylenol, Donepezil, Amlodipine, Coreg, Remeron

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue

No acute illness at time of vaccination. History of: CVA SCPT Dementia Seizure Disorder HTN COPD

Albuteral Sulfate Amlodipine Carvedilol Ipratropium Levetiracetam Olanzapine Sodium Chloride Symbicort Valproic Acid

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Vaccine 12/30/2020 Screening PCR done 12/31/2020 Symptoms 1/1/2021 COVID test result came back positive 1/2/2021 Deceased 1/4/2021

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

"deceased on 31Dec2020 with no previous side effect; This is a spontaneous report from a contactable physician via ""Pfizer"". An 87-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ""not known because vaccination team vaccinated at care home""), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included upper respiratory tract infection, changing patient weakness; both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced: deceased on 31Dec2020 with no previous side effect; which resulted in death on 31Dec2020. The clinical course was reported as follows: the patient received the first dose of the PFIZER-BIONTECH COVID-19 MRNA VACCINE on 29Dec2020; and the patient was deceased on 31Dec2020 with no previous side effect. The patient received the vaccination with a negative COVID-test on 25Dec2020; ""in case of upper respiratory tract infection and changing patient weakness"". The physician reported that ""after good breakfast at 09:13 found without vital signs during routine control."" The clinical outcome of the event was fatal. The patient died on 31Dec2020 due to unknown cause of death. It was unknown if an autopsy was performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: The limited information available does not allow a meaningful assessment by the company. The advance old patient had upper respiratory tract infection, changing patient weakness; further information such as complete medical history, concomitant treatments, particularly death cause and autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: deceased on 31Dec2020 with no previous side effect"

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Vaccine given on 12/29/20 by Pharmacy. On 1/1/21, resident became lethargic and sluggish and developed a rash on forearms. He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of codition reported, doctor and Hospice ordered comfort meds (Morphine, Ativan, Levsin). Resident expired on 1/4/2021

Dementia Chronic PVD

Vitamin D3 5000 units qd Furosemide 20mg qd Olanzapine 2.5mg bid

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Expired 1/05/2021

Acute on chronic heart failure, sepsis

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021

dementia, Upper gastrointestinal bleed

Lorazepam, pantoprazole, miralax, senna plus, carbodopa-levodopa, metoprolol, mirtazipine, quetiapine

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

patient declined 12/30/2020 and was transferred to hospital where he did not respond to treatment and passed away 1/4/2020

chronic medical problems as noted below

alprazolam, amlodipine, ASA, cilostazol, advair, lamotrigine, ,losartan, metoprolol,omprazole,simvastatin

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

possible myocardial infarction; Dyspnoea; unwell; Cough; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency. Regulatory authority GB-MHRA-WEBCOVID-20210105105739, other manufacturer number is GB-MHRA-ADR 24556743. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ0553-v0003), via unspecified route of administration on 19Dec2020 at single dose for COVID-19 vaccination. Medical history included diabetes mellitus, angiocardiogram, cardiac failure, hypertension, all from unspecified date and unknown if ongoing and cerebrovascular accident from 2001 and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Unsure if patient is enrolled in clinical trial. Concomitant medication included amlodipine, acetylsalicylic acid (ASPIRIN (E.C.)), atorvastatin, bisoprolol, fluticasone propionate (FLIXONASE), folic acid, colecalciferol (FULTIUM-D3), furosemide, latanoprost, levothyroxine, insulin aspart (NOVORAPID), ramipril and insulin detemir (LEVEMIR). On 24Dec2020, the patient experienced a cough. It was noted that the patient's son and wife had already been coughing but no coronavirus tests had been done at the time of this event. On an unknown date, the patient experienced dyspnoea. It was noted that the he had become increasingly short of breath and unwell. On 28Dec2020, the patient died. It was noted to be a possible myocardial infarction. The patients COVID test score was unknown. The autopsy was awaited at the time of this report. The outcome of the event possible myocardial infarction was fatal, while other events were unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: possible myocardial infarction

No current illness for this event.

; ASPIRIN (E.C.); ; ; FLIXONASE; ; FULTIUM D3; ; ; ; NOVORAPID; ; LEVEMIR

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Systemic: reported by staff patient expired under suspicious circumstnces after receiving vaccine. Patient was on hospice, reported not expected to pass this soon; symptoms lasted 0 days

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Resident expired on 12/30/20, dx cardiac arrest.

None

Diazepam, Levothyroxine, Magnesium Oxide, Olanzapine, Omeprazole, Sertraline, and Vitamin D3

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Has underlying dementia and often with difficulty eating. 1 week after immunization she developed a stroke with left sided weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should report

Nothing acute prior

depakote, lexapro, lisinopril, multiple vitamin, senna, seroquel, tylenol

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Patient became sick 3 hours after the vaccine and was found deceased 1 day after his vaccination. He passed away in his sleep.

None: Clean bill of health and a full cardiac exam was performed 2 months prior.

Amoxicillin 500mg

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

The day following the vaccine, the patient complained of throat issues and anxiety. This was not new... however . That evening he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative. On 12/30/2020, patient complained of sternal pressure and was transferred to the hospital. The patient died 12/31/2020 and records obtained from the hospital indicated the patient died from a massive myocardial infarction.

Diabetes, COPD, Chrone's Disease, DJD, OSA, PTSD, GERD, HLD, Depression, HTN, lobectomy 3/4/2019, cancer

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

patient received vaccine 12/29. Unexpected death 1/5.

CAD s/p CABG, prior ischemic HFpEF (EF 45% > 50%), mild-mod Mitral Stenosis, bradycardia s/p PPM, HTN, HLD, DMII (A1C 6.5), CKD (baseline Cr 2-2.5), GERD, BPH, seizure disorder (on keppra)

aspirin atorvastatin bumetanide carvedilol vit d 3 miralax tamsulosin tylenol keppra lisinopril mirtazapine pantoprazole senna

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Death on 1/15/2020

No current illness for this event.

Melatonin, Sertraline, Omeprazole, Resperidone, Depakote ER, vitamin E, multi vit, ASA, Lasix, gabapentin, potassium, Imodium, Zofran, Buspar, benztropine.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Unknown as to any correlation with vaccine as this was a hospice patient that was already experiencing decline. Patient became Jaundice for approximately one week prior to expiring.

Alzheimer's disease, Type 2 with chronic kidney disease,

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Per Nursing Staff- patient died within 24 hours of receiving the vaccine. patient has hospice. Please contact director of nursing for more details.

Tachycardia, Hypertension

unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

per staff at facility patient died 24 hours post vaccination. Please contact Director of Nursing for further details.

Unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

"died; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A 97-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 at 97-years-old at a single dose for COVID-19 immunization; administered by the nursing home. Medical history included glaucoma from an unknown date and unknown if ongoing. Concomitant medications included: ""used a sav for skin tears"", and ""eye drops for glaucoma"" from an unknown date to an unknown date. On 07Jan2021, the patient experienced: tested positive for COVID (medically significant). The patient died (death, medically significant) on 17Jan2021. The clinical course was reported as follows: The reporter stated that in regard to the patient's height and weight: ""was probably getting down to about five foot eight. Shrinking."" The reporter stated that If she remembered correctly, they were trying to maintain the patient's weight 135 to 136 pounds. The reporter stated that her father was in a nursing home. The patient received his first dose of the COVID vaccine on 30Dec2020. The patient died on 17Jan2021. The reporter stated that she ""wanted Pfizer to know that the little old people in the nursing might not be strong enough for the vaccine."" The reporter stated that she was ""not calling to complaining."" The reporter stated that there was nothing wrong with her dad. He was elderly with no health issues. ""He was literally on no medications. The only reason he was in the nursing home was because he was afraid to walk."" The reporter stated that she received a call about giving the patient the vaccine and she said yes because she wanted him to have the vaccine. One week after the vaccine, the patient tested positive for COVID ""like all the other people"" (no further details provided). The reporter stated that her dad had no symptoms of COVID. The director of nursing said the patient was doing so well. The patient ate his lunch, he laid down for nap, and at 14:30 he was gone. The patient ""went peacefully in his sleep."" The reporter then again stated that the patient literally had nothing wrong with him. ""They were shocked. They fed him and he took a nap. He was sleeping, but it was eternally."" The reporter stated that, ""it might not have been the Pfizer vaccine, maybe his heart wore out."" In regard to an autopsy: the reporter stated that they would get it done if needed. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 07Jan2021. History of all previous immunization with the Pfizer vaccine considered as suspect: none. It was unknown if there were additional vaccines administered on the same date of the Pfizer suspect, but the reporter doubted it. There were no prior vaccinations within 4 weeks. There were no adverse events following the prior vaccinations. The clinical outcome of the event, died, was fatal. The clinical outcome of the event, tested positive for COVID, was unknown. The patient died on 17Jan2021 due to an unknown cause of death. An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: died"

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

We do not believe that the patient's death was an adverse event from the vaccine. Patient received COVID vaccine from Pfizer Dose #1 12/19/2020 (lot # EK5730) and Dose #2 1/7/2021 (lot # EL1284). No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Patient died 1/10/2021 from chronic respiratory failure and congestive heart failure after recent aspiration pneumonia requiring hospitalization. Death was anticipated and not sudden. We were told to report his death to VAERS even though his death was anticipated and not related to his vaccination.

Aspiration pneumonia (dx on 12/16/2020)

Acetaminophen suppository 650mg PRN, atropine 1% opthamlic solution, biotine moisturizing mouth solution, lorazepam concentrate 2mg/ml, milk of magnesia suspension 400mg/5ml, morphine sulfate solution 20mg/ml, zofran ODT tablet 4mg.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Patient did not have any adverse reaction to the COVID vaccine, but we were asked by our health dept to submit a VAERS report since the patient died between his first and second dose. Received Pfizer Dose #1 12/17/2020. No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Date of death 12/23/2020 from aspiration pneumonia complicated by end-stage heart failure and ischemic cardiomyopathy. Death was anticipated and not sudden.

Scrotal edema, aspiration pneumonia

acetaminophen suppository 650mg, polyvinyl alcohol solution 1.4%, atropine 1% ophthalmic solution, fentanyl patch 72hr 50mcg/hr, lorazepam concentrate 2mg/ml, morphine sulfate solution 20mg/ml.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Pt on hospice in facility for severe cardiomyopathy unable to perform interventions received vaccine without adverse sequelae died 5 days later. Reporting as required. Narrative: Reporting as required patient death 5 days after immunization with Pfizer vaccine. However, no adverse sequelae were noted to the vaccine in the 15minute observation period, nor in the days following the immunization related to the vaccine. The patient denied any prior severe reaction to this vaccine or its components, and the patient gave verbal consent to receive the vaccine. Patient had been in the facility on hospice since 11/18/20 for severe decompensated HF and newly diagnosed cardiomyopathy, unable to perform interventions, also LE ischemic wounds with very poor potential to heal due to advanced PVD.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Death on 1-5-21

DM, HTN, anemia, gout, BPH, atrial fib, heart failure, CAD, CKD,

Omeprazole, metoprolol, prilosec,, isorbide, senna, nitro, lasix, fluticasone

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Death 1-15-21

Dementia, Bipolar, COPD, HTN, Schizoaffective

prozac, olanzapine, alendronate, divalproex, mirabegron, metoprolol, proair,

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

passed away; This is a spontaneous report from non-contactable consumers received via a Pfizer-sponsored program An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via an unspecified route of administration on 30Dec2020 at a single dose (1 dose) in the left arm (LA) (administered by: senior living) as Covid vaccine. Medical history included patient was 14 plus days post COVID and unresponsive. The patient had no listed allergies. Concomitant medications were not reported. The patient passed away with an hour and half of receiving vaccine on 30Dec2020. Per nursing staff, they did not expect the patient to make it many more days. She was unresponsive in the room when shot was given. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: passed away

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Narrative: Please note that patient is a hospice patient. Death occurred 10 days post vaccination. Providers do not believe that there was a correlation. Facility requires that we reports all death even if we suspect no correlation between death and vaccine. Symptoms: & death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19 outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline, but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital At no time during the hospital stay has she been more than minimal responsive. She need O2 for Comfort but on CXR and CT cardiopulmonary imagining was clear. Discharge note stated that he was requiring supplemental oxygen, but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely, this disease set her level of function back to the point that she was no longer eating and drinking, and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis. On 1/12/2021 family made patient a DNR and IVF were stopped and switched to comforted care. Patient expired 1/13/21

unk

Covid outbreak in the facility tested two week before negative.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Death - unknown cause, no reported side effects Narrative: Unknown cause of death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Patient sent to hospital 1/2 and 1/5. Returned both times to nursing home covid unit without a hospital admission. Resident had been diagnosed with COVID later in the day on 12/30, when routine testing PCR results returned to facility, after resident had already had her first covid vaccination on 12/30/20 in the morning. Resident continued decline, was again sent to hospital on 1/24/21, and expired in hospital 1/25/21.

Left femur fx 12-7-20 UTI 12-7-20

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

"shortness of breath, chest xray with pulmonary edema, periorbital edema Narrative: 73 yo M w/ PMH HTN, HLD, EVAR (2013) for AAA c/b persistent type II endoleak s/p multilple repairs (2015 & 2017) c/b glue embolization down into the R CIA secured with additional stent placement with the R iliac limb, s/p b/l Iliac artery aneurysm stent 08/31/20, and PTSD. Former smoker, quit 12+ yrs ago. 11/1/20-11/6/20: Hospitalized for acute on chronic back pain, found to multiple hypermetabolic lesions in the axial skeleton. Diagnosed with epithelioid angiosarcoma. Patient discharged to facility. 12/17/20: Patient received his 1st COVID-19 vaccine w/o complications at facility. 12/21/20: Underwent cyberknife treatment. 12/31/20: Transferred from facility to ER for new O2 requirement, SOB, cough, chest X ray / pulm edema, tachycardic and new periorbital edema. 12/31/20: Admitted to ICU before transfer to acute care. 1/1/21: Pulmonary consult, ""Labs are notable for progressive left shift with bandemia, markedly elevated inflammatory markers (D-dimer, ESR, CRP, ferritin, LDH), mild elevation in procalcitonin, mild elevation in lactate that has improved, and negative viral panel including COVID-19 x2. CT chest is notable for b/l GGOs along with some interstitial infiltrates with an upper and particularly mid zone and perihilar predominance, septal thickening and crazy paving, and numerous cystic lesions or pneumatoceles. There is a lack of lobar consolidation and pulmonary nodules. Of note, PET/CT about 2 months ago only demonstrated some mild to moderate emphysema mostly in the upper lobes. Therefore, there has been a relatively dramatic change in a few months, suggesting a more subacute process, rather than an acute infectious process such as a viral pneumonia, including COVID-19 infection, in which the GGOs tend to be subpleural and peripheral. Overall, our suspicion for COVID-19 is relatively low, with negative testing x2 yesterday, negative testing a few weeks ago, and lack of sick contacts, but it is possible. Therefore, higher on the differential is a more subacute infection or chemotherapy-induced pneumonitis. Risk factors include malignancy, chemotherapy, and use of steroids (equivalence of about 27 mg of Prednisone in the form of Dexamethasone since 11/6/20 without PJP prophylaxis). These risk factors, along with consistent imaging and elevated LDH, make PJP quite likely. Fungal infection is less likely based on imaging. Chemotherapy-induced pneumonitis is a possibility, especially given the more subacute picture based on imaging. Both Gemcitabine and Docetaxel can cause pneumonitis. However, the patient has been on steroids, which is used to treat drug-induced pneumonitis, although this does not exclude it completely."" 1/2/21: Transferred to ICU for worsening hypoxemia as patient reached 40L/100% FIO2 and remained on COVID isolation/COVID patient under investigation per ID recommendation. 1/4/21: Isolation precautions discontinued due to lower suspicion for active COVID infection to explain current presentation 1/6/21: Went into atrial fibrillation w/o RVR overnight 1/6. Tolerating, with MAPs in low 60s and HR in high 90s/low 100s. Suspect due to being-1L yesterday from diuresis, lasix stopped. S/p amiodarone bolus + drip, albumin 5% bolus 1/5/21: Macrocytic anemia NOS w/ slowly worsening H/H s/p PRBC x 1 unit 1/7/21: Per ICU Life-sustaining treatment note, ""Following discussion w/ patient that his lung dx has been refractory to txt and hasn't improved despite maximal therapy, patient agreed to transition to hospice after he settles affairs. "" 1/7/21 Infectious Disease note: ""This is an immunocompromised host due to cancer on active chemotherapy (albeit ANC>4000 on admission) and notably had been on daily PO dexamethasone 1 mg TID (total daily dose 3 mg, equivalent to 20 mg PO prednisone) since 11/6/20 without any PJP ppx. There was elevated c/f COVID-19 infection in setting of patient's presenting symptoms, especially in conjunction with b/l GGOs on imaging. Has undergone multiple COVID test that have all resulted negative. Discussed radiographic findings with radiology colleagues, and overall, it is difficult to definitively narrow the differential with imaging alone, but overall density of GGOs seem to appear less likely PJP and more in line with chemical pneumonitis vs COVID, although less typical for viral pneumonia as well. Given false-negative COVID tests are not unheard of, especially in the immunocompromised population, patient was kept on isolation precautions as a PUI for abundance of caution. He is now off precautions. In setting of patient having been on prednisone for some time without PJP ppx, he was also started on treatment dose TMP/SMX. Beta-d-glucan has returned positive, and although not the ideal test for PJP, this can certainly support a potential dx of PJP. Unfortunately, DFA from sputum was not performed due to insufficient sample and currently the patient is unable to produce an additional sample for testing. He is tolerating the high-dose TMP/SMX; we adjusted the dose to three SS tablets TID based on his somewhat declining UOP. Other fungal etiologies are pending work-up as well. Lastly, patient's chemotherapy is known to cause pneumonitis, but per pulmonology team, he receives prophylactic dexamethasone with his chemo cycles that should help to prevent drug-induced pneumonitis. Remains on the differential for now and this should also be concurrently treated with the steroids he is receiving."" 1/10/21: Comfort care initiated. All non-comfort measures were discontinued. Time of death: Jan 10,2021@14:56; immediate cause of death per death note is ""hypoxic respiratory failure"""

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Dec., 2020

Pt began experiencing shortness of breath 3 days after vaccine and expired later that day.

Pt was on hospice in LTCF at time of death, but expired 3 days after receiving vaccine. She exhibited shortness of breath the morning of death. 12/7-12/17 covid positive but seemed to be recovering HTN Alzheimer?s

N/A

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

The resident was found deceased a little less than 12 hours following COVID vaccination, and he had had some changes over the last 2 days. He was 96 and had been on hospice care for a little while. Noone noticed any side effects from vaccine after it was given

was under hospice care

Olanzapine, polyethylene glycol, ativan, morphine, senna

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"Pt last seen at 1200 by nurse for ID band check. No visible signs of distress noted. Pt states ""I just want to be left alone"". 1230 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first shock given. 1245 EMT took over, at 1319 EMT called time of death"

Fracture of right superior and inferior pubic rami, fracture of the right sacral alla, and fracture of the L3 vertebral body. UNSPECIFIED PROTEIN-CALORIE MALNUTRITION

Acetaminophen Tablet 325 MG, Enulose Solution 10 GM/15ML (Lactulose Encephalopathy), HYDROcodone-Acetaminophen Tablet 5-325 MG, Milk of Magnesia Suspension 400 MG/5ML (Magnesium Hydroxide, Potassium Chloride ER Tablet Extended Release 20 ME

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient was vaccinated at 11am and was found at the facility in his room deceased at approximately 3:00pm. Nurse did not have cause of death

stroke

unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated, cardiac arrest, died 01/07/21.

Parkinson's Disease with advanced dementia, dysphagia. Alcoholism in remission. HTN. BPH. GERD

ACETAMINOPHEN CARBIDOPA-LEVODOPA CARBIDOPA-LEVODOPA ER CITALOPRAM HBR DONEPEZIL HCL EUCERIN FINASTERIDE FLOMAX LATANOPROST OMEPRAZOLE QUETIAPINE FUMARATE QUETIAPINE FUMARATE SENNA LAX

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

3:07 pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats remained low for next 36 hours ( patient on Hospice care ) expired 6:22 am 1-8-21

Cerebral Atherosclerosis, malnutrition, thrombocytopenia, cva, hypothyroidism

none

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Diarrhea followed by death 24 hrs after vaccination

None

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased

none known

Unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

RECIEVED VACCINE 1/8/21 EXPIRED UNEXPECTED 1/10/21, NO ADVERSE REACTIONS NOTED

PNEUMONIA

CRANBERRY, PROZAC, NEUROTIN PERCOCET, IMMODIUM, SYNTHROID, LINZESS, LIPITOR, MELATONIN METFORMIN, PROTONIX PLAVIX, PROAIR, ropinirole, PROAIR SYMBICORT, THIAMINE TYLENOL VIT C VOLTAREN. ZANAX, ZOFRAN

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Acute anterior MI with death

Had Covid 19 infection in November recovered, had spinal stenosis with leg weakness chronic

tramadol, calcium, Tylenol, lisinopril, Mucinex, MVI, namenda

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient went to bed around 11pm on Saturday PM and sometime between then and 1:30am on Sunday morning got up and went into the living room without waking up her husband (which is normal). At 1:30am, the husband got up to use the restroom and she was out of bed then, but the husband did not know if she was having any problems at this time. When he got up at 7:45am, she was in the recliner and did not move or anything, which is normal for her. At 8:45am, the husband went back into the living room and tried to wake his wife and that is when he noticed there was no pulse and he called 9-1-1 at this time. EMS got on scene and did CPR for 30 mins and she was pronounced dead at 9:21am.

Newly diagnosed heart murmur the week prior by PCP. Was referred to her cardiologist.

Husband only knew that she took several medications.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

There were no adverse reactions. Resident Died, she had a history of issues with her health prior to the vaccine.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

My mother was given Pfizer vaccine on Thursday and she died 3 days later yesterday on Sunday!!!

Pneumomia

IDK

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

loss of consciousness Narrative: Patient received COVID-19 vaccine dose #1 on 1/6/21 w/o complications. Per 1/6/21- 1/9/21 nursing notes, patient did not experience any injection site reactions, denied pain or tenderness at injection site, no dizziness, no n/v, remained afebrile. Around 1/9/21 @1810, patient became acutely nonresponsive after being helped to the edge of bed. Per nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency team called d/t patient's sudden change of condition. Emergency team helped patient into lying position. Per 1/9/21 ICU emergency team note, patient appeared comfortable w/ no palpable radial pulse and had minimal shallow agonal breathing. Pulse ox 94%, HR in 60s per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20 pm.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Resident was found deceased at approximately 6pm in her apartment

Brain bleed, sleep apnea, htn

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Hospice Resident received first Covid 19 vaccine dose on 1/6/21. 1/7/21 resident had decreased appetite noted in am but ate 100% of meal at dinner. 1/9/21 resident had decreased appetite with emesis x 2, loose BM x 2. Call placed to hospice. 1/10/21 5:44 am resident able to take HS meds, ingest 2 cups of shake. No emesis or loose stool noted. 12PM nurse noted resident not eating meals but ingesting milkshake and medications without any problems. Hospice contacted for change in condition. 1:00 pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN. Labs to be drawn 1/11/21. Hospice notified POA. 1/11/21 12:24am Resident had blood in stool. Resident denies any pain, on 2L of O2 for comfort.

Hospice

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

patient passed away after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular into the right arm on 07Jan2021 at 0.3 mL, single for covid-19 immunization. There was no medical history and no concomitant medications. On 08Jan2021, the patient passed away after receiving the COVID vaccine. The patient died on 08Jan2021. An autopsy was not performed. Investigations indicate that unspecified labs were done, but nothing two weeks prior; no further details were provided. The patient received the first dose the day prior. The reporting nurse discussed it with the medical director, and he thought that he potentially passed away from the COVID vaccine. The relatedness of the event to the suspect vaccine was reported as related by the reporting nurse per The Agency. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the limited information available, it is medically not possible to make meaningful causality assessment, it is unlikely the vaccine could have contributed to the death of the patient based on the known safety profile. However case will be reevaluated when additional information is received during the follow-up The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Stated that the patient passed away after receiving the Covid vaccine

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"Heart attack; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: and Expiration Date: Unknown), via an unspecified route of administration in the left arm on 05Jan2021 at 13:00 at a single dose for COVID-19 immunization; administered in doctor's office/urgent care. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021, the patient experienced heart attack; which resulted in death and was assessed as medically significant. The patient also experienced the associated symptoms of cold sweats, chest pain, shortness of breath. Therapeutic measures were taken as a result of heart attack, which included ""life saving measures"" by the paramedics performed upon arrival with no success. The clinical outcome of the event, heart attack, was fatal. The patient died on 05Jan2021 due to heart attack; as ruled by the paramedics. It was unknown if an autopsy was performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart attack"

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown"

No current illness for this event.

; ; EFFEXOR; ; ABILIFY; ; CRANBERRY; ; TYLENOL; ; LASIX [FUROSEMIDE]; IPRATROPIUM/ALBUTEROL; ; SENNA [SENNA ALEXANDRINA LEAF]; POLYETHYLENE GLYCOL 3350;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Actual event and cause of death were unknown; This is a spontaneous report from a non-contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID Prevention. The relevant medical history included aortic valve replacement from Nov2019. Concomitant medications were not reported. The consumer stated that she was taking the reporting responsibilities to report that a friend of hers, informed that the patient passed away on Friday, and had received the COVID vaccine on Wednesday. The consumer stated that it was unknown to her at this time, if the friend had called to complete a report herself, regarding the incident. Their conversation was very brief. The patient was 90 years old, and it was her friend's mother that was the patient. Actual event and cause of death were unknown. The patient had her vaccine on Wednesday 06Jan2021, and then the patient collapsed in front of the reporter at Friday night on 08Jan2021 and passed away that same day. The autopsy was unknown. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Actual event and cause of death were unknown

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient was found unresponsive and pronounced dead later that day.

none

unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Death occurred 3 days after vaccine receipt; attributed to complications of her chronic advanced dementia with aspiration at age 87. No evidence of acute vaccine reaction.

aspiration pneumonia- completed treatment prior to vaccination.

Tramadol, risperidone, fluoxetine, cyanocobalamin, colchicine, torsemide, levothyroxine

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall, O2 sats 88-92, dizzy, weakness. Rapid COVID test performed with negative results. Evening of 8th resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice. Continued with fever, crackles and N/V and loss of appetite from the 9th and 10th of January. Resident expired at 820am on 1/11/2021.

No current illness for this event.

Tylenol, tylenol with codeine, Artificial Tears, ASA, Cal-Mag-Zinc, Claritin, Sertraline, Melatonin, MOM, Latuda, Estradiol, Gabapentin, Alendronate, Atorvastatin, Multi-Vit

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Initial pain in back of head and extreme headache. Some vomiting. At emergency, went into coma and was intubated. Hole drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial symptoms.

No current illness for this event.

Losartan, Levothyroxine, Carvedilol

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food, or other products: none. Concomitant medications included unspecified products (List of any other medications the patient received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all these pre-existing medical conditions contribute to the patient death. More information including complete medical history, concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired.

No current illness for this event.

Resident in skilled nursing facility. Please contact facility if needing all medications.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

71yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, VS taken at 10am, B/P 99/60, O2 sats, 95% (trach w/O2). At 11:30am, Patient showed no s/sx of distress, A&Ox3. At 11:50am, a nurse went to perform a COVID test and assessment (the facility is experiencing an outbreak), and found the patient unresponsive on the bathroom floor. CPR was immediately started; no shock advised per AED; 12:15pm EMS arrived and took over. At 12:38pm, EMT called time of death.

UNK

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient reportedly got up in the middle of the night with c/o feeling ""blah"", restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient unresponsive, no pulse, no respirations. GNA notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived and took over. At or around 6:30am, EMT called time of death"

UNK

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

No reactions immediately after vaccine was given. Resident has dementia, has had multiple hospitalizations related to a renal stone recently. Had a tooth that was bothering her, went to see her dentist and it was extracted on 1/6/21. On 1/10 they noted feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not eating. Compassionate visit with family. Family did not want hospice, did not feel it was needed, said, what more could they do for her than you're already doing? On 1/11 at 1950 was determined to be deceased.

Had a tooth extraction done on 1/6/21. Was on amoxicillin for 7 days and it caused diarrhea. Changed to Keflex.

Aspirin 81 mg, metformin, namenda, effexor XR, donepezil, potassium chloride, Vitamin B12, Brillinta, clonzepam, flomax, ultram, oxybutynin chloride, sucralfate, ferrous sulfate, protonix, percocent, metoprolol succinate ER, senna Colace, n

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, and chest. VS:100.2, 113, 20,108/59, 84% room air. applied nasal cannula at 4-L, telephoned Physician orders 6mg Decadron one time order, a second set of Vitals , reads 99.3, 110, 20, 106/60, 90% on 4-L N/C. On coming shift advised. At approximately 2:00am on 1/15/2021, resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately 2:30am PRN cough syrup and breathing tx. Resident's condition began to worsen with breathing tx. This LPN updated at 0248 doctor on resident's condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er called to say resident passed away.

No current illness for this event.

CloZAPine 550 mg QD, Clozaril 150 mg QD, Ergocalciferol Capsule 1.25 MG (50000 UT) QD, MiraLax Powder 17 gram QD, Multivitamin QD, Remeron 45 MG QD, Sertraline HCl 200 mg QD, Simvastatin 20 MG QD, Synthroid Tablet 75 MCG QD, Tricor 14

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

died two days after receiving the vaccine; Fever; This is a spontaneous report from a contactable consumer (patient's stepchild). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 07Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included an unspecified statin. The patient experienced fever on 08Jan2021. The patient died two days after receiving the vaccine on 09Jan2021, which was reported as fatal. The clinical course was reported as follows: The patient had a fever the day after getting the vaccine and then he just died in the middle of night. It was reported that it was not clear what exactly happened, but they are looking into this. The clinical outcome of fever was unknown and of died two days after receiving the vaccine was fatal. The patient died on 09Jan2021. The cause of death was not reported. An autopsy was not performed (was reported to be taking place soon). The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: died two days after receiving the vaccine

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds diminished, loss consciousness and passed away. 01-12-2021

pneumonia,

MANTOUX; ACIDOPHILUS; ALPHA LIPOIC ACID; ASPIRIN EC; BUMETANIDE; C-GEL; ESCITALOPRAM; PROSCAR; KRILL OIL; LEVOTHYROXINE; MAGOX; K-DUR; FLOMAX; VITAMIN B-12; VITAMIN D3; LIORESAL; CALCIUM CITRATE; COCONUT OIL; CURCUMIN; PROAMATINE; PRESERVIS

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient reportedly expired the day following receipt of the vaccine.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"The patient stated "" I just feel Blah"". vital signs obtained. 156/75 p-84 spo2 94% via NC 2L. T-96.7, c/o feeling restless, c/o nausea with no vomiting. Patient observed at 0600 nonresponsive, CPR initiated, and EMS notified Patient expired"

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Veteran was found by family slumped over and unresponsive at the breakfast table on 1/13/21, had expired

No current illness for this event.

Xarelto ,topical lidocaine patch

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient 101 years old, nursing home resident, received vaccine 1/11, on 1/13 found on floor without obvious trauma, unresponsive. Brought to ED and was bradycardic, hypotensive, hypothermic and refractory to aggressive medical management. No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner accepted case although initially unknown that patient had recently received vaccine. ME updated with that information today as soon as discovered.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Pt had witnessed arrest by wife. Pt wife started CPR and called EMS. CPR started at 15:12. Continued by EMS. Pt arrived to medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He was unresponsive to verbal and tactile stimulus and had fixed unreactive pupils. He was pronounced at 16:13.

Chronic systolic heart failure Coronary artery disease involving native coronary artery of native heart without angina pectoris

Hydrochlorothiazide Toprol XL spironolactone prasugrel furosemide Vit D3 albuterol inhaler sildenafil aspirin 81mg Crestor nitroglycerin SL singulair testosterone gel levothyroxine

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Death

Diabetes dementia, cll, trigeminal neuralgia

Ask the nursing home,

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Heart attack death medical test

None

Crestor 20 mg, Claritin-D 24 hour, Zaria 10 mg, baby aspirin, replatha,valsart hits 160-12.5mg Fish oil, wheat germ oil, D3 1000 mg, testosterone 8% gel, CO Q 10, weirder prime , eye drops

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

On 1/17/2021 at 4:35 am resident found apneic and pulseless, at 4:40am death confirmed

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

resident expired; This is a spontaneous report from a contactable healthcare professional. An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia. Known allergies was none. The patient took unspecified concomitant medication. On 11Jan2021, the resident expired. The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021. There was no treatment given for the event. The patient died on 11Jan2021. An autopsy was not performed.; Sender's Comments: Lacking information on the cause of patient's demise, the Company cannot completely exclude a causal relationship between COVID 19 vaccine, BNT162B2, and patient's death of unknown cause, as a cautionary measure and for reporting purposes. The patient's pre-existing medical condition of metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia may have provided the contribution to the event in this 82-year-old male patient. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: resident expired

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia

No current illness for this event.

not provided by facility

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS

NONE

FINASTERIDE 5MG QD, FAMOTIDINE 20 MG DAILY, FOLIC ACID 400 MCG QD, SENNA 8.6 DAILY

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

71 year old woman at rehabilitation center for physical therapy with history of cirrhosis of the liver, asthma, and heart condition was tested for COVID-19 on 01/07/21, received 1st dose of Pfizer COVID-19 vaccine on 01/08/21, positive test result for COVID-19 received on 01/09/21. She was sent to the hospital and admitted on 01/12/21 after O2 was 70% and was in a confused state. Patient passed away on 01/17/21.

Cirrhosis of the liver, asthma, heart condition

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Death

Hip fracture,

Nystatin, vitamin C, Klor Con, Vit B12, Coreg, Lactulose, simethicone, colace, trazodone, multi vitamin, torsemide, miralax, calcium, pantoprazole, breo ellipta,

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Resident received vaccination on January 15, 2021. She was found unresponsive with shallow respirations on the morning of January 16, 2021 and was sent to ER via ambulance. The resident was admitted to medical center ICU where she passed away later that day.

unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Family was told that Patient expired in his sleep during the early morning hours of 1/15. I spoke with him the evening before (on 1/14), which was a day after he had received the Covid vaccine. He was not having any symptoms of allergy or reaction then. He did say that he felt tired, but he often complained of feeling tired over time.

episode of congestive heart failure two months ago requiring hospitalization

Eliquis, losartan, torsemide, metolazone, carvedilol, docusate

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Resident was found deceased in his bed at 7:15 am.

No illnesses at time of vaccination or up to one month prior

Tylenol 500 Mg 2 tabs Bid; Allopurinol 100 Mg Daily; Atorvastatin 40 Mg Hs; Bumetanide 4 Mg Bid; Bupropn 150 Mg Daily; Carvedilol 3.125 Mg Bid; Cinacalcet 30 Mg Daily; Eplerenone 25 Mg Bid; Fluoxetine 40 Mg Daily; Mirtazapine 7.5 Mg Hs; Pan

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021, patient was transferred to Hospital s/p multiple cardiac arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated, but the patient suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021. Ultimately we suspect that the patients condition was a direct result of his underlying disease states, but wanted to make sure reporting was made available.

No current illness for this event.

losartan 100 mg QD, metformin 1000 mg BID, simvastatin 40 mg QD, tamsulosin 0.4 mg QD

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"Narrative: Patient seen in ED 1-17-21 with c/c of ""bloated with epigastric pain"". Patient with complicated medical history including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX), and a leadless permanent pacemaker implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac history: CAD s/p CABG 2009, PAF, and HTN). Regarding ER visit for epigastric pain, nothing notable was found on workup and patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day, and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL, CXR unremarkable for infection, UA neg for bacteria, LFTs WNL, blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting inflammatory response. Patient initially reported feeling better on the morning of 1-19-21, but around 13:00 began rapidly declining (confusion, unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and family is considering autopsy at time of this report."

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Die 50 hours after vaccination; Especially kidney failure; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory authority report number DE-PEI-PEI2021000192. A female patient of 88 years old received bnt162b2 (COMIRNATY, batch/lot number EJ6797, expiration date unknown) , via an unspecified route of administration on 02Jan2021 at single dose for covid-19 immunisation. Medical history included renal failure from Dec2018 to an unknown date , Maxillary sinusitis from 2018 and unknown if ongoing , ongoing reduced general condition , leukoencephalopathy from 2018 and unknown if ongoing , ongoing Weakness, Exsiccosis from 2018 and ongoing , ongoing Dyspnoea, ongoing Chronic anaemia, ongoing renal insufficiency(grade 4), ongoing arthrosis multiple, Ongoing Cardiac disorder, Carcinoma cervix from an unknown date and unknown if ongoing, ongoing Chronic pain, wheelchair dependent. The patient's concomitant medications were not reported. On 04Jan2021, the patient developed die 50 hours after vaccination and especially kidney failure, lasting for unknown. The patient was dead on 04Jan2021. Death cause was reported as die (unknown cause of death). Injection site showed no abnormalities. Patient had Renal insufficiency grade 4. No suspicion of vaccination complication due to disease course and clinical course. General condition deterioration already before vaccination since Christmas, bedridden since 1st day before vaccination, on the day of vaccination lungs were clear, O2 saturation at 97%. Symptoms shortly before death: Dyspnea, weakness, injection site unremarkable. A rapid antigen test was done before vaccination (result: negative). There will be no autopsy, the family decided against it. The patient died on 04Jan2021. Outcome of especially kidney failure was unknown. An autopsy was not performed. Event Assessment was unclassifiable.; Reported Cause(s) of Death: die 50 hours after vaccination.

Arthrosis multiple; Cardiac disorder; Chronic anaemia; Chronic pain; Dyspnoea; Exsiccosis; Reduced general condition; Renal insufficiency (grade 4); Weakness

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

At approximately 930am I arrived at Memory Care. I met with the director of the facility and she directed me to where my team would be setting up. My team consisted of (technician), (nurse) and I. As we were setting up, the director asked how she can help. I explained to her that we would need a designated area for patients to be monitored after vaccination for 15 minutes and maybe even longer . I also explained that we would need one of her staff monitoring while we vaccinate. She agreed, and proceeded to designate her staff and the cafeteria area, facing the vaccination station,the monitoring station. Throughout the day, nurse and I were both vaccinating,while the staff of the facility would monitor the vaccinated patients. I would also stop occasionally to mix the vaccine and check the temperature of the aero safe. At approximately 12:50pm, the director rushed in and stated that a patient is not responding, and that she had been vaccinated. At that point, I grabbed epipens and a thermometer and I also instructed nurse to grab an Epipen and come with me. We followed the director to pt's room. Once we got to the room, the patient was in bed and there were 4 staff members standing bedside and one of them turned and stated the patient has passed. At that point I asked the staff how long ago did the patient get the vaccine, they stated about 30 minutes ago. They also stated that the patient was a hospice patient and that the patient had declined, and was rapidly detiorating and had not eaten or drank anything all day . They also stated that the patient had been monitored for 15 minutes post vaccination. I then left the room and grabbed the patients COVID Vaccine intake consent form. I looked at the answered questionaire and all the responses were circled NO. Patient had a temp of 96.5 at the time of vaccination.The vaccine administration information for Immunizer Section was filled out by Nurse. I then proceeded to ask the director once again if there were staff that was monitoring her for 15 minutes, the director stated they had staff monitoring her. She also stated the Hospice nurse has to announce her death, so they waited for the Hospice Nurse to come. I then called Corporate and explained the situation. After speaking to corporate, I also asked nurse, if she remembered the patient. She stated that she did and at the time of the vaccination the patient was not alert, there were two staff members with the patient. She was non oriented and she kept closing her eyes. At that point, Nurse stated that she asked the two staff members with her if this is how she usually is and if its ok to vaccinate her. Both Staff members stated that it its ok,this is how she is. The Nurse then proceeded to vaccinate. At approximately 3:10pm, as I was leaving I spoke to the director, and one of her Staff members. Staff that the patient has actually not eaten/ or drank anything for the past several days, including today(01/18/21). Staff also stated that on Friday, Jan 15th,2021, they had informed the family that the patient was rapidly detiorating. Staff also stated that the family knowingly gave the consent to vaccinate her. She also stated that the hospice Nurse believes that the death was primarily caused by her detiorating state. She also stated that the hospice Nurse informed that the death was not due to the Vaccine. Per Lead Pharmacist at the clinic.

Patient was a hospice patient who was not doing well for several days per nurse. Patient had not eaten or consumed liquids in a few days.

Unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

This is a 94-year-old male who is brought in by ambulance after being found on the floor with unknown downtime. He was in asystole upon EMS arrival. He remains in asystole. No advanced airway is in place. The patient is getting compressions from Lucas device upon arrival. It was reported that he was last talked to by family at 2 PM. The patient got his SARS-CoV-2 vaccination this morning. The patient is evaluated emergently. CPR was ongoing with 3 rounds of epinephrine given. The patient remains in asystole. He has rigor mortis. The patient's pupils are fixed and dilated. The patient has compressions paused and ultrasound is used to evaluate for cardiac activity. None is detected. The patient has no electrical activity on monitor. The patient's time of death is 2113.

Chronic back pain

Tamsulosin 0.4 mg daily Metoprolol Succinate ER 100 mg daily Rivaroxaban 15 mg daily Levothyroxine 100 mcg daily Furosemide 40 mg daily Atorvastatin 40 mg daily Amiodarone 200 mg daily Nitroglycerin 0.4 mg SL PRN Aspirin 81 mg daily Polyeth

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

1/13/2021 12:00 PM: Patient received COVID-19 Vaccine. 1/14/2021 21:00: Nurse performed routine rounds and the patient appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed, began CPR, and called 911. 1/14/2021 23:08: Pronounced deceased.

None

Acetaminophen 325mg, Aspirin 81mg, Celecoxib 200mg, Docusate Sodium 100mg, Furosemide 40mg, Glimepiride 2mg, Lantus SoloStar 100unit/ml Pen-Injector, NovoLog FlexPen 100 Unit/ml Injection Pen, Senokot 8.6mg, Nu-Iron 150mg, Lisinopril, 20mg,

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

tired; legs felt heavy; stopped breathing; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer. A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 11:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine around 11:00 a.m. About two hours later, he said he was tired and couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon after, he stopped breathing. A nurse declared a do-not-resuscitate order. The patient died on 04Jan2021. It was not reported if an autopsy was performed. Outcome of stopped breathing was fatal. Outcome of tired and legs felt heavy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: stopped breathing

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which ""dissipated after a few minutes"" followed by a headache which ""dissipated after a few minutes"" as well. Then patient complained of nausea, no vomiting and ""couldn't relax."" Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--""he didn't get up to eat."" Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, ""he wasn't responding anymore."" Wife then called 911, ""but they couldn't revive him."""

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Admitted to hospital after vaccination with Acute hypoxemic respiratory failure, Septic shock; Aneurysm of arteriovenous dialysis fistula; expired 1/16/2021

intestinal adhesions with obstruction; Intestinal adhesions with partial obstruction; S/P colon resection; SBO (small bowel obstruction)

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

patient expired 1/15/2021; had been treated as outpatient for pneumonia, likely COVID-19 but no positive test result in December 2020. PMH diabetes

PNEUMONIA

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Admitted 1/14/21: Patient is an elderly 93-year-old female with multiple medical problems including chronic combined CHF, P 80, diabetes mellitus, HTN, hyperlipidemia, CKD stage 3, has been complaining of generalized weakness, fatigue, decreased appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the hospital, condition clinically deteriorated. Patient elected to be DNR/DNI while in the ED. Patient was pronounced dead at 10:30 p.m. earlier today. Preliminary cause of death: Hypoglycemia induced lactic acidosis.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

On Saturday, 1/16/2021, Patient went to the grocery store. Upon her return, she indicated she was experiencing N/V and some throat swelling. Patient subsequently collapsed and expired before she could be brought to an emergency room. During investigation by Coroners Office, it has been reported that Patient may have gotten some takeout food while she was out. Labs are pending and the Coroners investigation is ongoing. Spouse believes that her death was caused by the vaccine.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

presented to ED 1/9/21 with abdominal pain, progressive worsening weakness and fatigue and new onset A fib with RVR likely due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP; progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening clinical decline, palliative care had been consulted on end of life care. Patient expired 1/17/21

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Death, which I believe is unrelated to vaccination

Alzheimers, Covid, COPD, Mood disorder, convulsions, HTN, anxiety, DM, parkinson's,

Oxycodone, ventolin, quetiapine, pantoprazole, metoprolol, lorazepam, haloperidol, senna, levetiracetam

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on 12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was most consistent with an aspiration pneumonia.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Systemic: Vaccine administered 1/15/21, patient passed away on 1/18/21

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient was vaccinated on 01/19/21 using hte Pfizer COVID-19 vaccine. He completed a 30 minute observation team. Later in the day after the vaccination team had already departed the facility, patient had a seizure and passed away.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Possible seizer, unknown at this time, aprox 1hr and 20min after vac given. Passed away aprox 2hrs after vac.

n/A

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Within 15 minutes of the injection, the individual became aphasia and stroke like symptoms. She was taken to the ER where she was later diagnosed with a cerebral hemorrhage and passed away.

None

Bisoprolol 10-62, Fluticasone, Montelukast, Oxybutynin 15mg

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient expired one week after vaccine. Cause of death unknown to me.

No current illness for this event.

Unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

arrested/heart was at a standstill; brief seizure; Last blood glucose was 167; feeling poorly; This is a spontaneous report from a contactable pharmacist. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1283), intramuscularly in the left arm, on 15Jan2021 at 14:00 (at the age of 66-years-old) at a single dose for COVID-19 immunization. Medical history included congestive heart failure presented with unresponsiveness, coronary artery disease, dyslipidemia, hypertension, non-ongoing stroke (no residuals) in 2001, thyroid disorder, walnuts allergies, stenting to left anterior descending artery (LAD) and right coronary artery (RCA), wheezing, chest pain, and erectile dysfunction. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication, taken within two weeks of vaccination, included salbutamol (PROVENTIL) taken for wheezing, salbutamol (VENTOLIN) taken for wheezing, acetylsalicylic acid (ASPIRIN 81), colecalciferol (reported as Vitamin D3; MANUFACTURER UNKNOWN), furosemide (LASIX) taken for weight gain, glyceryl trinitrate (reported as: nitroglycerin; NITROSTAT) taken for chest pain, hydrochlorothiazide (HYDRODIURIL), levothyroxine sodium (SYNTHROID), levothyroxine sodium (LEVOTHROID), metoprolol succinate (TOPROL XL), montelukast sodium (SINGULAIR), prasugrel hydrochloride (EFFIENT), rosuvastatin calcium (CRESTOR), sildenafil (VIAGRA) taken for erectile dysfunction, spironolactone (ALDACTONE), and testosterone (ANDROGEL). It was unknown if patient received other vaccines within four weeks of vaccination. The patient experienced feeling poorly on 15Jan2021 at 14:50 and patient arrested/heart was at a standstill, brief seizure, and last blood glucose was 167 on 15Jan2021 at 15:15. The patient expired on 15Jan2021 at 15:15. The clinical course was reported as follows: The patient received the vaccine on 15Jan2021 around 14:00 and started feeling poorly around 14:50. The patient arrested after a brief seizure. Cardiopulmonary resuscitation (CPR) was initiated by his wife. Emergency medical service (EMS) arrived around 15:21 and initiated advanced cardiovascular life support (ACLS). CPR was continued upon arrival. A bedside ultrasound was performed and revealed his heart was at a standstill on 15Jan2021 and last blood glucose was 167 on 15Jan2021. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of expired and arrested/heart was at a standstill was fatal and of feeling poorly, brief seizure, and last blood glucose was 167 was not recovered. The patient died on 15Jan2021. The cause of death was assessed as arrested/heart was at a standstill. It was not reported if an autopsy was performed. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The 66-year-old male patient had medical history included congestive heart failure presented with unresponsiveness, coronary artery disease, dyslipidemia, hypertension, stroke, thyroid disorder, stenting to left anterior descending artery (LAD) and right coronary artery (RCA), wheezing, chest pain. The reported fatal event cardiac arrest was most likely due to concurrent cardiac diseases, and unlikely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: arrested/heart was at a standstill

No current illness for this event.

PROVENTIL [SALBUTAMOL]; VENTOLIN [SALBUTAMOL]; ASPIRIN 81; ; LASIX [FUROSEMIDE]; NITROSTAT; HYDRODIURIL; SYNTHROID; LEVOTHROID; TOPROL XL; SINGULAIR; EFFIENT; CRESTOR; VIAGRA [SILDENAFIL]; ALDACTONE [SPIRONOLACTONE]; ANDROGEL

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

At approximately 12:15 pm the resident had a brief unresponsive episode that resolved quickly. Her Vital signs were stable and her mentation was at baseline. Later that evening approximately 10 pm she had labored respirations, shortness of breath, lethargy with bilateral crackles, Oxygen desaturated to 76% on room air, tachycardia and hypotension. She expired at 6:30 a.m. the following day.

Admitted from home to hospital on 1/5 for pancreatitis, Chocystitis, GI bleed. HAd a biliary stent placed. TEsted positive for Covid 19 on 1/7/21. Transferred from hospital to a covid recovery Short term facility and transferred to this facility on 1/18/21 for long term care. She was admitted on comfort measures due to prior decline

VEntolin inhaler, Ursodial, Protonix, MVI, Mirtazapine, Lasix, Coumadin

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"Unspecified event/he passed away; Dizziness; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3302), intramuscular at single dose in the left arm on 20Jan2021 08:15AM for Covid-19 immunisation. Medical history included atrial fibrillation (Diagnosed about 10 years ago). Concomitant medications included unspecified drug for atrial fibrillation. On 20Jan2021, the patient experienced dizziness, nausea, headache with outcome of unknown and unspecified event/he passed away. The patient died on 20Jan2021. An autopsy was not performed. The events were described as follows: ""Her husband received the first dose of the vaccine yesterday morning and he passed away last night. She is not sure what time he died last night. States he was so eager to get the vaccine. Reports he was exhibiting symptoms that were listed as possible side effects. He was experiencing dizziness, nausea, and a headache that started several hours after the vaccine, the side effects started in the early afternoon. She does not know the cause of death and does not think an autopsy was performed"". The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Reported Cause(s) of Death: Unspecified event/he passed away"

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Reportedly, this employee's mother died the night of the vaccine. The details are not known at this time.

Diabetes Mellitus

Diabetes Prescription

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Resident expired on 1/23/21 . Resident receiving care under hospice ,diagnosis Acute Myeloid Leukemia.

Acute Myeloid Leukemia

Amlodipine 2.5 mg Eliquis 2.5mg Aspirin 81 mg Cholecalciferol 1.25 mg Ondansetron 4mg , Thiamine HCL 100, Inrebic 100mg Oral Capsule

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Systemic: Other- unknown, depot store received call from facility on 1/22 that patient passed around 7pm

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Resident passed away 1/25/2021 at 1048pm after the vaccine was given on 1/24/2021. Resident had been being monitored but death was not expected.

COVID-19 diagnosis 12/29/2020, pneumonia, CHF, depression, rheumatoid arthritis and anemia.

guaiFENesin, aspirin, celexa, Buprenorphine, zinc, vitamin D, voltaren gel, miralax, hydralazine, ascorbic acid, coreg, tramadol, metolazone, melatonin, potassium, gabapentin, senna, magnesium, ocuvite, losartan potassium, doss, vitamin B1

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient developed fever to 102 within 24 hours with decreased mentation. Stopped eating/drinking despite aggressively treating fever. Was DNR B status. Family agreed to a trial of IV fluids on 1/21 but was not successfully started until 1/22 after several attempts. Family wanted only comfort measures with no transfer to hospital. Patient continued to have fevers to 102-103 range. Patient passed on 1/23 . Patient did test positive for COVID in early September without significant illness. She was in usual state of health prior to vaccination.

none

depakote, seroquel, aspirin, loratidine, prilosec, senna plus, vitamin D, gabapentin

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

No immediate symptoms. No symptoms ever reported. Patient was found dead in her home on 1/25/2021 and last seen on 1/24/2021. Neighbor called for welfare check because they had not seen her and she had not checked mailbox. No evidence of foul play.

Asthma, COPD exacerbation.

Ipratropium and prednisone prescribed on 1/6/2021. Other medications include albuterol inhaler & nebulizer solution, calcium carbonate, cetirizine, cyclobenzaprine, fluticasone nasal spray, Advair HFA, home oxygen, guaifenesin, lidocaine 5

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHIBITED ANY SYMPTOMS. RESIDENT WAS OBSERVED TO BE UNRESPONSIVE WITH NO PRESENCE OF VITAL SIGNS ON 1/24/2021. RESIDENT WAS A FULL CODE, CPR INITIATED UNSUCESSFULLY. BASED ON REVIEW WITH PRIMARY CARE PHYSICIAN AND MEDICAL DIRECTOR, THE RESIDENT HAD NOT HAVE ANY OTHER EVENTS PRIOR TO RECEIVING THE COVID VACCINE 4 DAYS PRIOR TO EVENT.

No current illness for this event.

MOBIC, MVI, OLANZAPINE, REMERON, COLACE, TYLENOL

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

decedent had shortness of breath and hypoxia, cardiac arrested in front of the EMS crew, ACLS initiated, arrived in the Hospital ED asystole and pronounced dead

hypothyroid, hypertension

pantoprazole, levothyroxine, lisinopril, lamotrigine, atenolol, mirtazapine, furosemide, dronabinol

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

The patient had a heart attack and died at a local hospital morning of 1/19/2021.

none

Unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Systemic: Headache-Severe, Systemic: Other- Death 8 days after receiving the vaccine-Severe

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises, with some compliance, continues ABT/pneumonia , no s/s adverse 1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000.

Anemia, Dementia, COPD

Acetaminophen Tablet 325 MG Give 2 tablet by mouth every 4 hou

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"vomiting x3 1/8/21 1/9/21 00:34 - called to resident room by CNAs, staff stated resident was ""different"". Vitals taken and 02 sat was low, O2 in room and applied via NC @3L, O2 sat returned to 98 and all other vitals WNL including BS. Resident asked how he felt, stated he felt ""okay"". Resident exhibiting some shakey movements and clearing throat, states he does not have any phlegm or drainage or trouble swallowing. MD called and updated on situation, voicemail left. 1/9/21 11am- resident has been making a ""growling"" noise this shift. resident also has tremors. resident alert and answers questions appropriately. when asked if resident wants to go to hospital, resident firmly states ""no"". vitals wnl. no emesis noted. will continue to monitor resident. 1/9/21 12p- resident not answering questions appropriately. resident only answering yes or no. resident cannot tell me name, or the year, resident cannot state where he is currently or birthdate."

OTHER INJURY OF UNSPECIFIED BODY REGION, SUBSEQUENT ENCOUNTER , LOCAL INFECTION OF THE SKIN AND SUBCUTANEOUS TISSUE, UNSPECIFIED , CELLULITIS OF LEFT LOWER LIMB, CELLULITIS OF RIGHT LOWER LIMB , END STAGE RENAL DISEASE , DEPENDENCE ON RENAL DIALYSIS , TYPE 2 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE,UNSTEADINESS ON FEET , CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH (ACUTE) EXACERBATION, DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED , MUSCLE WASTING AND ATROPHY, NOT ELSEWHERE CLASSIFIED, UNSPECIFIED SITE , COGNITIVE COMMUNICATION DEFICIT, REPEATED FALLS, OTHER LACK OF COORDINATION, SPINAL STENOSIS, LUMBAR REGION WITH NEUROGENIC CLAUDICATION, ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS,

Renvela, Clopidogrel, Coreg, Aceteminophen, amLODIPine Besylate, Atorvastatin Calcium, Benzonatate, Calcium Acetate, Citalopram Hydrobromide, cloNIDine, Cozaar, Diclofenac, Docusate Sodium, Fluticasone-Umeclidin-Vilant Aerosol Powder Breath

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

See initial report

The resident was febrile on 1/9/2021 after receiving the Pfizer vaccine on 1/7/2021. On 1/9/2021 UA, CBC, and CMP ordered indicating she had UTI. SARS-CoV-2 testing was performed using POCT GeneXpert on 1/9/2021. No SARS-CoV-2 was detected. The resident continued to decline and on 1/15/2021 she became tachycardiac and was having trouble breathing. She was transferred to ER where she later died.

Atorvastatin Calcium 10mg, Ceftriaxone 1GM, Famotidine, Hydrocodone-Acetaminophen 5-325mg, Levothyroxine 25mcg, Senna, ASA, Docusate

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Narrative:

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient stated he wasn't feeling well on January 25, 2021, wasn't eating and complained of abdominal pain. Patient noted to have indigestion and was constipated. Meds provided and labs ordered. On morning of January 26, 2021, patient became weak, lethargic and hypoxic and was sent to emergency department around 0700 hours on January 26, 2021. At approximately 1100 hours, emergency physician notified this writer that patient was not going to overcome his illness and would be placed on comfort care. At approximately 1130 hours, this writer was notified that patient had passed away from multi-organ failure.

CHF exacerbation in November 2020

Acetaminophen, Aspirin, Sinemet, Docusate, Eliquis, Finasteride, Fluticasone, Furosemide, Klor-con, Melatonin, Nortriptyline, Pantoprazole, Simvastatin, EMU muscle and joint relief cream, Synthroid, Tamsulosin, Vitamin B12, Vitamin D3, TUMS

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

"CC:full arrest HPI:HPI and ROS limited due to patient's condition. History is via EMS, medical record, and son. Per Son patient had Covid vaccine on Saturday morning. Slept all day Sunday. Woke up Sunday night a bit ""like coming out of a deep sleep per son, around 10 pm. Shortly after that patient was having a hard time breathing. Emergency called. Arrested around the time EMS arrived. King airway, I/O and CPR initiated. Patient has been in v fib. Was shocked multiple times, given 4 rounds of epi, bicarb and amiodarone. ACLS continued on arrival. Multiple rounds of epi, and attempted defib. Patient given epi, bicarb. Rhythms included fine v fib, asystole, and PEA. Unrecoverable with no cardiac motion. Time of death 11:50 pm."

Pt admitted with closed-loop bowel obstruction with subsequent surgery for ex-lap, SBR ~160cm jejunem and ileum, left with open abdomen with Abthera wound vac 12/22. Now s/p Exploratory laparotomy, primary stapled small bowel anastomosis, abdominal fascial and skin closure on 12/24.

warfarin (COUMADIN) 2.5 mg tablet zinc sulfate 220 (50) mg capsule nutritional supplements (NUTREN 1.5) 0.07 gram-1.5 kcal/mL liqd acetaminophen (TYLENOL) 325 mg tablet senna (SENOKOT) 8.6 mg tab furosemide (LASIX) 40 mg tablet spironolacto

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

(Report per patients wife ) Patient took his usual nap around 12pm. She found him lying in the bed unresponsvie at 2pm. EMS was not called. Patient's wife called the Funeral home.

Unknown

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

No symptoms appeared immediately after vaccination, although patient passed away around 6:00 pm unexpectedly. Staff talked with her last time at 5:30 pm and then found her at 6:00 pm passed away. Unknown at this time if death is directly related to receiving the vaccine.

Hospice client Some diarrhea with colostomy bag in place general decline

B12 vitamin 1 tab po daily Triamcinolone acetonide cream 0.5% apply 2-3 times per day Tylenol 500 mg as needed- Had not taken at all in January Loperamide 2 mg as needed-Had not taken at all in January

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

died suddenly at night; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 15Jan2021 (at the age of 72-years-old) as single dose for COVID-19 immunization. Medical history included myasthenia gravis, hypertension (well controlled), non-ongoing major back surgery on an unspecified date (4 months ago), and deep vein thromboses (DVTs) (cleared by ultrasound after therapy). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included pyridostigmine bromide (MESTINON), prednisone (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), hydrochlorothiazide, lisinopril (MANUFACTURER UNKNOWN), and rivaroxaban (XARELTO). The patient died suddenly at night on 21Jan2021 at 02:00. It was reported that the patient was not sick or showing any symptoms before bed on 20Jan2021 at 21:00 and reported feeling fine after getting the vaccine. The patient did not receive any treatment for the event. The patient died on 21Jan2021. The cause of death was unknown. An autopsy was not performed. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.; Reported Cause(s) of Death: died suddenly at night

No current illness for this event.

MESTINON; PREDNISONE; TRAMADOL; TYLENOL; LISINOPRIL/HCTZ; XARELTO

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Presented with stroke like symptoms at 10:30, right sided weakness and slurred speach. 911 was call, patient was transported to hospital. Per ED note, patient experienced TIA which resolved, actue exacerbation of CHF. Patient was admitted. Discharge summary on 1/22 indicates same diagnosis, plan was home with hospice. Family notified hospital on 1/25 that patient had expired on 1/23 at home.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient received COVID 19 vaccine the morning of 1/18/21 at Public Health COVID-19 vaccine clinic. I (person completing this report) work for PH. Later that night while in bed, patient reported difficulty breathing to his wife, then turned blue, and became unresponsive. Family report pt was without any symptoms prior to event. 911 called; CPR started by family member 15 min. after pt became unresponsive. EMS performed resuscitation for about 30-40 minutes with multiple defibrillation for V-fib. Between EMS and Medical Center ER, pt had 9 rounds of epi, CPR w/ LUCAS machine, given 2 doses of amiodarone (150 mg and 300 mg). Patient had 3 EKGs, which did not show STEMI, but did show nonspecific conduction delay and sinus arrest with junctional escape vs sinus bradycardia (HR 50's). Pt had return of spontaneous circulation. Pt intubated, and started on Levophed. Pt transferred to ICU, and had central line placed. Family decided to make patient DNR. Pt went into coarse VFib again, and as per wishes of family, code blue not called. Patient expired at 01:53 on 1/19/21.

unknown; family report pt without symptoms prior to event

per hospital list: Nitrostat 0.4 mg SL prn, famotidine 10 mg, ASA 81 mg, atorvastatin 20 mg, benazepril 5 mg, carvedilol dose unspecified

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient arrived at ER with complaints of CPR in progress. Per EMS, patient became short of breath while performing yard work on 1/26/2021. At arrival, patient was in fine v fib with a total of 6 shocks delivered along with 300 mg amiodarone followed by 150 mg amiodarone, 1 amp epinephrine and 2 epinephrine drips adminstered en route to ED. CPR initiated at 1755 and EMS reports asystole at 1829. TOD 1909 pronounced by ED DO Dx: Cardiac arrest

Malignant neoplasm of colon dx Stage IIB in 2018. Surgery in 2018 to remove mass Inguinal hernia (rt) CT follow up in 12/2020 r/t above found no evidence of metastatic disease in abdomen or pelvis, inguinal hernia still present. Distension in abdomen reported in 11/2020 through 12/2020 at office visit

Adult one daily multivitamin Vitamin B12 Vitamin D Acetaminophen - Codeine 300-30 prn acyclovir levothyroxine

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Per EMS, the patient was last seen walking and talking to wife 10 minutes prior to EMS arrival. EMS reports via patients wife, that patient was upstairs to change for his doctor appointment then patient's wife found him down. The patient received his COVID-19 vaccine on 1/25/21. EMS states they gave 5 rounds of EPI then patient moved into vfib then was shocked once but returned to asystole. In ED, the patient initially in asystole CPR was started immediately. The patient was given 3 rounds EPI, 1 round bicarb. The patient stayed in PEA throughout. Patient was given tPA. Patient continued to be in asystole and time of death was called at 11:35 am.

History of benign prostatic hyperplasia, hypertension, urinary tract infection, cerebrovascular accident. 1/25/21 Brought to Hospital ED by EMS from Health District for near syncope and hypotension post Pfizer vaccine administration. 1/27/21 Brought to Hospital ED by EMS from home after wife found.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

Patient noted to have a change in status at 11:23PM that night. Her oxygen saturation had dropped from normal on room air to 82% and required oxygen. She was also noted to be lethargic with altered mental status and not responding verbally. She then began to mottle. Her oxygen saturation worsened to 51% on 4Liters of oxygen by the next day and she expired on 1/14/21.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Jan., 2021

per daughter pt suffered a stroke 1 hour after he was given the covid vaccination. he passed away on 01/24/2021.

No current illness for this event.

Acetaminophen (TYLENOL) 500 mg Tablet Atorvastatin (LIPITOR) 80 mg tablet Blood Sugar Diagnostic (FREESTYLE LITE STRIPS) Strips Clopidogrel (PLAVIX) 75 mg Tablet cyanocobalamin, vitamin B-12, 2,500 mcg Tablet DULCOLAX, BISACODYL, PO Ezetimi

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Unknown Date

"Narrative: Was pt previously covid positive?- Yes. Initial- 10/27/2020, 11/29/2020, 12/22/2020 Are there any predisposing factors for patient experiencing adverse drug event?- Yes, patient had multiple co-morbidities including GI bleed, hepatitis congestion due to cardiac issues, treatment for PE, NSTEMI, or antibiotics for PNA, also on concurrent medications APAP, Atorvastatin, Mirtazapine and Duloxetine. Pt with 2 doses of covid-19 vaccine, second one on 01/08/2021, 2 days pre-death Any occurrence of an ADR at time of administration? Did not specify injection site issues, per RN admin note- Vaccine ""administered without complications."" Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation period and date of death? No Did patient recover from event? No (01/08/2021 event, died 01/10/2021) Was patient hospitalized prior to vaccination? Yes, in between inpatient and nursing home Was patient hospitalized prior to death--was hospitalization attributable to ADE? Yes re-admitted to inpatient on 12/31/2020. GI bleed Is there an alternative cause of death? Yes, as noted above. Quite a complicated case with many comorbidities/concurrent medications as noted above. Primary Diagnosis: Upper GI Bleed in the death note from 01/10/2021"

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

65+ years

Unknown Date

Death on 21 Jan 2021 - coroner called provider office

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Asystole; Circulatory collapse; This is a spontaneous report from a contactable pharmacist received from Agency and downloaded from the Regulatory Authority-WEB GB-MHRA-WEBCOVID-20201214111558, Safety Report Unique Identifier GB-MHRA-ADR 24542972 and EU-EC-10007191566 received via Regulatory Authority. An adult female patient received bnt162b2 (batch/lot number not provided), via an unspecified route of administration on 13Dec2020 at single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medication included sildenafil, acetylsalicylic acid, allopurinol, levothyroxine, spironolactone, amiloride hydrochloride, furosemide and desogestrel. The patient experienced asystole on 13Dec2020, circulatory collapse on 13Dec2020. The patient died due to asystole and circulatory collapse on 13Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about batch number is not obtainable. No further information is expected.; Reported Cause(s) of Death: circulatory collapse; Asystole

No current illness for this event.

; ; ; ; ; ; ;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

found dead in his bed; This is a spontaneous report from a contactable healthcare professional received via the Ministry of Health department of epidemiology. The department of epidemiology reported similar events for two patients. This is the second of two reports. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK4175), via an unspecified route of administration on 24Dec2020 as a single dose for COVID-19 immunization. Medical history included schizophrenia, very heavy smoker for almost 50 years, emphysema, and tumor resection in the bladder. The patient's concomitant medications were not reported. On 28Dec2020, the patient was found dead in his bed. It was reported that the patient did not have any complaints in the days following the vaccination. Then, on 28Dec2020, the patient was found dead. The cause of death was unknown. It was not reported if an autopsy was performed.; Sender's Comments: A reasonable possibility that the event unknown cause of death is related to vaccination with BNT162B2 cannot be completely excluded until further information regarding clinical course and death cause is provided. Of note, the patient did not have any complaints in the days following the vaccination. The case was confounded by the patient's underlying conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 same reporter, same vaccine, reporting similar events in different patients.; Reported Cause(s) of Death: found dead in his bed

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Sudden death; This is a spontaneous report from a contactable physician and consumer. A 41-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on 30Dec2020 at 0.3 mL single dose for COVID-19 immunisation. Medical history included hypertension. The patient's concomitant medications were not reported. On 01Jan2021, the patient experienced sudden death. The clinical course was as follows: The patient didn't experience any adverse event at the moment of inoculation with COVID-19 vaccine or the following days. On 01Jan2021, at lunch time, two days after receiving the vaccine, the patient was found unresponsive in her bed by her partner. The cause of death was unknown. It was reported that an autopsy would be performed in the next days; the results were not yet available. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported information is limited and does not allow a meaningful assessment of the case. It will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

cardiac arrest; This is a spontaneous report from a contactable physician. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization. Medical history included asthma and a little overweight from an unknown date. The patient's concomitant medications were not reported. The patient experienced cardiac arrest on an unspecified date, which was serious as it lead to death. The patient died on an unspecified date. It was not reported if an autopsy was performed. This batch/lot number is not available despite the follow-up attempts made. No further information is expected.; Sender's Comments: The reported information is limited and does not allow a meaningful assessment of the case. It will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: cardiac arrest

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Atrial fibrillation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is GB-MHRA-EYC 00236011. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0553), intramuscular on 18Dec2020 at 0.3 mL, single for covid-19 immunization. Medical history included ongoing hypothyroidism, ongoing diabetes, ongoing atrial fibrillation, ongoing frailty and, ongoing osteoporosis, all from unknown dates. Concomitant medication included prednisolone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), salbutamol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN). The patient experienced atrial fibrillation on an unspecified date, which was serious as it was medically significant, involved hospitalization and lead to death. Clinical course was as follows: the patient was vaccinated. Consent was obtained and a pre immunization checklist was completed. She was observed following the administration of the vaccine, and no adverse effects were noted. She returned home. She became unwell and was admitted to hospital approximately 24 hours later. The patient was admitted to the hospital 24 hours following the vaccination, and subsequently died later, while in the hospital. The full clinical details were unknown, but the diagnosis from Accident & Emergency was atrial fibrillation. It is not clear if this had any relation to the vaccine that was administered, but could not be excluded, per the reporter. The patient died on 20Dec2020. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Atrial fibrillation

Atrial fibrillation; Diabetes; Frailty; Hypothyroidism; Osteoporosis

; ; ; ;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Death; Loose stools; Vomited; This is a spontaneous report from a contactable other healthcare professional by Pfizer from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20201230164020. An elderly female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Batch: EJ1677, Expiration date: Feb2021) via an unspecified route on 29Dec2020 at single dose for Covid-19 vaccination. Medical history included dementia and a history of urinary tract infection and delirium, all from an unknown date and unknown of ongoing. Concomitant medication included influenza vaccine (INFLUENZA VIRUS, Batch: 4924B1A) for influenza immunization. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. No known allergies. The patient had not tested positive for COVID-19 since having the vaccine. On the 29Dec2020 the patient experienced loose stools and vomited. The patient underwent lab tests and procedures which included COVID-19 virus test: no -negative on 08Dec2020. The patient died on the 30Dec2020 at 11:25 am in the morning. It was unknown if a postmortem was going to be carried out, after talking to the general practice surgery they advised that the general practitioner was only passed notification of the patient's death that afternoon (04Jan2021). It was advised that they may go to the coroner but couldn't give a definitive answer until the general practitioner had looked at the notification. It was not reported if an autopsy was performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death

No current illness for this event.

INFLUENZA VIRUS

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

At night they found him lifeless. Probably following acute MI; pain in the arm and swelling in the arm of vaccination; pain in the arm and swelling in the arm of vaccination; This is a spontaneous report from a contactable other healthcare professional via Division of Health. The other healthcare professional reported similar events for three patients. This is the second of three reports. A male patient of an unspecified age received BNT162B2 (lot# EK4175), via an unspecified route of administration on 25Dec2020 at single dose for Covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) with smoking background, atrial fibrillation, aortic stenosis, diabetes with damage to all target organs (nephropathy, retinopathy, neuropathy), carotid stenosis, deep vein thrombosis (DVT) history, history of alcohol use with hepatitis, history of Hodgkin's lymphoma after successful chemotherapy treatment, got around on a scooter. The patient's concomitant medications were not reported. The patient was vaccinated on 25Dec2020 and passed away at home on 28Dec2020. Before his death, according to his daughter, he complained about pain in the arm and swelling in the arm of vaccination on an unspecified date of Dec2020. At night they found him lifeless. Probably following acute myocardial infarction (MI). The outcome of pain in the arm and swelling in the arm of vaccination was unknown, acute MI was fatal. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Fatal acute myocardial infarction is more likely attributed to the patient underlying medical conditions including vascular stenosis and diabetes with complications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : IL-PFIZER INC-2020519349 same reporter/product, similar event, different patient;IL-PFIZER INC-2021009752 same reporter/product, similar event, different patient; Reported Cause(s) of Death: acute MI

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

SEPSIS; respiratory distress; PLEURAL EFFUSION; This is a spontaneous report received from other healthcare professional via the Division of epidemiology of the Ministry of Health. The other healthcare professional reported similar events for three patients. This is the third of three reports. A 91-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included known background of blood pressure disease, diabetes, malignant bladder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was received at the emergency room 3 days after receiving the corona vaccine in Jan2021, with fever, vomiting more than 40 times, in respiratory distress, was hospitalized in internal medicine department with sepsis diagnosis due to respiratory distress and pleural effusion, intubated, his condition was serious, patient passed away on 04Jan2021. Cause of death was reported as sepsis, respiratory distress and pleural effusion. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected. Information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information currently provided, the fatal events sepsis, respiratory distress and pleural effusion are more likely attributed to intercurrent infectious conditions associated with the advanced old patient underlying diseases . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020519349 same reporter, product, similar event, different patient;IL-PFIZER INC-2021009751 same reporter, product, similar event, different patient; Reported Cause(s) of Death: SEPSIS; respiratory distress; PLEURAL EFFUSION

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Death within 24 hours after dose; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority (GB-MHRA-EYC 00236003 and GB-MHRA-ADR 24545815). A 78-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 20Dec2020 at 16:00 as a single dose for COVID-19 immunization. Medical history included cardiac disease and lung disease. The patient had no known allergies. Concomitant medications included an unspecified hypertensive taken for hypertension, an unspecified drug for ischaemic heart disease, and an unspecified drug for chronic obstructive pulmonary disease (COPD). The patient experienced death within 24 hours after dose on 21Dec2020. The event was reported as fatal. The clinical course was reported as follows: The patient was observed for 15 minutes after the dose was given and had no side effects. In the evening, the patient felt well. The patient received the vaccination as he was a high risk patient, elderly, and with a background of cardiac and lung disease. The clinical outcome of death within 24 hours after dose was fatal. The patient died on 21Dec2020. The cause of death was unexplained. It was unknown if an autopsy was performed. The reporter assessed the causality between the vaccination and death as unlikely. No follow-up attempts possible; information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Death unexplained

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Death; Head ache and dizziness; Head ache and dizziness; Spitting blood; Vomiting blood; Nose bleed; This is a spontaneous report a contactable consumer downloaded from the Regulatory Authority(GB-MHRA-WEBCOVID-20201220100831 and GB-MHRA-ADR 24545199). A male patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 17Dec2020 as a single dose for COVID-19 immunisation. Medical history included vitamin D3 deficiency and asthma. Concomitant medications included colecalciferol (MANUFACTURER UNKNOWN) for vitamin deficiency and salbutamol sulfate (VENTOLINE) for asthma. The patient experienced nose bleed on 17Dec2020, head ache and dizziness, spitting blood, and vomiting blood on 18Dec2020, and death on 20Dec2020. All of the events were reported as fatal. It was reported that a healthcare professional advised the patient to take unspecified pain medication after explaining mild and strong side effects to help with pain. The patient underwent lab tests and procedures which included COVID-19 virus test: No - negative COVID-19 test on an unspecified date. Therapeutic measures were taken as a result of nose bleed, head ache and dizziness, spitting blood, and vomiting blood as aforementioned. The clinical outcome of nose bleed, head ache and dizziness, spitting blood, vomiting blood, and death was fatal. The patient died on 20Dec2020. The cause of death was unexplained. It was not reported if an autopsy was performed. It was also reported that since the vaccination, the patient had not been tested positive for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death unexplained

No current illness for this event.

; VENTOLINE [SALBUTAMOL SULFATE]

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

patient died after collapsing in his home several hours after he received the vaccine; patient died after collapsing in his home several hours after he received the vaccine; The initial case was missing the following minimum criteria: the reporter does not have first-hand knowledge of the reported events and was not identifiable. Upon receipt of follow-up information on 06Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional via regulatory Authority. The regulatory authority reported similar events for three patients. This is the first of three reports. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK4237), via an unspecified route of administration on 28Dec2020 as a single dose for COVID-19 immunization. Medical history included dementia, cardiac background with pacemaker, atrial fibrillation, heart failure, and penicillin allergy. The patient was not allergic to polyethylene glycol. The patient's concomitant medications were not reported. On 29Dec2020, the patient died after collapsing in his home several hours after he received the vaccine. Outcome of collapsing was not recovered. The patient had no pulse when he arrived at the hospital. It was not reported if an autopsy was performed. The cause of death was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: The advance old patient had underlying cardiac background with pacemaker, atrial fibrillation and heart failure, therefore the pre-existing cardiovascular medical conditions more likely provide explanations for collapsing lead to the patient death. More information especially death cause and autopsy results are needed for further meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2021009752 same reporter, product, similar event, different patient;IL-PFIZER INC-2021009751 same reporter, product, similar event, different patient; Reported Cause(s) of Death: Unknown cause of death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Hypoxic respiratory failure; Dyspnea exacerbated; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB DK-DKMA-WBS-0028232. The report was received from a contactable physician via The Medicines Agency (MA). A 45-year-old male patient received BNT162B2 (COMIRNATY) (Lot #: EJ6797, Expiration Date: 30Apr2021), via intramuscular on 30Dec2020 at single dose for Covid-19 vaccination. Medical history included ongoing treatment noncompliance, ongoing alcohol abuse chronic, ongoing psychosis, dyspnoea from 20Dec2020 and ongoing, ongoing hallucination, ongoing tobacco abuse, ongoing paranoid schizophrenia, chronic obstructive airways disease exacerbated from Aug2020 and ongoing, chronic obstructive airways disease exacerbated from Nov2020 to an unknown date (not ongoing), hypoxic down to 60 % from 20Dec2020 and ongoing, Amphetamine abuse (not ongoing), ongoing pain, ongoing opioid abuse, ongoing anxiety, and ongoing insomnia. There is no information regarding past medication. Concomitant medication included prednisolone (PREDNISOLON ACTAVIS) from 20Nov2020 for Chronic obstructive airways disease, ipratropium bromide, salbutamol sulfate (IPRAMOL) from 20Nov2020 for Chronic obstructive airways disease exacerbated, orphenadrine hydrochloride (LYSANTIN) from 02Dec2019 to 03Jan2021 for Anxiety aggravated, quetiapine fumarate (QUETIAPIN ACCORD) from 16Dec2020 to 03Jan2021 for Psychiatric symptom, salbutamol sulfate (VENTOLINE) from 03Nov2018 for Chronic obstruct airways disease, paracetamol (PARACETAMOL ORIFARM) from 30Nov2020 to 03Jan2021 for Pain, quetiapine fumarate (QUETIAPIN ARROW) from 15Aug2020 to 03Jan2021 for Psychiatric symptom, buprenorphine hydrochloride, naloxone hydrochloride (BUPRENORPHINE/NALOXONE MYLAN) from 29Jun2020 to 03Jan2021 for Opioid abuse, paliperidone palmitate (XEPLION) from 19Dec2019 to 03Jan2021 for Psychiatric disorder prophylaxis, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA) from 04Jul2019 to Jul2019 for Chronic obstruct airways disease, promethazine hydrochloride (PHENERGAN) from 24Sep2020 to 03Jan2021 for Insomnia. The patient experienced hypoxic respiratory failure on 31Dec2020, dyspnea exacerbated on 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac arrest or respiratory treatment in the event of respiratory failure. Initially the patient did not want to transfer to somatic treatment. But because of anxiety after dyspnoea the patient got treatment with oxygen. On 01Jan2021 the patient denied again treatment despite clear indication for oxygen therapy and COPD exacerbations treatment with ipratropium bromide and salbutamol sulfate (IPRAMOL) and inhalations. On 02Jan2021 the patient received oxygen-treatment, but the patient did not want further somatic treatment. It was stated in the patient journal that the patient did not want treatment and that in the given situation there was nothing more to do. Therefore the patient was returned to department with palliative treatment in the form of oxygen, midazolam subcutaneous (S.C.) and morphine S.C. On the 03Jan2021 the patient's respiration was calm. The patient was unreachable. At 14:00 he was restless and got palliative treatment with midazolam and morphine. The patient underwent lab tests and procedures which included c-reactive protein: normal on an unspecified date, 16 on 27Dec2020, fibrin D dimer: normal on 31Dec2020, fluid balance assessment: normal on 27Dec2020, forced expiratory volume (FEV 1): 37 % on 2018, hepatic enzyme: normal on 27Dec2020, oxygen saturation: 64 % on an unspecified date, 60 % on 20Dec2020, 58 % on 27Dec2020, 62 % on 31Dec2020, 35 % (in the ambulance) on 31Dec2020, 100 % (on oxygen-treatment) on 31Dec2020, 40-60% on 02Jan2021 12:47 pm, 58 % (in the ambulance) on 02Jan2021 09:00 am, 30 % on 02Jan2021 04:24 am, 99 % (on oxygen-treatment) on 02Jan2021, PCO2 up to 12.8 (Unit not specified) on an unspecified date, PO2 Down to 4.8 (Unit not specified) on an unspecified date. The patient died on 03Jan2021. An autopsy was not performed. The outcome of the events was fatal. Causality: The reporter assessed that even though the patient's symptoms have occurred long before the vaccination, it can not be ruled out that the patient's dyspnoea and hypoxia due to COPD have been aggravated by the vaccine. If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted.; Reported Cause(s) of Death: Dyspnea exacerbated; Hypoxic respiratory failure

Alcohol abuse chronic; Anxiety; Chronic obstructive airways disease exacerbated; Dyspnoea; Hallucination; Hypoxic (Hypoxic down to 60 %); Insomnia; Opioid abuse; Pain; Paranoid schizophrenia; Psychosis; Tobacco abuse; Treatment noncompliance

PREDNISOLON ACTAVIS; IPRAMOL; LYSANTIN; QUETIAPIN ACCORD; VENTOLINE [SALBUTAMOL SULFATE]; PARACETAMOL ORIFARM; QUETIAPIN ARROW; BUPRENORPHINE/NALOXONE MYLAN; XEPLION; TRELEGY ELLIPTA; PHENERGAN [PROMETHAZINE HYDROCHLORIDE]

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Sepsis; Acute bronchopneumonia; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (GB-MHRA-EYC 00236063 and GB-MHRA-ADR 24546059). An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 15Dec2020 as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included pregabalin (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), candesartan (MANUFACTURER UNKNOWN), and levothyroxine (MANUFACTURER UNKNOWN). The patient experienced acute bronchopneumonia on 18Dec2020 and sepsis on an unspecified date. The events caused hospitalization and were reported as fatal. The clinical course was reported as follows: The patient was brought to the hospital by ambulance with severe sepsis and bronchopneumonia. She was resuscitated but unfortunately died shortly after arriving. The family reported that the patient received the coronavirus vaccine on 15Dec2020. It was reported that it is unclear from the family history whether she was unwell before she received the vaccine. The clinical outcome of acute bronchopneumonia and sepsis was fatal. The patient died on 19Dec2020. The cause of death was reported as acute bronchopneumonia and sepsis. It was not reported if an autopsy was performed. No follow-up attempts are possible; information on batch number cannot be obtained.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular the following relevant information is not available: medical history, autopsy report.; Reported Cause(s) of Death: Sepsis; Acute bronchopneumonia

No current illness for this event.

; ; ; ;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Lower respiratory tract infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority GB-MHRA-EYC 00236087, Safety Report Unique Identifier: GB-MHRA-ADR 24546153 . A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 18Dec2020 at single dose for covid-19 immunization. Medical history included vascular dementia from an unknown date and unknown if ongoing, severely frail from an unknown date and unknown if ongoing. This patient was severely frail as a result of vascular dementia and was a permanent nursing home resident. Concomitant medication included amoxicillin, doxycycline, sodium valproate, quetiapine, omeprazole, paracetamol. The patient experienced lower respiratory tract infection (LRTI) on an unspecified date. Patient died on 22Dec2020 within 5 days of receiving Covid vaccine, had been on antibiotics for LRTI for 2 days and had appeared to be improving, temperature was settled before vaccine was administered. She had a negative Covid swab at the onset of her symptoms. It would seem more likely that this patient died as a result of an evolving LRTI than as a result of receiving Covid vaccination. She was changed to amoxicillin 2 days before she died. The other outcome for Death was: Died 22Dec2020 but cause of death felt to be due to LRTI not vaccine. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender's Comments: The underlying predisposing condition (severely frail, lower respiratory tract infection) have been assessed to have played a major role toward the event.; Reported Cause(s) of Death: Lower respiratory tract infection

No current illness for this event.

; ; SODIUM VALPROATE; ; ;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Death; This is a spontaneous report from a contactable consumer and a physician downloaded from the Regulatory Authority number GB-MHRA-WEBCOVID-20201222043330 and Safety Report Unique Identifier GB-MHRA-ADR 24545938. A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT: EJ0553) via an unspecified route of administration on 20Dec2020 around 15:45 at single dose in left upper arm for COVID-19 vaccination. The patient ongoing medical history included Depression, Hypertension, chronic obstructive pulmonary disease and ischaemic heart disease. Patient is not enrolled in clinical trial. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient has not had symptoms associated with COVID-19. Concomitant medication included citalopram taken for Depression. The patient was taking unspecified concomitant medications for hypertension, chronic obstructive pulmonary disease (COPD) and ischaemic heart disease. The patient experienced death in Dec2020 (reported as in the evening of the 20Dec2020 or morning of 21Dec2020). Specifically, it was reported that the patient had the first dose of the vaccine at around 15:45 on 20Dec2020 and was observed for 15 minutes after with no side effects, the patient then left the site with family member. He was well that evening, he lived alone but spoke on the phone in the evening and felt well. On the 21Dec2020, after went to check on him and he was found in his bed passed away. When seeing the body, it was assumed that he had passed away in the evening of the 20Dec2020 or morning of 21Dec2020. Although unlikely, it was less than 24 hours after taking the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient was found dead in his flat the next day on 21Dec2020 by next of kin. He was dropped of home by family after the vaccination, he spoke to his family on the night after having the vaccination and told them he was feeling fine and was going to bed. He did not respond to telephone calls the next day (on Monday 21Dec2020) so the family went over to his flat and found he had passed away. The patient was registered at another surgery. Screening questions were asked, no contra indication found. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death

Chronic obstructive pulmonary disease; Depression; Hypertension; Ischaemic heart disease

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Myocardial infarct; Circulatory collapse; This is a spontaneous report from a contactable physician from the regulatory authroity. The regulatory authority report number is GB-MHRA-ADR 24553112 and GB-MHRA-WEBCOVID-20210104143047. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1688), via an unspecified route of administration, on 31Dec2020 at a single dose for COVID-19 vaccination. Medical history included mitral valve incompetence from 08May2020, myocardial ischaemia from 07May2020, acute myocardial infarction from 07May2020, cataract from 29Nov2019, chronic kidney disease from 03Oct2013, colitis ischaemic from 23May2013, basal cell carcinoma from 20Apr2012, transurethral bladder resection on 06Sep2005, neoplasm malignant (other/unspecified site) from 16Aug2005, debridement (arthroscopic debridement of patella) on 12Jan2005, and essential hypertension from 2005. The patient had not had symptoms associated with COVID-19. The patient was not been tested/or had an inconclusive test for COVID-19. The patient was not enrolled in clinical trial. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), betamethasone valerate (BETNOVATE), bisoprolol (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), glyceryl trinitrate (MANUFACTURER UNKNOWN), loperamide (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), phenoxymethylpenicillin (MANUFACTURER UNKNOWN), and ramipril (MANUFACTURER UNKNOWN). The patient experienced myocardial infarct and circulatory collapse on 31Dec2020. The event, myocardial infarct, was reported as fatal. It was reported that the patient collapsed at home the evening after vaccination. The clinical outcome of myocardial infarct was fatal and of circulatory collapse was not recovered. The patient died on 31Dec2020. The cause of death was reported as myocardial infarct. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarct

No current illness for this event.

; ; BETNOVATE; ; ; ; ; ; ;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Death; Malaise; Vomiting; This is a spontaneous report received from a contactable physician from the Regulatory Agency (RA). The Regulatory Authority report number is GB-MHRA-WEBCOVID-20210105172532, Safety Report Unique Identifier GB-MHRA-ADR 24558660. An 81-year-old female patient received bnt162b2 (BNT162B2) (lot# EJ1688), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included vascular dementia (advanced dementia), dementia Alzheimer's type (vascular and Alzheimer's mixed dementia), oral intake reduced (patient known to not be eating or drinking), fluid intake reduced, (patient known to not be eating or drinking), general physical health deterioration (patient known to be declining); all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death on 03Jan2021, malaise on 01Jan2021 with fatal outcome, vomiting on 01Jan2021 with fatal outcome. It was reported that 48 hours after vaccination the patient became unwell, vomited and then died on 03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 27Dec2020. Patient has been not tested positive for COVID-19 since having the vaccine. It was not reported if an autopsy was performed. It was not known whether vaccine caused reaction. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Malaise; Vomiting; Death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

breathless on exertion; This is a spontaneous report received from a contactable other health professional received from the United Kingdom's Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-ADR 24561910, other case identifier number: GB-MHRA-WEBCOVID-20210106094618. An 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot no: EJ1688), via an unspecified route of administration on 30Dec2020 single dose for covid-19 immunisation. Medical history included Bowen's disease, basal cell carcinoma, chronic kidney disease and essential hypertension, all unknown if ongoing. Concomitant medication included alfacalcidol (unknown manufacturer), amlodipine (unknown manufacturer), atorvastatin (unknown manufacturer), clopidogrel (unknown manufacturer), prazosin (unknown manufacturer), sodium bicarbonate (unknown manufacturer), folic acid (unknown manufacturer), furosemide (unknown manufacturer). The patient experienced breathless on exertion on 02Jan2021. The patient died on 02Jan2021 due to the event. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on unknown date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dyspnoea exertional

No current illness for this event.

; ; ; ; ; ; ;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Sudden death; This is a spontaneous report from a contactable physician from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24556755. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0553), via an unspecified route of administration on 19Dec2020 as single dose for COVID-19 immunization. Medical history included Waldenstrom's macroglobulinemia for Waldenstrom's macroglobulinaemia, memory impairment, with recent memory problems, cerebrovascular accident , with previous CVA, joint swelling , reported as slight ankle swelling awaiting head CT scan and bloods, oesophagitis, and cholesterol, all from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (MANUFACTURER UNKNOWN) for Waldenstrom's macroglobulinaemia, lansoprazol (MANUFACTURER UNKNOWN) for oesophagitis, simvastatin (MANUFACTURER UNKNOWN) for blood cholesterol. The patient had sudden death on 29Dec2020. The patient died on 29Dec2020. It was not reported if an autopsy was performed. The reporter did not think the COVID vaccination caused the patients death; It did not appear to be related. The patient was seen by the physician on the 24th (not otherwise specified), and was fine. The patients son also saw the patient on the 28th (not otherwise specified) and also fine with no side effects from the jab. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently provided, the company considers the patient death is unrelated to the vaccine use; the advance old patient having multiple pre-existing medical conditions including Waldenstrom's macroglobulinaemia and cerebrovascular accident, which more likely led the patient to sudden death.; Reported Cause(s) of Death: Sudden death unexplained

No current illness for this event.

; LANSOPRAZOL;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Cardiac arrest; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-20210105171610, Safety Report Unique Identifier GB-MHRA-ADR 24558665. A male patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Dec2020, at single dose for covid-19 vaccination. Medical history included ongoing dementia, and cardiac pacemaker insertion on an unknown date. Patient has not had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. The patient's concomitant medications were not reported. The patient experienced cardiac arrest on 31Dec2020. Had spontaneous cardiac arrest 9 days (to be clarified) after vaccination doubtful implicated but new vaccine of course. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The patient died of cardiac arrest on 31Dec2020. It was not reported if an autopsy was performed. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest

Dementia

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

hemolytic anemia; reduced air entrance; passed away; low blood pressure; jaundice appeared on the whole body with lymphocytosis; jaundice appeared on the whole body with lymphocytosis; shortness of breath in mild efforts; weakness which expressed by shortness of breath in mild efforts; hands tremor; shortness of breath; This is a spontaneous report from a contactable consumer received via regulatory authority. This consumer reported different fatal events for four patients. This is the third of four reports. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was not specified) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunisation. Medical history included Kerattis, prostatectomy other, blood pressure problems (treated with nifedipine and hydrochlorothiazide/ramipril (TRITACE COMP)), hyperlipidemia (treated with statins), oncological patient-underwent radical restriction of the prostate, and sensitivity to phenylephrin. Concomitant medications were not reported. Three days after the vaccine (on 24Dec2020) he started to feel shortness of breath, arrived for hospitalization 10 days after vaccination. Five days after vaccination (on 26Dec2020) he experienced weakness which expressed by shortness of breath in mild efforts, hands tremor. 6 days after vaccination (on 27Dec2020) jaundice appeared on the whole body with lymphocytosis. On the day after, he referred to the physician and blood tests were sent. He was hospitalized following diagnosis of hemolytic anemia. He received two blood doses and steroids. Two hours before he passed away, low blood pressure was measured and reduced air entrance, CPR was performed without success and the patient passed away. The date of death was unknown. The cause of death was unknown. It was unknow if an autopsy was performed. The outcome of event unknown cause of death was fatal, and of other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : IL-PFIZER INC-2021019507 Same reporter, same product, different patient/events; Reported Cause(s) of Death: passed away

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Died in sleep; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number was GB-MHRA-ADR 24556999 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-20210105122200. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1688), via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 vaccination. Medical history included craniotomy in 2019, acute subdural haematoma in 2019, and ongoing bedridden following a craniotomy for an acute subdural haematoma from 2019. The patient was not enrolled in clinical trial. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), ferrous sulfate (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), flucloxacillin (MANUFACTURER UNKNOWN), colecalciferol (FULTIUM D3), gabapentin (MANUFACTURER UNKNOWN), hypromellose (MANUFACTURER UNKNOWN), levothyroxine sodium (MANUFACTURER UNKNOWN), betamethasone dipropionate/clotrimazole (LOTRIDERM) , macrogol (MANUFACTURER UNKNOWN), tramadol hydrochloride (MAROL), omeprazole (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN), senna spp. (MANUFACTURER UNKNOWN), and influenza vaccine inact sag 4v (FLUCELVAX TETRA). On 05Jan2021, the patient died in his sleep. The clinical course was as follows: The patient had not had symptoms associated with COVID-19. The patient received the vaccination on 31Dec2020. The patient had tested negative for COVID-19 since having the vaccine on an unknown date. There were no other reactions noted but the patient died in his sleep overnight on 05Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Died in sleep

Bedridden (Patient bed bound following a craniotomy for an acute subdural haematoma in 2019)

; ; ; ; ; FULTIUM D3; ; ; ; LOTRIDERM; ; MAROL; ; ; ; SENNA [SENNA SPP.]; FLUCELVAX TETRA

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

tested Covid positive/suspected COVID-19; tested Covid positive/suspected COVID-19; Shortness of breath; Fall; This is a spontaneous report from a contactable physician from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106123053. An 81-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection, shortness of breath on 03Jan2021. Reaction to vaccine is none. Patient was admitted with fall and on the floor for 5 hours on 03Jan2021. He was tested COVID positive on admission on 03Jan2021. So he tested positive about two weeks after first dose of Pfizer COVID-19 vaccine. Patient was suspected COVID-19 from 03Jan2021. The patient underwent lab test included COVID-19 virus test: Yes - Positive COVID-19 test (03Jan2021). Outcome of the events was fatal. The patient died on 03Jan2021. It was unknown if an autopsy was performed. Cause of death reported as SARS-CoV-2 infection/suspected COVID-19, shortness of breath and fall. No follow-up attempts possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection/suspected COVID-19; SARS-CoV-2 infection/suspected COVID-19; shortness of breath; Fall

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Death (death certificate: uncertain type of death); evening vomiting; This is a spontaneous report from a non-contactable physician the Regulatory Authority. This is a report received from the Regulatory Authority. Regulatory authority report number was DE-PEI-CADRPEI-2021011672. A 79-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EJ6796), intramuscular on 30Dec2020 as a single dose for COVID-19 immunization. Medical history included especially autoimmune encephalopathy of paraneoplastic origin and suspected urothelial carcinoma of the bladder. The patient's concomitant medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) on 03Dec2020 for immunization and was tolerated. On 31Dec2020 (also reported as 30Dec2020), the patient developed evening vomiting which was dark in color and most likely food related. On 31Dec2020 at 04:35, the patient died. It was not reported if an autopsy was performed. The clinical outcome of vomiting was reported as fatal; however, the cause of death was reported as unknown cause of death. The vomiting and unknown cause of death were reported as medially significant and fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 5th of 8 patients. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

passed unexpectedly; This is a spontaneous report from a contactable nurse communicated to a Pfizer colleague. This nurse reported similar death events for 8 patients. This report is for 8th of 8 patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient passed unexpectedly on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: passed unexpectedly

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Hypotension/ hypotensive; Hypoxia/ hypoxic; Tachypnoea/ tachypnoeic; Unresponsive to stimuli/ unresponsive; Death; Somnolence/ Drowsy; Hypoglycaemia/ hypoglycaemic; Hypothermia/ hypothermic; Hypophagia/ reduced oral intake; Fall; Confusional state/ confused; Headache; Chills; Skin ulcer/ Leg ulcers; Oedema peripheral/ bilateral leg oedema; Oxygen saturation decreased/ low saturations; feel unwell; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency, manufacturer report number GB-MHRA-ADR 24566650. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, moderate aortic stenosis from an unknown date and unknown if ongoing, pulmonary hypertension from an unknown date and unknown if ongoing, possible papillary fibroelastoma from Jun2019 and unknown if ongoing, non-specifically lethargic from Dec2020 and unknown if ongoing. The patient had been non-specifically lethargic for 1-2 weeks in early Dec2020. The patient's concomitant medications were not reported. In the 24-48 hours following vaccine, developed headache and chills. Daughter thought it was all post-vaccination inflammatory response and that it would settle. Continued to feel unwell, reduced oral intake, 2x falls and became confused on 25Dec2020. The patient was admitted on 26Dec2020, hypothermic. Consultant review 27Dec2020 and no diagnosis documented. Leg ulcers and bilateral leg oedema noted, supplemental oxygen commenced due to low saturations in Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to 29Dec2020, given intravenous treatment and blood sugars improved. National Early Warning Score (NEWS) of 14 (hypotensive, hypoxic, tachypnoeic, unresponsive) on 29Dec2020 and Medical Emergency Team (MET) call put out at 06:50. By the time MET team arrived the patient had died. The patient experienced headache on Dec2020 , chills on Dec2020, hypophagia on 25Dec2020, fall on 25Dec2020, confusional state on 25Dec2020 , hypothermia on 26Dec2020, skin ulcer on Dec2020, oedema peripheral on Dec2020, oxygen saturation decreased on Dec2020, somnolence on 28Dec2020, hypoglycaemia on 28Dec2020, hypotension on 29Dec2020, hypoxia on 29Dec2020, tachypnoea on 29Dec2020, unresponsive to stimuli on 29Dec2020, death on 29Dec2020 , feel unwell on 25Dec2020. All the events except feel unwell were reported as serious as hospitalization and death. The patient underwent lab tests and procedures which included computerised tomogram head: no bleed, C-reactive protein: 37, echocardiogram: possible papillary fibroelastoma- not investigated in Jun2019, white blood cell count: normal. The patient died on 29Dec2020. An autopsy was not performed. The outcome of the event feel unwell was unknown, while other remain events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Headache; Chills; Fall; Hypophagia/ reduced oral intake; Confusional state/ confused; Skin ulcer/ Leg ulcers; Oedema peripheral/ bilateral leg oedema; Oxygen saturation decreased/ low saturations; Somnolence/ Drowsy; Death; Hypoglycaemia/ hypoglycaem

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 1st of 8 patient. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034597 same drug, reporter and event but different patient;US-PFIZER INC-2021034598 same drug, reporter and event but different patient;US-PFIZER INC-2021034599 same drug, reporter and event but different patient;US-PFIZER INC-2021034600 same drug, reporter and event but different patient;US-PFIZER INC-2021034601 same drug, reporter and event but different patient;US-PFIZER INC-2021034603 same drug, reporter and event but different patient;US-PFIZER INC-2021034596 same drug, reporter and event but different patient.; Reported Cause(s) of Death: expired before receiving the second dose

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 2nd of 8 patients. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: expired before receiving the second dose

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 3rd of 8 patients. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported death and the administration of COVID 19 vaccine, bnt162b2. However, more information on the patient's underlying medical condition, concomitant medications, patient's age group, clinical course and relevant lab tests would be helpful for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: expired before receiving the second dose

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 4th of 8 patient. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number has been requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 7th of 8 patient. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Death; This is a spontaneous report from four non-contactable consumers via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Dec2020 at a single dose for COVID-19 immunization. Ongoing medical history included Alzheimer's Disease, encephalopathy, hypertension, acute kidney failure, urinary retention and recent urinary tract infection (UTI), all from an unspecified date. Concomitant medication included acetaminophen (MANUFACTURER UNKNOWN), bisacodyl (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), loperamide (MANUFACTURER UNKNOWN), ondansetron (MANUFACTURER UNKNOWN), senna alexandrina (SENNA PLUS), vitamin d3 (MANUFACTURER UNKNOWN). The patient had no known drug allergies. The patient experienced death on 30Dec2020. The vaccine was given on 28Dec2020 with no adverse events and no issues on 29Dec2020. The patient died on 30Dec2020, at approximately 2:00 AM. It was unknown if an autopsy was performed. It was unknown if the event was related to the suspect drug, the administrator marked as natural causes. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death

Acute kidney failure; Alzheimer's disease; Encephalopathy; Hypertension; Urinary retention; UTI

ACETAMINOPHEN; ; ; ; HYDROCODONE/ACETAMINOPHEN; ; ; SENNA PLUS [SENNA ALEXANDRINA]; VITAMIN D3

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

resident coded and expired; This is a spontaneous report from a non-contactable consumer via Pfizer Sponsored Program. A 63-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EH9899) intramuscular at single dose at left arm on 28Dec2020 for Covid-19 immunisation. Medical history included no current Illness, no known allergies, but preexisting conditions: dysphagia, violent behaviors, depressive disorder, schizophrenia, aspiration, gastrooesophageal reflux disease (GERD), hyperlipidaemia, bipolar disorder, rectal bleeding, hypertension. The patient had no birth defect. Concomitant medication included asa (ASA) at 81mg, lisinopril (LISINOPRIL) at 10mg daily, ferrous sulfate (FERROUS SULFATE) at 325 (unit unknown), olanzapine (ZYPREXA) at 20mg, morniflumate (FLOMAX [MORNIFLUMATE]) at 0.4 (unit unknown), famotidine (FAMOTIDINE) at 20mg, ascorbic acid (VIT C), carbamazepine (CARBAMAZEPINE) at 250mg bid, valproate semisodium (DEPAKOTE) at 750mg bid, metformin (METFORMIN) at 1000 (unit unknown) bid, sertraline (SERTRALINE) at 100 (unit unknown) bid, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), buspirone hydrochloride (BUSPAR) at 10mg tid, polycarbophil calcium (FIBERCON). The patient died on 29Dec2020. The patient had no ER or Doctor visit and was not hospitalized. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: resident coded and expired

No current illness for this event.

ASA; ; ; ZYPREXA; FLOMAX [MORNIFLUMATE]; ; VIT C; ; DEPAKOTE; ; ; ALBUTEROL [SALBUTAMOL]; BUSPAR; FIBERCON

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

patient passed away with in 90 minutes of getting vaccine; This is a spontaneous report from three non-contactable consumer reporting on behalf of the patient via a Pfizer sponsored program, Corporate (Pfizer) Social Media Platforms. A 90 (unspecified unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL0142, unknown expiration), via an unspecified route of administration in right arm (reported as AR) on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was a nursing home patient and received the first dose of COVID vaccine on 30Dec2020. The patient was monitored for 15 minutes after getting shot. Staff reported that the patient was 15 days post COVID. The patient passed away with in 90 minutes of getting vaccine on 30Dec2020. The patient did not require office/ ER visit. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Patient passed away with in 90 minutes of getting vaccine

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

Reported causes of death: Diarrhoea; This is a spontaneous report from a contactable healthcare professional via agency and a non-contactable consumer via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. An elderly patient of an unspecified age (also reported as were in their early to mid-60's) and gender received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 10Dec2020 at a single dose for COVID-19 immunisation. Medical history included pseudomembranous colitis (broad), gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), and noninfectious diarrhoea (narrow) . The patient's concomitant medications were not reported. The patient experienced diarrhoea on an unspecified date in 2020. It was reported that most of the deaths after the COVID-19 vaccine occurred within 24-48 hours after the shot. The write-ups that accompanied the reports furnished details about these sad fatalities, including the astonishing fact that some of the decreased had actually experienced and recovered from COVID-19 (raising questions about why they were vaccinated). It was also reported that the event was not life-threatening, did not result to a birth defect or permanent disability, did not require any office/ER/doctor visit, and did not require any hospitalization. The patient died on 10Dec2020. It was not reported if an autopsy was performed. The reported cause of death: diarrhoea. No follow up attempts are possible, information about the lot/batch number cannot be obtained.; Sender's Comments: Based on the available information the event diarrhea resulting in death is attributed to patients preexisting medical conditions including pseudomembranous colitis, gastrointestinal nonspecific symptoms and therapeutic procedures, and noninfectious diarrhea. However, based on a close chronological association (same day) contributory role of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine) to event exacerbation cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Reported causes of death: Diarrhoea

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Dec., 2020

reported causes of death :circulatory collapse; asystole; reported causes of death :circulatory collapse; asystole; This is a spontaneous report from a Pfizer-sponsored program received from the Regulatory Authority-WEB GB-MHRA-WEBCOVID-20201214111558, satety Report unique Identifier GB-MHRA-ADR 24542972 and EU-EC-10007191566 received via Regulatory Authority 908245. A contactable pharmacist and three consumers reported that an adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included acetylsalicylic acid, amiloride HCl, allopurinol, desogestrel, furosemide, levothyroxine, sildenafil, and spironolactone. The patient experienced circulatory collapse and asystole on 13Dec2020. The patient died due to asystole and circulatory collapse on 13Dec2020. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information Is expected.; Sender's Comments: The information available is limited and does not allow a meaningful case evaluation. However, based solely on a close chronological association (same day) a causal relationship between events circulatory collapse and cardiac arrest and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: reported causes of death :circulatory collapse; asystole; reported causes of death :circulatory collapse; asystole

No current illness for this event.

; AMILORIDE HCL; ; ; ; ; ;

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

Cardiac event, 2 days after vaccination, patient expired.

none

Enteric Coded Aspirin, Atenolol, Centrum Silver, Citrical, Levothyroxin, Lisinipril, Phillips Colon Health Caps, Vitamin D

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

COVID-19; COVID-19; Pneumonia; respiratory failure; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Jan2021 for COVID-19 immunization. Medical history included Alzheimer's and others. No known allergies. Concomitant medications included unspecified medications. The reporter's mother in law was tested for COVID-19 at a nursing facility on 25Dec2020 and she was negative. On 02Jan2021, she received the first dose of Pfizer vaccine. On 04Jan2020, she developed a high fever, needed oxygen and was positive for COVID-19. Date of death was 04Jan2021. The cause of her death was listed as pneumonia, respiratory failure and COVID-19. No autopsy performed. No treatment received. No one knew if the vaccination contributed to her death. It was hard to know if her death was due to the administration of the vaccine or it exacerbated the COVID19 symptoms which led to her death. Since this was unknown, it could have been a possibility. The reporter wanted to give us this information because we might want to consider having high risk population, patients with underlying conditions, older population tested for COVID-19 prior to the vaccination, as this is not currently a recommendation or a requirement. All is very new and they are all learning so the reporter wanted to share this information with us. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was fatal. Information about Lot/Batch has been requested.; Sender's Comments: The association between the fatal event lack of effect (pneumonia, respiratory failure and COVID-19) with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

Acute cardio-respiratory event and died a few hours later; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210107093111. Safety Report Unique Identifier GB-MHRA-ADR 24565959. An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose, on 04Jan2021, for COVID-19 immunisation. Patient was elderly and frail and gradually declining in mobility, communication and memory over the last 12 months. Relevant medical history also included vascular dementia form an unspecified date and unknown if ongoing. Concomitant medications were unknown. Patient was not enrolled in clinical trial. COVID-19 virus test was performed twice on an unspecified date, in Dec2020 and on 18Dec2020 and the results were negative. On 04Jan2021, at 06:00 PM, the patient experienced acute cardio-respiratory event and died a few hours later. It was unknown if autopsy was done. Since the vaccination, the patient has not been tested for COVID-19. Patient did not have symptoms associated with COVID-19. The patient was kept comfortable in the nursing home in these last few hours. There was no way to know whether the vaccine was to blame at all, it was unlikely. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory failure

Communication disorder NOS; Frailty; Memory impairment; Mobility decreased

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

Death; Vomiting; This is a spontaneous report from a contactable other health professional from the Regulatory Agency. The regulatory authority report number is GB-MHRA-ADR 24573192. An elderly female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: BJ1688 and EJ1688; as reported), via an unspecified route of administration on 05Jan2021 at 12:26 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had not had symptoms associated with COVID-19; and was not enrolled in the clinical trial. On 05Jan2021 at 12:51, the patient experienced vomiting (non-serious); 25 minutes post vaccine (had further vomiting episodes). On 07Jan2021 at 01:00, the patient experienced death; which caused death, and was medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative COVID-19 test on an unspecified date. The clinical outcome of the event, vomiting, was unknown. The clinical outcome of the event, death, was fatal. The patient died on 07Jan2021 at 01:00 due to unknown cause of death. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

This is a spontaneous report from a contactable consumer. This consumer reported different fatal events for four patients. This is the second of four reports. An 82-year-old female patient in a nursing home received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4238) via an unspecified route of administration on 04-Jan-2021 at a single dose for COVID-19 immunisation. Medical history included background of asthma, dementia, depression, gastrointestinal and heart failure. Concomitant medications were not reported. 4 Hours after the receipt of the vaccine, she was found in her room on the floor with a bruise on her forehead apparently from a fall, CPR was performed by nursing home staff. Staff performed CPR, asystole without heart sounds, CPR continued for 23 minutes without any change and death was declared. The events occurred in Jan 2021. The date of death was in Jan 2021. The outcome of events was fatal. It was unknown if an autopsy was performed. Sender's Comments: Linked Report(s): IL-PFIZER INC-2021019507 Same reporter, same product, different patient/events; Reported Cause(s) of Death: was found in her room on the floor with a bruise on her forehead apparently from a fall; was found in her room on the floor with a bruise on her forehead apparently from a fall.

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

"heart failure; Death; feeling sick; changes with speech and mobility; changes with speech and mobility; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210111094207, Safety Report Unique Identifier: GB-MHRA-ADR 24577774. A 97-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1688), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Jan2021, the patient experienced feeling sick (medically significant), changes with speech and mobility (speech disorder) (medically significant). On 11Jan2021, the patient experienced death (death, medically significant). On an unspecified date, the patient experienced heart failure (death, medically significant). The clinical course was reported as follows: ""The resident had got heart failure."" The patient was feeling sick on 10Jan2021 and was concerned as there were changes with speech and mobility. Emergency was called, and the ambulance arrived. It was stated the sats were low and blood pressure was low. The ambulance crew called for an out of hours general practitioner (GP) to come and see the patient. The out of hours general practitioner (GP) visited on 10Jan2021 and advised ""she maybe poorly due to having the Covid-19 vaccine"" that was administered on the 08Jan2021. The resident passed away at 07:20 on morning 11Jan2021. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative COVID-19 test on an unspecified date, oxygen saturation (sats): low on 10Jan2021, blood pressure: low on 10Jan2021. The clinical outcome of the event, death and heart failure, was fatal. The clinical outcome of the event, feeling sick and changes with speech and mobility, was unknown. The patient died on 11Jan2021 due to heart failure. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: heart failure"

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

patient died while there were no other complaints at that time; This is a spontaneous report received from a contactable consumer (Pfizer colleague). A 99-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died 3 days after the vaccination while there were no other complaints at that time on 10Jan2021. The patient died on 10Jan2021. It was not reported if an autopsy was performed. The family assessed there was a causal relationship with the vaccine. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died 3 days after the vaccination while there were no other complaints

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

Resident expired

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authorityy -WEB NO-NOMAADVRE-FHI-2021-Urpw8, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013915. An 82-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 05Jan2021 11:30 at single dose for Covid-19 immunisation. Medical history included cognitive deterioration (advanced/severe cognitive impairment), general physical condition decreased, reduced general condition and living in nursing home, all ongoing. The patient's concomitant medications included buprenorphine (NORSPAN) from 07Dec2020 for pain, sodium picosulfate (LAXOBERAL) from 10Dec2020 for constipation, bisacodyl (DULCOLAX) from 26Nov2020 for constipation. Patient had gradually declining functional level and general condition/AT over several months. Vaccinated with bnt162b2 on 05Jan2021 and died on 11Jan2021. It was not reported if an autopsy was performed. The Regulatory Authority assessed the causality between bnt162b2 and the event death as Possible. Comment: Based on the information in the report it is likely that the underlying diseases is the cause of the death. However, there is a temporal correlation and it cannot be entirely ruled out that the vaccine could have contributed to the worsening of the patient's underlying diseases. It can also be that the event had a completely different cause which coincidentally developed after the vaccination. Based on the criteria from WHO we assess the causal relationship between Comirnaty and death as Possible. Meaning, a reaction, including pathological lab samples, that happens in a temporal correlation to the use of a pharmaceutical but which could also be caused by underlying disease, other pharmaceuticals or chemicals. Based on the given criteria the report is assessed as serious. Reported Cause(s) of Death: Death.

Cognitive deterioration (advanced/severe cognitive impairment.); General physical condition decreased; Living in nursing home; Reduced general condition

NORSPAN [BUPRENORPHINE]; LAXOBERAL; DULCOLAX [BISACODYL]

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Jan., 2021

her mother passed away 7-8 days after receiving the vaccine; This is a spontaneous report from a contactable consumer, the daughter of the patient. A female patient of an unspecified age received the first dose of COVID-19 mRNA VACCINE (MANUFACTURER UNKNOWN), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Jan2021 about 7-8 days after receiving the vaccine, the patient passed away. The patient was fine before she received the vaccine and then passed away 7-8 days later. The cause of death was not reported. It was not reported if an autopsy was performed. The reporter thought her mother's death had everything to do with the COVID-19 vaccine. The lot number for the vaccine was not provided and will be requested during follow up.; Reported Cause(s) of Death: Death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

Diarrhoea; This is a spontaneous report from a contactable other healthcare professional via Agency and downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-20201212222117, Safety Report Unique Identifier GB-MHRA-ADR 24542707 and EU-EC-10007191252. An elderly patient of an unspecified gender received bnt162b2 (batch/lot number not provided), via an unspecified route of administration in 2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhoea in 2020. The patient died due to diarrhoea on 10Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information on the lot/batch number not obtainable. No further information is expected.; Reported Cause(s) of Death: diarrhoea

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

Death in connection with the vaccination and/or Covid19 disease / positivity; Death in connection with the vaccination and/or Covid19 disease / positivity; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported 2 deceased were autopsied, death in connection with the vaccination or Covid19 disease / positivity.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021006738 same reporter, same product, same event, different patient; Reported Cause(s) of Death: Death in connection with the vaccination and/or Covid19 disease / positivity; Death in connection with the vaccination and/or Covid19 disease / positivity

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

Fever; This is a spontaneous report from a newsletter, from a contactable consumer (profession unspecified). Regulatory authority report number was not provided. An elderly female patient received bnt162b2 (COMIRNATY, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included ongoing dementia in a palliative state. The patient's concomitant medications were not reported. The verbatim narrative was reported as follows: 'Status report on suspected side effects from vaccination against covid-19. The report on the second death was received on 05Jan2020. It concerns an elderly female with dementia in a palliative state. The female was vaccinated with Comirnaty, had fever on an unspecified date and passed away three days later. The information in the report is very brief and will seek additional information from the reporter. Currently, has no information on the female's confirmed cause of death and there is no established causality with the vaccine.' The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Reported Cause(s) of Death: had fever and passed away three days later

Dementia

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

heart attack; This is a spontaneous report from a non-contactable consumer (discovered on news page and heard in news). An elderly female patient (elderly than 90-year old from home for elderly) received bnt162b2 (COMIRNATY) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization (other details not reported). Medical history included heart attack. Concomitant medications were not reported. patient experienced heart attack six hours after vaccination that obviously occurred after repeated heart attack. It was stated that heart attack was not connected to the vaccination. There was no acute allergic reaction. Case was further investigated (independent committee) and confirmed the vaccination was not reason of death. Patient died from heart attack, it was unknown if autopsy was done. Information on batch number has been request.; Sender's Comments: Fatal heart attack is not related to bnt162b2 use; the advanced old patient had pre-existing medical condition including previous episode of heart attack thus the underlying cardiovascular provided an explanation for the event onset.; Reported Cause(s) of Death: heart attack

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

Death in connection with the vaccination and/or COVID-19 disease/positivity; Death in connection with the vaccination and/or COVID-19 disease/positivity; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, there was death in connection with the vaccination and/or COVID-19 disease/positivity. It was reported that: two deceased were autopsied, whose death was in connection with the vaccination or COVID-19 disease/positivity. The clinical outcome of death in connection with the vaccination and/or COVID-19 disease/positivity was fatal. The patient died on an unspecified date. The cause of death was reported as: death in connection with the vaccination and/or COVID-19 disease/positivity. An autopsy was performed, and the results were not reported.; Sender's Comments: The association between the event lack of effect (death was in connection with the vaccination or COVID-19 disease positivity) with BNT162b2 can not be fully excluded given the limited information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021006905 same reporter, same product, same event, different patient; Reported Cause(s) of Death: Death in connection with the vaccination and/or COVID-19 disease/positivity; Death in connection with the vaccination and/or COVID-19 disease/positivity

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

death following BNT 162b2 vaccination; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (COMIRNATY; PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as the first single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Death following BNT162B2 vaccination was noted on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

died; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported the patient was a doctor, died after the vaccine with no apparent disease. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

thrombopenia; pulmonary embolism; neutropenia fever; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for a patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced thrombopenia, pulmonary embolism and neutropenia fever on an unspecified date. The clinical outcome of thrombopenia, pulmonary embolism and neutropenia fever was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: thrombopenia; pulmonary embolism; neutropenia fever

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician received by Regulatory Agency . The regulatory authority report number is GB-MHRA-ADR 24558365 & GB-MHRA-WEBCOVID-20210105143744. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient experienced SARS-coV-2 infection on 27Dec2020. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on an unspecified date. The clinical outcome of SARS-coV-2 infection was fatal. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

7 residents expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 6th of 8 patients. A patient of unspecified age and gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The event death is assessed as related to BNT162b2 vaccine and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: 7 residents expired before receiving the second dose

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

died; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that an 83-year-old female patient (reporter mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included hospice care and dementia. The patient's concomitant medications were not reported. The patient died one day after getting vaccine. She was reportedly in good health the day before receiving vaccine. She was on hospice, frail, but in good condition and checked by a hospice nurse the day before which she reported her in good health considering. She was with dementia but stable in her health. The reporter read investigating 23 deaths of people receiving vaccine in similar conditions. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: died

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

Three weeks after taking the Pfizer vaccine (COVID Vaccine) he developed ITP. He was bleeding from his head, his brain; Three weeks after taking the Pfizer vaccine (COVID Vaccine) he developed ITP. He was bleeding from his head, his brain; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Three weeks after taking the pfizer vaccine (covid vaccine) he developed ITP (Idiopathic thrombocytopenic purpura), he was bleeding from his head, his brain on an unspecified date in Dec2020 and he died. The patient was healthy, he never had ITP in the past. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be completely excluded for events idiopathic thrombocytopenic purpura and hemorrhage brain. However information is limited and does not allow a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Three weeks after taking the Pfizer vaccine (COVID Vaccine) he developed ITP. He was bleeding from his head, his brain; Three weeks after taking the Pfizer vaccine (COVID Vaccine) he developed ITP. He was bleeding from his head, his brain

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

received the vaccine on Tuesday and was found dead at his kitchen table Wednesday afternoon; This is a spontaneous report from a contactable consumer. An 89 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the vaccine on Tuesday (unspecified date) and was found dead at his kitchen table on Wednesday afternoon (unspecified date). Cause of death was unknown. It was unknown if an autopsy was performed. Information about batch/lot number has been requested.; Reported Cause(s) of Death: received the vaccine on Tuesday and was found dead at his kitchen table Wednesday afternoon

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

"died; acute immune thrombocytopenia; This is a spontaneous report from two contactable consumers. A patient of unspecified age and gender received BNT162B2(lot number and expiration date not provided) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died after receiving the covid vaccine on an unknown date. The patient developed acute immune thrombocytopenia on an unknown date. It was unknown if autopsy was performed. The cause of death was unknown. The outcome of the event ""died"" was fatal and of the event "" acute immune thrombocytopenia"" was unknown. The reporter wondered if a platelets blood problem may lead to death and if who have a blood platelets condition like essential thrombocytosis should not risk taking the vaccine. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Died"

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

died several hours after receiving a Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died several hours after receiving a Covid-19 vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The person had tested positive for the virus (Covid-19) in late Dec2020. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: died several hours after receiving a Covid-19 vaccine

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)

DEATH

Unknown

Unknown Date

Autoimmune disease; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A male patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced autoimmune disease on an unspecified date. The patient died on an unspecified date due to autoimmune disease. It was unknown if an autopsy was performed. The information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the fatal autoimmune disease and suspect vaccine BNT162B2. Additional information regarding therapy duration, relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.; Reported Cause(s) of Death: Autoimmune disease

No current illness for this event.

No other medications for this event.

COVID19 (COVID19 (UNKNOWN)) (1202)

DEATH

65+ years

Jan., 2021

COVID 19 vaccine, unknown which company Chronically ill in a skilled nursing facility found diaphoretic, hypotensive, hypoxia to 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have been related to vaccine date of vaccination 1/6/20 hx covid 19 PNA in April 2020

CVA seizure disorder all chronic HTN CAD had COVID 19 in April 2020

Unavail

COVID19 (COVID19 (UNKNOWN)) (1202)

DEATH

65+ years

Jan., 2021

5 days after receiving his COVID vaccination the patient had a spontaneous (nontraumatic) subarachnoid hemorrhage which was fatal. The patient had previously been stable on his coumadin dosing with therapeutic INRs for the past several months per his wife. At time of presentation his blood pressure in the ER was elevated to 223/94 and his INR was risen to 3.1

none

pantoprazole 40 mg daily potassium chloride 10 meq daily sotalol 120mg BID warfarin 2.5mg daily warfarin 5mg weekly furosemide 40mg daily allopurinol 200 mg daily donepezil 10mg daily lisinopril 5mg daily

Note: Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse event (possible side effect).

Top OptionsNotesCitation Query Criteria

Notes:

Caveats:

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA's multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as "safety signals." If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.

Key considerations and limitations of VAERS data:

Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS, whether or not they believe the vaccine was the cause.
Reports may include incomplete, inaccurate, coincidental and unverified information.
The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines.
VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date for which data are available.
VAERS data do not represent all known safety information for a vaccine and should be interpreted in the context of other scientific information.

Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers, and Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100% in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many reports include more than 1 Symptom. When more then 1 Symptom occurs in a single report, then the percentage of Symptoms to unique events is more than 100%. More information.

Data contains VAERS reports processed as of 01/29/2021. The VAERS data in WONDER are updated monthly, yet the VAERS system receives continuous updates including revisions and new reports for preceding time periods. More information.

Values of Event Category field vary in their availability over time due to changes in the reporting form. The "Emergency Room/Office Visit" value was avaliable only for events reported using the VAERS-1 form, active 07/01/1990 to 06/29/2017. The "Congenital Anomaly/Birth Defect", "Emergency Room", and "Office Visit" values are available only for events reported using the VAERS 2.0 form, active 06/30/2017 to present. These changes must be considered when evaluating count of events for these categories.

Help:

See The Vaccine Adverse Event Reporting System (VAERS) Documentation for more information.

Query Date:

Feb 11, 2021 2:09:35 AM

Top Options NotesCitationQuery Criteria

Suggested Citation:
United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 - 01/29/2021, CDC WONDER On-line Database. Accessed at http://wonder.cdc.gov/vaers.html on Feb 11, 2021 2:09:35 AM

Top Options Notes CitationQuery Criteria

Query Criteria:
Title:	Covid19 Vaccines - Death
Event Category:	Death
Symptoms:	DEATH
Vaccine Products:	COVID19 VACCINE (COVID19)
VAERS ID:	All
Group By:	Vaccine; Symptoms; Age; Month Vaccinated; VAERS ID
Show Totals:	False
Show Zero Values:	Disabled

Content source: CDC WONDER