The Vaccine Adverse Event Reporting System (VAERS) Results

Covid19 Vaccines - Permanent disability

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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)

ABDOMINAL PAIN

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

ABDOMINAL PAIN UPPER

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

ACOUSTIC STIMULATION TESTS

65+ years

Jan., 2021

Sudden Sensorineural Hearing Loss in left ear. Symptoms began Friday evening Jan. 8, 2021. Sounded like muffled sound in my ear, water running, ringing. Then on Saturday Jan.9, 2021 my left ear felt like it had to pop and I felt my hearing was impaired. By Sunday evening Jan. 10, 2021, I could barely hear out of my left ear. I called MD immediately Monday morning, Jan. 11, 2021 and was seen that afternoon. I was examined and had a hearing test. I was diagnosed with SSHL and started treatment of a series of steroid injections directly into my eardrum to save my hearing immediately. I have had 2 injections and hearing test since then. The doctors feel this was a side effect of the COVID vaccine due to my compromised immune system, but not an allergic reaction, but a side effect. I had the same condition about 15 years ago from a virus.

None

Eplerenone, Metoprolol, Digestive Advantage Lactose Defense, D3,B12, Biotin, Potassium

ACOUSTIC STIMULATION TESTS ABNORMAL

30-39 years

Dec., 2020

Sudden hearing loss right ear accompanied by tinnitus

No current illness for this event.

Levothyroxine

Sudden hearing loss right arm accompanied by tinnitus

No current illness for this event.

Levothyroxin

ACUTE ABDOMEN

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

AGITATION

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

ALOPECIA

65+ years

Jan., 2021

Tufts of my hair came out by the handful - first time in my life I have experienced ANY hair loss! It is still ongoing and I am worried it will result in permanent baldness.

none

normal OTC vitamins, same vitamins for the last 20 years

ANGIOGRAM

65+ years

Dec., 2020

Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.

"None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x"

Simvastatin, Buproprion, Propranalol(low dose 10mg bid), ASA 81mg, Gabapentin 600mg, Solifenacin 5m bid, D-amphetanine, Vit D3, Advanced Memory Formula. Nurtec one tablet 01/07/2021 11am for Migraine (first time used.)

Jan., 2021

Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment.

None

Simvastatin 20mg; Finasteride 1mg; Zolpidem Tartrate 10mg; Metoprolol Tartrate 25mg; Hydrocodone 7.5/200; Cyanocobalam 1000mcg; Flomax .4mg; Timolol .5%; Daily Multivitamin; Potassium 99mg; Magnesium 1000mg; Calcium +D3 1200mg;

ANGIOGRAM RETINA

65+ years

Jan., 2021

Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment.

None

ANTICOAGULANT THERAPY

40-49 years

Dec., 2020

Onset of shortness of breath and cough on 1/3 that progressively got worse. Clinical diagnosis of pneumonia without fever was made, patient started azithromycin on 1/5 and albuterol treatments every 4-6 hrs. Initially he improved, but then worsened. chest xray on 1/6 was negative for pneumonia, PCR covid test was negative, albuterol treatment did not bring much relief. He started respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered thrombolysis and was discharged home from the ICU on 1/12 on oral anticoagulants. He is gradually improving, but very weak. He tires easily and gets a drop in oxygen to 90- 93%, as well as an increase in the heart rate to 120 when walking less than half a mile. He runs out of breath with exertion.

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

ANTINUCLEAR ANTIBODY POSITIVE

50-59 years

Dec., 2020

thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic)

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

ANTIPHOSPHOLIPID ANTIBODIES

50-59 years

Dec., 2020

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

Jan., 2021

Patient vaccinated on 1/22. The next morning (1/23), patient experienced diminished sensory and motor function in left arm and leg, as well as facial numbness. Presented to the hospital on 1/24, and was found to have a small stroke in pontine medullary junction. Discharged on 1/25. There is some suspicion that her COVID infection in December may have precipitated this, and patient is currently being evaluated for coagulation disorders, primarily antiphospholipid antibody testing. It is unlikely that the vaccine contributed to this, but given close timeline between the two, filing this report.

Patient was confirmed to be COVID positive in early December (did not require hospitalization).

Cholecalciferol daily, fish oil daily, garlic capsule daily, glucosamine daily, losartan daily, zinc daily, metformin 500 mg po daily (most doses are unclear from her medication history)

ANTIPHOSPHOLIPID ANTIBODIES NEGATIVE

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

ANTITHROMBIN III

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

ANXIETY

65+ years

Jan., 2021

Tufts of my hair came out by the handful - first time in my life I have experienced ANY hair loss! It is still ongoing and I am worried it will result in permanent baldness.

none

normal OTC vitamins, same vitamins for the last 20 years

APHASIA

50-59 years

Dec., 2020

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

65+ years

Jan., 2021

Aphasia, ,right-sided weakness and garbled speech

Sarcoidosis, Hyperlipidemia, Restless legs, Vitamin D, Insomnia, Episodic tension-type headache ,

Vitamin D2000 1 tablet qd

Seizure like episode on 1/12/21, one week after vaccine, last 1.5 hours, consisting of both eyes twitching and clenching/spasm of right hand and arm. EMS called. BP normal. Continuing weakness of right arm and right leg, which was side weakened by stroke. Could no longer stand or walk on right leg. Some slurring of speech. Some confusion. Went to hospital 1/14. No evidence of stroke or current seizure. Considered problem to be mild UTI, started antiobiotics, rapid improvement. Discharged 1/17. Woke up 1/18 with aphasia. Went to urgent care, sent immediately to hospital. Doctors found no evidence of stroke or seizure. Consider problem to be due to inflammation, caused by mild UTI (which was cleared by antibiotics) or perhaps due to inflammation caused by Covid vaccination. The inflammation reinitiated the symptoms of her stroke, although she never had expressive aphasia prior to this, only word-finding problems, which had been resolved.

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

ARTERIOSCLEROSIS

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

ARTHRALGIA

18-29 years

Jan., 2021

Severe shoulder pain, limited mobility, arm weakness still from the first day of injection (1/14) to now (1/23). Can?t adduct arm or move it side to side with out a lot of pain. If I do a wrong movement I will end up in 10/10 pain with severe aches.

Covid with symptom onset of December 20th and ending December 28th

No other medications for this event.

40-49 years

Dec., 2020

shoulder joint pain, injection was given in joint.... I am now on prednisone, physical therapy, if this doesnt help will need a MRI .

none

birth control pill,

Received Moderna COVID vaccine 12/31/20, 3 days later noticed generalized joint pain all over. Day 4 noticed both knees were red and tender and could palpate pockets of fluid. Had bilateral ankle and foot pain, right ankle swollen. Overnight 1/5-1/6/21 was in severe pain and unable to sleep, very difficult to walk on ankles and feet, stairs were very painful. Motrin relieved symptoms to where able to walk more comfortably but generalized achiness and tenderness to ankles and knees remain.

No current illness for this event.

No other medications for this event.

50-59 years

Jan., 2021

Fever, joint pain, weakness. Pain at the injection site.

covid 19 12/25/2020----12/31/2020

65+ years

Jan., 2021

AROUND 9:30 PM I BECAME VERY WEAK AND FEVERISH. I HAD CHILLS AND I COULD NOT EAT OR DRINK. I COULD NOT GET OUT OF BED TO GO TO THE BATHROOM. I THREW UP TWO DIFFERENT TIMES. THE NEXT DAY I WAS STILL VERY WEAK. I TRIED TO GET OUT OF MY CHAIR AND I FEEL. I WAS UNABLE TO GET UP WITHOUT ASSISTANCE. THE WEAKNESS AND FEVER CONTINUED FOR THE NEXT THREE DAYS. I AM STILL VERY WEAK AND CAN'T HARDLY WALK. MY HIP FLARED UP AND CAUSED ME GREAT PAIN AND IMBALANCE. ALL THE AREAS THAT I HAD OCCASSIONAL OSTEOARTHRITIS I AM NOW IN CONSTANT PAIN. I CAN NO LONGER SLEEP ON MY RIGHT SHOULDER. BOTH OF FEET FLARED UP AND HURT ALL THE TIME.

acute rt arterial ischemic stroke mca; beningn essential tremor, benign non nodular prostatic hyperplasia with loer urinary tract symptoms, benign prostratic hyperplasia, cerebral infaarcation due to embolism of vertebral artery, cvd, diabetes mellius, edema, epidiymitis right, hpercalcemia, hyperhomocystinemia, hypertension, hyporthyroidism, mixed hyperlipidemia, pfo, osteroarthritis multiple joints, scoliosis, inus bradycardia

acetaminophen, amlodipine, atorvastatin, b complex, clopidogrel, furosemide, hydrchlorothiazide, levothyroxine, losartan, meformin, multi vitamin, potassium chloride crys, primidone, tamsulosin, tramadol,

ASPIRATION

Unknown

Unknown Date

ON Jan 16 complained of lightheadedness then felt better after supper and nap. Next day ok On Jan 22 did not get up, had stroke, taken by ambulance to hospital and transferred to medical facility.

No current illness for this event.

No other medications for this event.

ASPIRATION BURSA

60-64 years

Dec., 2020

Arm weakness increased each day by post vaccine day 4 arm weak and unable to raise arm, conduct ADLs, painful interrupting sleep. Unable to initiate movement in arm. Use other arm to help move arm. Went to ED on post vaccine day 4. Wbc 12. Crp 4. CT no abscess. Mri on 1/4 shows bursitis. DX SIRVA. Bursa aspirated. Pending cultures. PO MEDROL DOSEPAK.

None

Eliquis micardis. Metoprolol crestor asa

ASTHENIA

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

50-59 years

Jan., 2021

Fever, joint pain, weakness. Pain at the injection site.

covid 19 12/25/2020----12/31/2020

65+ years

Dec., 2020

Weakness, fatigue, decreased appetite, upper extremity shaking, sternal red blotchy rash, decreased mental status, non-verbal, decreased level of conscious, mottling, left side facial droop, hypertensive, fever, unable to follow commands

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

Jan., 2021

ATRIAL FIBRILLATION

50-59 years

Jan., 2021

Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable to give history - History provided by S.O and daughter

No Acute only chronic

Multiple

AUTOANTIBODY POSITIVE

18-29 years

Sep., 2020

Complete loss of vision in the left eye 12 hours after receiving second dose (Moderna mRNA-1273) while having a fever of 102 F for 6 hours. Loss of vision lasted for 1 minute. Loss of vision occurred while standing. Referral to primary care and ophthalmology specialist found normal eye exam and MRI of orbits but presence of tachycardia especially while standing (fluctuations between 60 beats at rest/laying down to 130 beats per minute standing). Postural tachycardia syndrome (POTS) is suspected. Currently pursuing cardiac workup with cardiologist and Covid POTS specialist. POTS specialist believes autoantibody development after vaccination could be suspected as recovering covid patients similarly present to clinic with POTS like symptoms.

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

BACK PAIN

50-59 years

Jan., 2021

Moderna COVID?19 Vaccine EUA I have sciatic and have had a rhyzotomy on my right side. On 15 Jan, exactly one week after receiving the vaccine, I began to get back and leg aches from my sciatica, but on my left side. I immediately began my routine (exercise) and back brace which usually stop the pain. Over the next two day, the symptoms got worse to the point of extreme pain in my back and all down my left leg. This resulted in a trip to the emergency room on 17 January. I have since had an appointment with my pain specialist, and an MRI. We are awaiting results from the MRI. The pain has not lessened, and pain medication are only mildly effective. The pain being in my left side make since as the Rhyzotomy had been done on my right side. I am concerned the vaccine may have cause tissue or nerve swelling. Pain is still intense to the point of immobility and difficulty sleeping.

No current illness for this event.

Lisinopril, tramadol, hydrochlorothiazide, atorvastatin, doxycycline, vitamin D3, vitamin C, zinc

65+ years

Dec., 2020

I received the vaccine shot on 12/23/20 at 3 pm. By 12/24/20, I had pain in my left arm that radiated to my neck and back on the left side. Over the past 4/5 days, I continue to have pain in my left arm, back and neck

High blood pressure, cholestrol

Losarten, pravastan, B-12

Woke up Thursday am with hives on right lower abdomen and leg getting progressively worse throughout the day. By that afternoon had back pain in right back and continuing hives. Woke up Friday with numbness to right leg, hives, and back pain all on right side of body. Had numbness to foot, face but especially thigh, back and across upper buttocks. Saturday hives subsiding, numbness receding to face, upper thigh and foot only on right side of body. Sunday, back pain some improved, no hives or hives minimal, numbness persists upper thigh face and foot on right side of body. Monday, Tuesday and Wednesday the same. Woke up Thursday with shingles rash to upper thigh back, numbness to foot face and upper thigh persist only on right side of body. Darn!!!

none

Lysine, levothyroxine, B complex, Emergency C Estraidiol patch

BALANCE DISORDER

60-64 years

Dec., 2020

Woke up the next morning with slurred speech, right side weakness, illegible writing, balance issues. Next day all symptoms worse. Went to Urgent Care, was transferred to Hospital. Diagnosed with stroke.

None

Hydochlorothiazide 25 mg daily, Losartan 25 mg daily, Meloxicam 7.5 mg daily, Fexofenadine 180 mg daily, Omeprazole 40 mg daily, ALIVE womens vitamins daily, Citralcal maximum daily, Triple Flex 50+ daily, Probiotic daily.

65+ years

Jan., 2021

BETA-2 GLYCOPROTEIN ANTIBODY NEGATIVE

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

BLEPHAROSPASM

65+ years

Jan., 2021

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

BLINDNESS UNILATERAL

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

65+ years

Jan., 2021

Moderna COVID-19 Vaccine At 2 PM I went blind in my left eye. Went to emergency room at Hospital Was told I have Blood clot in my eye causing the blindness and Ophthamologist says it will probably be permanent

None

No other medications for this event.

Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment.

None

BLOOD CHOLESTEROL INCREASED

50-59 years

Dec., 2020

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

BLOOD CULTURE

18-29 years

Jan., 2021

Extreme headache, fever of 102-103 degrees farenheight, dizziness, syncopal episode at work, transferred to ER, heart rate 160s-180s, hypertensive emergency blood pressures 160s/90s. Today 1/20/2021 approx 1700.

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

BLOOD FOLATE

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

BLOOD HOMOCYSTEINE

50-59 years

Dec., 2020

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

BLOOD TEST

30-39 years

Dec., 2020

Guillain Barre syndrome/AIDP event. Paresthesia and nerve pain developed in bilateral legs 4 hours after shot and progressed slowly for 4 days in intensity and area involved. Symptoms progressed distally to superior. On the 5th day symptoms progressed rapidly and involved bilateral legs up to the groin, left arm up to lateral shoulder, and right hand. I went to the hospital and was admitted to start IVIG treatment for Guillain Barre Syndrome/AIDP.

None

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

BLOOD THYROID STIMULATING HORMONE

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

BODY TEMPERATURE INCREASED

30-39 years

Jan., 2021

Three to four hours after vaccine had bruising, major loss of range of motion, severe sharp pain, elevated temp and chills due to reaction of injection site Treatment given 24 hrs later- strong antibiotics, anti inflammatory, exercise, and three days out of work Due to loss of function of left arm due to inflammation

None

Benadryl, vitamin d, vitamin b12

BRAIN STEM INFARCTION

50-59 years

Jan., 2021

Patient was confirmed to be COVID positive in early December (did not require hospitalization).

Cholecalciferol daily, fish oil daily, garlic capsule daily, glucosamine daily, losartan daily, zinc daily, metformin 500 mg po daily (most doses are unclear from her medication history)

BURNING SENSATION

65+ years

Jan., 2021

"1. swelling, redness, heat, itching at injection site. Lasting 10 days. Peak discomfort at day 8. Hard lump, hot to touch, red, strong itch. Was 3 inches by two inches. The arm is now back to normal. .2. Day 8. Woke at roughly midnight with extreme heat and burning in all toes. Quite painful. Very unusual, as I have never experienced anything like this before. When pain and burning became overwhelming I took Tylenol. It helped and I was able to sleep. The next morning the pain and burning were gone but my toes were, and continue to be quite numb, as is the area of my feet that surrounds my toes. I can't fully feel my socks, shoes, sheets, etc. It feel like I have cotton stuffed in my shoes. It is hard for me to related the level of heat, burning and pain that happened. I felt like I could melt a block of ice with my feet. It was severe. I marked ""disability or permanent damage"" below because I don't know if the nerves in my feet will return to normal."

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

BURSITIS

18-29 years

Dec., 2020

Moderna vaccine dose #1 received in right shoulder on 12/31/20 at 2:15PM. Injection was uneventful other than sensation of pressure. I did notice at the time, but could not fully see, that the injection appeared to be much higher on the shoulder than normal. I immediately came home afterwards and relaxed. Approximately 2hrs later, I began experiencing extreme pain in my right shoulder. As the night progressed, the pain worsened to 10/10 with inability to move my arm. Later that night after requiring assistance to take off my shirt, I noticed that the bandaid overlying the injection site was very high, immediately below and bordering the acromion process. This was concerning but I was hopeful the pain would go away over the next few days. I took tylenol that night. I woke up multiple times during the night because the pain was so severe. When I woke up, the pain and inability to move my arm were still present. I began taking 800mg ibuprofen and 1000mg tylenol alternating Q4 throughout the next few days. The pain and disability remained so severe that I required assistance performing ADLs for the next 4 days. On day four, with the pain not resolved and still severe despite consistent advil and tylenol use, I began having concern for shoulder injury related to vaccine administration. The next day I decided to seek an evaluation by an orthopedist. I am a physician and was unable to perform basic tasks and ADLs. I happened to have a few days off after the injection but would not have been able to work had I not. After an evaluation by the an orthopedic PA, I obtained an MRI of my right shoulder with results shown below - as I expected evidence of rotator cuff tendinopathy and subdeltoid bursitis consistent with SIRVA. As of now, I still have limited range of motion and shoulder pain on the right which has improved slightly but is far from resolved. I still have difficulty with certain ADLs including putting clothes on and off, lifting items, and tasks that require raising my right arm above my head. I am concerned with the possibility of long term and/or permanent damage after reviewing the literature. I am also concerned about how many other healthcare workers the person who gave me my vaccine may be injuring and/or causing permanent harm to.

None

Wellbutrin

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

BUTTERFLY RASH

30-39 years

Jan., 2021

At 15 min lips began to double in size, by 30 min unable to swallow, medical personal quickly reacted and gave me a shot of steroids and shot of antihistamine. Stabilized and left. Within 24 hours severe vomiting, by 1/16 hives on face, sensitivity to light, migraine, more vomiting. Spoke with dr got prednisone, continued vomiting, 1/19 spoke to PCP Got higher dose of steroids for hives and 8 mg zofran. 1/20-1/22 developed butterfly rash on face similar to lupus. Prescribed more steroids and Ativan to sleep. Follow up scheduled for two weeks

None

Benadryl welbutrin

C-REACTIVE PROTEIN INCREASED

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

CARDIOLIPIN ANTIBODY NEGATIVE

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

CEREBELLAR STROKE

50-59 years

Jan., 2021

"1/6/21 5:30 pm Client was as her patients house and stood up to leave and was ""walking like I was drunk."" Felt like her leg was asleep. Got to her car and drove to next patients house. Noticed Rt. sided weakness and knee buckling. Drove herself home and went to bed. 1/7/21 Woke up to increased symptoms, Rt hand and Rt. leg weak, slurring speech. hospital by rescue. Admitted X 7 days. CT SCAN with and without contrast showed no bleed. Telemed Visit, MD ordered MRI to rule out Cerebellum Stroke. MRI showed cerebellum stroke. Transferred to A Rehabilitation X 7 days. Has regained most of her normal functions, continues outpatient therapy."

None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started

Crestor, Lisinopril, Glimepiride, Eliquis, Metformin

CEREBRAL ARTERY EMBOLISM

30-39 years

Jan., 2021

Patient states he started having sudden onset of left facial droop, left-sided arm and leg 15 minutes prior to arrival on 1/23 while driving. Pt got the Moderna vaccine second dose 2 days ago (1/21). Patient denies any history of stroke, DVT, PE. tPA was administered. Found to have clot in the Right MCA territory and taken for mechanical thrombectomy to remove the clot. Patient remains hospitalized and further workup is going.

None known

desogestreL-ethinyl estradioL (Enskyce) 0.15-0.03 mg per tablet, escitalopram (LEXAPRO) 20 MG tablet, spironolactone (ALDACTONE) 100 MG tablet

CEREBRAL HAEMORRHAGE

50-59 years

Jan., 2021

Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable to give history - History provided by S.O and daughter

No Acute only chronic

Multiple

65+ years

Jan., 2021

After 1.5-2 hours after injection, patient blacked out on stairwell and fell down stairs. Patient struck head and received a concussion, broken nose, brain bleed, tear in the lip and damage to 6th cranial nerve in right eye. Patient has double vision now.

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

CEREBROVASCULAR ACCIDENT

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

50-59 years

Jan., 2021

Patient was confirmed to be COVID positive in early December (did not require hospitalization).

Cholecalciferol daily, fish oil daily, garlic capsule daily, glucosamine daily, losartan daily, zinc daily, metformin 500 mg po daily (most doses are unclear from her medication history)

60-64 years

Dec., 2020

None

Jan., 2021

Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA

No current illness for this event.

lipitor asa glipizide coreg losartan

65+ years

Jan., 2021

Aphasia, ,right-sided weakness and garbled speech

Sarcoidosis, Hyperlipidemia, Restless legs, Vitamin D, Insomnia, Episodic tension-type headache ,

Vitamin D2000 1 tablet qd

Felt strange 5 days after getting shot, weakness in legs, fatigued. Next day started having slurred speech, weakness in bil lower ext.

None

Amlodipine 5 mg q day, Toujeo pen 30 to 60 Units at HS, Glimperde 4 mg q day PRN, ASA 325 mg q day, Vit D3 2000 IUs q day, Vit C 500 mg q day, Vit B12 1000 mcg q day, Folate 400 mcg q day

Unknown

Unknown Date

ON Jan 16 complained of lightheadedness then felt better after supper and nap. Next day ok On Jan 22 did not get up, had stroke, taken by ambulance to hospital and transferred to medical facility.

No current illness for this event.

No other medications for this event.

CHEST PAIN

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

CHEST X-RAY

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.

"None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x"

CHEST X-RAY NORMAL

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

CHILLS

30-39 years

Jan., 2021

None

Benadryl, vitamin d, vitamin b12

65+ years

Jan., 2021

COAGULATION TEST

50-59 years

Jan., 2021

Patient was confirmed to be COVID positive in early December (did not require hospitalization).

Cholecalciferol daily, fish oil daily, garlic capsule daily, glucosamine daily, losartan daily, zinc daily, metformin 500 mg po daily (most doses are unclear from her medication history)

COAGULATION TIME

50-59 years

Dec., 2020

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

COGNITIVE DISORDER

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

COMPLICATED APPENDICITIS

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

COMPUTERISED TOMOGRAM

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

Jan., 2021

Approximately 28 hours after vaccine, I began to feel tingling in my right eye Approximately 12 hours after that, my face started drooping and was numb so I went to ER. Today is Sunday, and the numbness and drooping was called Bells Palsy at the hospital.

None

Synthroid Vitamin d Lisinopril hctz Lipitor Multivitamin

50-59 years

Jan., 2021

Bell's palsy

none

Metformin, Atorvastatin, Losartan, Atenolol/Chlorthalidone, ASA, Glucosamine Chondroitin,Fish Oil,Pepcid

60-64 years

Dec., 2020

None

65+ years

Jan., 2021

None

No other medications for this event.

Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment.

None

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

COMPUTERISED TOMOGRAM ABDOMEN

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

COMPUTERISED TOMOGRAM ABNORMAL

65+ years

Dec., 2020

Hemmoragic Stroke. Began with vision difficulty in the morning. Then I noticed she had left sided neglect. Went to ER. Treated with Andresxa (to counteract Elaquis). In SICU for 2 nights then telemetry unit for 3 nights. CUrrently in Rehab.

high bp, high cholesterol,

Elequis, Amiodoron, pravastatin, losartin, synthroid, timalol

COMPUTERISED TOMOGRAM CORONARY ARTERY

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

COMPUTERISED TOMOGRAM HEAD

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

COMPUTERISED TOMOGRAM HEAD ABNORMAL

30-39 years

Jan., 2021

None known

desogestreL-ethinyl estradioL (Enskyce) 0.15-0.03 mg per tablet, escitalopram (LEXAPRO) 20 MG tablet, spironolactone (ALDACTONE) 100 MG tablet

65+ years

Jan., 2021

Right arm weakness 2 hrs after vaccine and then right leg weakness later that evening

none

Aspirin, Lipitor,Zyrtec, Klonopin, cranberry tab, mucinex, famotidine, Flonase, Lactase, lactobacillus, synthroid, mirtazapine, nitrofurantoin, fish oil, pro tonic, potassium, propranolol, carafate, trazodone

Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.

None

Morning: Lexapro 10 mg, Losartan/HCT 100/12.5/, atoruastatin 20 mg/calcium, Escital Opram 5mg, Evening: omaprazole 20 mg, procilosac, amlicdpine destylate 5 mg, montelakast sodium 10 mg, baby asprin Day and night: dymista 23 mg spray, Tro

COMPUTERISED TOMOGRAM HEAD NORMAL

65+ years

Jan., 2021

Felt strange 5 days after getting shot, weakness in legs, fatigued. Next day started having slurred speech, weakness in bil lower ext.

None

Amlodipine 5 mg q day, Toujeo pen 30 to 60 Units at HS, Glimperde 4 mg q day PRN, ASA 325 mg q day, Vit D3 2000 IUs q day, Vit C 500 mg q day, Vit B12 1000 mcg q day, Folate 400 mcg q day

COMPUTERISED TOMOGRAM NORMAL

18-29 years

Jan., 2021

Jan 11-vaccination day. On Jan 14, in afternoon had tinnitus and muffled hearing that went away. The next morning Jan15, complete sudden hearing loss on left ear. Tinnitus and muffled hearing that has not went away.

None (Not an illness, but was on Keto diet over a month ago)

Vitamin C

50-59 years

Jan., 2021

None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started

Crestor, Lisinopril, Glimepiride, Eliquis, Metformin

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

COMPUTERISED TOMOGRAM THORAX

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

65+ years

Dec., 2020

Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.

"None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x"

COMPUTERISED TOMOGRAM THORAX ABNORMAL

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

CONCUSSION

65+ years

Jan., 2021

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

CONDITION AGGRAVATED

40-49 years

Dec., 2020

severe tinnitus and loss of hearing as some tones. persistent since day after vaccination and continuing through time of reporting to VAERS.

none

lisinopril 40mg, vitamin d3, cetirizine 10mg

50-59 years

Jan., 2021

No current illness for this event.

Lisinopril, tramadol, hydrochlorothiazide, atorvastatin, doxycycline, vitamin D3, vitamin C, zinc

65+ years

Jan., 2021

CONFUSIONAL STATE

65+ years

Jan., 2021

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

CONTUSION

30-39 years

Jan., 2021

None

Benadryl, vitamin d, vitamin b12

COUGH

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

CRANIAL NERVE INJURY

65+ years

Jan., 2021

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

CRANIOTOMY

50-59 years

Dec., 2020

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

CULTURE

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

DEAFNESS

18-29 years

Jan., 2021

None (Not an illness, but was on Keto diet over a month ago)

Vitamin C

40-49 years

Dec., 2020

severe tinnitus and loss of hearing as some tones. persistent since day after vaccination and continuing through time of reporting to VAERS.

none

lisinopril 40mg, vitamin d3, cetirizine 10mg

DEAFNESS NEUROSENSORY

18-29 years

Dec., 2020

sudden sensorineural hearing loss in the right ear, audiology and ENT assessment, currently being treated with steroid medication

none

loloestrin

65+ years

Jan., 2021

None

Eplerenone, Metoprolol, Digestive Advantage Lactose Defense, D3,B12, Biotin, Potassium

DEAFNESS UNILATERAL

18-29 years

Jan., 2021

None (Not an illness, but was on Keto diet over a month ago)

Vitamin C

30-39 years

Dec., 2020

Sudden hearing loss right ear accompanied by tinnitus

No current illness for this event.

Levothyroxine

Sudden hearing loss right arm accompanied by tinnitus

No current illness for this event.

Levothyroxin

65+ years

Jan., 2021

None

Eplerenone, Metoprolol, Digestive Advantage Lactose Defense, D3,B12, Biotin, Potassium

DECREASED APPETITE

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

DEEP VEIN THROMBOSIS

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

DEPRESSED LEVEL OF CONSCIOUSNESS

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

DIARRHOEA

18-29 years

Jan., 2021

I received the vaccine on 1/19/2021 at my place of employment. Upon getting the vaccine approx 30 minutes after receiving i became very itcy, and my lips were burning/tingling. The itching continued to get worse, forming red rash on my chest. I called my MD at this point. I was told to take benadryl and to go to er if it became worse. I took benadryl. the itching continued for 2 days. i also experienced pain at injection site, headache, nausea, diarrhea, extreme fatigue, muscle soreness. on 2nd day after vaccine i woke up and my muscles continued to be very sore. like i had just completed a marathon. I also have this sensation that started with the increased muscle pain. The only way i can explain it is that it feels like how a TENS unit feels, but its coming from the inside. especially in my back and thighs. this continues. i feel like i could just start shaking at any time. i cannot sleep but i am so tired. i was seen at dr today and i was told to report this to you guys. this sensation has not went away and has actually cause my muscles to spasming. MD said the vaccine effected my muscles and possibly neurologically as well.

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

DIPLOPIA

65+ years

Jan., 2021

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

DISORIENTATION

50-59 years

Jan., 2021

Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable to give history - History provided by S.O and daughter

No Acute only chronic

Multiple

DIZZINESS

18-29 years

Jan., 2021

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

50-59 years

Jan., 2021

Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable to give history - History provided by S.O and daughter

No Acute only chronic

Multiple

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

65+ years

Jan., 2021

Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.

None

Unknown

Unknown Date

ON Jan 16 complained of lightheadedness then felt better after supper and nap. Next day ok On Jan 22 did not get up, had stroke, taken by ambulance to hospital and transferred to medical facility.

No current illness for this event.

No other medications for this event.

DROOLING

60-64 years

Jan., 2021

Morning of 1/24/21 (Sunday), patient saw that the right side of her face was drooping, her right eye was swollen and excessively tearing. Patient noted drooling out of the right side of mouth when drinking fluids or eating food. Patient was unable to chew on the right side, had difficulty speaking due to the drooping of the right side of her mouth. Symptoms persisted into the next day. Patient was seen by her PCP and was diagnosed with Facial Palsy (Bell's Palsy). Patient's neurological assessment was negative for stroke symptoms.

No current illness for this event.

Metformin 1000 mg BID Glimepiride 2 mg once a day Januvia 100 mg once a day Losartan 25 mg once a day Atorvastatin 20 mg once a day Levocetirizine 5 mg once a day Vitamin D Multivitamins Calcium Vitamin C Glucosamine Vitamin B12 Tumeric

DYSARTHRIA

50-59 years

Jan., 2021

None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started

Crestor, Lisinopril, Glimepiride, Eliquis, Metformin

60-64 years

Dec., 2020

None

Jan., 2021

Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA

No current illness for this event.

lipitor asa glipizide coreg losartan

65+ years

Jan., 2021

Aphasia, ,right-sided weakness and garbled speech

Sarcoidosis, Hyperlipidemia, Restless legs, Vitamin D, Insomnia, Episodic tension-type headache ,

Vitamin D2000 1 tablet qd

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

Felt strange 5 days after getting shot, weakness in legs, fatigued. Next day started having slurred speech, weakness in bil lower ext.

None

Amlodipine 5 mg q day, Toujeo pen 30 to 60 Units at HS, Glimperde 4 mg q day PRN, ASA 325 mg q day, Vit D3 2000 IUs q day, Vit C 500 mg q day, Vit B12 1000 mcg q day, Folate 400 mcg q day

DYSGRAPHIA

60-64 years

Dec., 2020

None

DYSPHAGIA

30-39 years

Jan., 2021

None

Benadryl welbutrin

40-49 years

Dec., 2020

20 minutes post injection- generalized redness of skin, felt hot and flushed. 25 minutes - tachycardia heart rate. Went from 60?s to 120?s. 30 minutes- difficulty swallowing and hypoxia @ 90

None

NP Thyroid 90mg daily vitamin D3 10,000 daily Vitamin C 2000 daily Progesterone 100mg HS

DYSPNOEA

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

DYSPNOEA EXERTIONAL

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

DYSSTASIA

50-59 years

Jan., 2021

None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started

Crestor, Lisinopril, Glimepiride, Eliquis, Metformin

65+ years

Jan., 2021

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

EAR DISCOMFORT

65+ years

Jan., 2021

None

Eplerenone, Metoprolol, Digestive Advantage Lactose Defense, D3,B12, Biotin, Potassium

ECHOCARDIOGRAM

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

65+ years

Dec., 2020

Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.

"None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x"

ELECTROCARDIOGRAM

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

Jan., 2021

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

65+ years

Dec., 2020

Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.

"None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x"

Jan., 2021

Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment.

None

ELECTROCARDIOGRAM AMBULATORY

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

ELECTROENCEPHALOGRAM

65+ years

Dec., 2020

Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.

"None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x"

EPSTEIN-BARR VIRUS ANTIBODY

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

ERYTHEMA

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

20 minutes post injection- generalized redness of skin, felt hot and flushed. 25 minutes - tachycardia heart rate. Went from 60?s to 120?s. 30 minutes- difficulty swallowing and hypoxia @ 90

None

NP Thyroid 90mg daily vitamin D3 10,000 daily Vitamin C 2000 daily Progesterone 100mg HS

EXPOSURE DURING PREGNANCY

18-29 years

Jan., 2021

I was pregnant and my baby died two days after I took it and I got really sick

None

EXTERNAL EAR PAIN

65+ years

Jan., 2021

Left side of face paralysis. Unable to close left eye or move any muscles on left side of face , and pain behind left ear . Diagnosed by family practitioner as Bells Palsy

No current illness for this event.

Heart medications and respiratory inhalers

EYE MOVEMENT DISORDER

65+ years

Jan., 2021

Left side of face paralysis. Unable to close left eye or move any muscles on left side of face , and pain behind left ear . Diagnosed by family practitioner as Bells Palsy

No current illness for this event.

Heart medications and respiratory inhalers

EYE SWELLING

60-64 years

Jan., 2021

No current illness for this event.

FACIAL BONES FRACTURE

65+ years

Jan., 2021

Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.

None

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

FACIAL PARALYSIS

30-39 years

Jan., 2021

None known

desogestreL-ethinyl estradioL (Enskyce) 0.15-0.03 mg per tablet, escitalopram (LEXAPRO) 20 MG tablet, spironolactone (ALDACTONE) 100 MG tablet

40-49 years

Jan., 2021

None

Synthroid Vitamin d Lisinopril hctz Lipitor Multivitamin

50-59 years

Dec., 2020

Bell?s palsy

HTN. Hypertriglycerademia; gout

Allopurinol; amlodipine; hydrochlorothiazide; lisinopril; atorvastatin

Jan., 2021

Bell's palsy

none

Metformin, Atorvastatin, Losartan, Atenolol/Chlorthalidone, ASA, Glucosamine Chondroitin,Fish Oil,Pepcid

60-64 years

Jan., 2021

No current illness for this event.

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

Jan., 2021

Left side of face paralysis. Unable to close left eye or move any muscles on left side of face , and pain behind left ear . Diagnosed by family practitioner as Bells Palsy

No current illness for this event.

Heart medications and respiratory inhalers

FACIAL PARESIS

65+ years

Jan., 2021

Left side of face paralysis. Unable to close left eye or move any muscles on left side of face , and pain behind left ear . Diagnosed by family practitioner as Bells Palsy

No current illness for this event.

Heart medications and respiratory inhalers

FALL

65+ years

Jan., 2021

Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.

None

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

FATIGUE

18-29 years

Jan., 2021

Extreme fatigue since getting shot - effecting ability to work

None

Xyzal (occationally) multivitamin

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

Jan., 2021

Felt strange 5 days after getting shot, weakness in legs, fatigued. Next day started having slurred speech, weakness in bil lower ext.

None

Amlodipine 5 mg q day, Toujeo pen 30 to 60 Units at HS, Glimperde 4 mg q day PRN, ASA 325 mg q day, Vit D3 2000 IUs q day, Vit C 500 mg q day, Vit B12 1000 mcg q day, Folate 400 mcg q day

FEEDING DISORDER

65+ years

Jan., 2021

FEELING ABNORMAL

65+ years

Jan., 2021

Felt strange 5 days after getting shot, weakness in legs, fatigued. Next day started having slurred speech, weakness in bil lower ext.

None

Amlodipine 5 mg q day, Toujeo pen 30 to 60 Units at HS, Glimperde 4 mg q day PRN, ASA 325 mg q day, Vit D3 2000 IUs q day, Vit C 500 mg q day, Vit B12 1000 mcg q day, Folate 400 mcg q day

FEELING HOT

40-49 years

Dec., 2020

20 minutes post injection- generalized redness of skin, felt hot and flushed. 25 minutes - tachycardia heart rate. Went from 60?s to 120?s. 30 minutes- difficulty swallowing and hypoxia @ 90

None

NP Thyroid 90mg daily vitamin D3 10,000 daily Vitamin C 2000 daily Progesterone 100mg HS

65+ years

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

FIBRIN D DIMER INCREASED

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

FLUID RETENTION

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

FLUSHING

40-49 years

Dec., 2020

20 minutes post injection- generalized redness of skin, felt hot and flushed. 25 minutes - tachycardia heart rate. Went from 60?s to 120?s. 30 minutes- difficulty swallowing and hypoxia @ 90

None

NP Thyroid 90mg daily vitamin D3 10,000 daily Vitamin C 2000 daily Progesterone 100mg HS

FOETAL DEATH

18-29 years

Jan., 2021

I was pregnant and my baby died two days after I took it and I got really sick

None

FULL BLOOD COUNT

18-29 years

Jan., 2021

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

FULL BLOOD COUNT NORMAL

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

GAIT DISTURBANCE

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

50-59 years

Jan., 2021

None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started

Crestor, Lisinopril, Glimepiride, Eliquis, Metformin

65+ years

Jan., 2021

GAIT INABILITY

65+ years

Jan., 2021

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

GUILLAIN-BARRE SYNDROME

30-39 years

Dec., 2020

None

HAEMORRHAGIC STROKE

65+ years

Dec., 2020

high bp, high cholesterol,

Elequis, Amiodoron, pravastatin, losartin, synthroid, timalol

HEAD INJURY

65+ years

Jan., 2021

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

HEAD TITUBATION

40-49 years

Jan., 2021

Approximately 3 days after my injection I began experience severe tremors Ib bilateral arms, bilateral legs, head, and vocal cord tremors as well as blurry vision and memory impairment. Unfortunately, the symptoms don't seem to be improving. My MD prescribed metoprolol, which I will begin today.

No current illness for this event.

No other medications for this event.

HEADACHE

18-29 years

Jan., 2021

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

HEART RATE INCREASED

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

HEART RATE IRREGULAR

Unknown

Unknown Date

ON Jan 16 complained of lightheadedness then felt better after supper and nap. Next day ok On Jan 22 did not get up, had stroke, taken by ambulance to hospital and transferred to medical facility.

No current illness for this event.

No other medications for this event.

HEMIPARESIS

30-39 years

Jan., 2021

None known

desogestreL-ethinyl estradioL (Enskyce) 0.15-0.03 mg per tablet, escitalopram (LEXAPRO) 20 MG tablet, spironolactone (ALDACTONE) 100 MG tablet

50-59 years

Jan., 2021

None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started

Crestor, Lisinopril, Glimepiride, Eliquis, Metformin

60-64 years

Dec., 2020

None

Jan., 2021

Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA

No current illness for this event.

lipitor asa glipizide coreg losartan

65+ years

Jan., 2021

Right arm weakness 2 hrs after vaccine and then right leg weakness later that evening

none

Aphasia, ,right-sided weakness and garbled speech

Sarcoidosis, Hyperlipidemia, Restless legs, Vitamin D, Insomnia, Episodic tension-type headache ,

Vitamin D2000 1 tablet qd

HERPES OPHTHALMIC

40-49 years

Dec., 2020

Herpatic infection left eye causing a herpatic dendrite

None

Lisinopril, metoprolol, eliquis, multivitamin

HERPES ZOSTER

65+ years

Dec., 2020

none

Lysine, levothyroxine, B complex, Emergency C Estraidiol patch

HYPERCOAGULATION

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

HYPERTENSION

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

HYPERTENSIVE EMERGENCY

18-29 years

Jan., 2021

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

HYPOACUSIS

18-29 years

Jan., 2021

None (Not an illness, but was on Keto diet over a month ago)

Vitamin C

65+ years

Jan., 2021

None

Eplerenone, Metoprolol, Digestive Advantage Lactose Defense, D3,B12, Biotin, Potassium

HYPOAESTHESIA

40-49 years

Jan., 2021

None

Synthroid Vitamin d Lisinopril hctz Lipitor Multivitamin

50-59 years

Jan., 2021

None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started

Crestor, Lisinopril, Glimepiride, Eliquis, Metformin

Patient was confirmed to be COVID positive in early December (did not require hospitalization).

Cholecalciferol daily, fish oil daily, garlic capsule daily, glucosamine daily, losartan daily, zinc daily, metformin 500 mg po daily (most doses are unclear from her medication history)

65+ years

Dec., 2020

none

Lysine, levothyroxine, B complex, Emergency C Estraidiol patch

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

HYPOXIA

40-49 years

Dec., 2020

20 minutes post injection- generalized redness of skin, felt hot and flushed. 25 minutes - tachycardia heart rate. Went from 60?s to 120?s. 30 minutes- difficulty swallowing and hypoxia @ 90

None

NP Thyroid 90mg daily vitamin D3 10,000 daily Vitamin C 2000 daily Progesterone 100mg HS

IMMUNOGLOBULIN THERAPY

30-39 years

Dec., 2020

None

IMPAIRED DRIVING ABILITY

50-59 years

Dec., 2020

decreased range of motion in vaccinated arm: unable to raise left arm above shoulder x 72 hours now due to pain. no associated numbness or swelling. I am a surgeon and this impacts my work and driving. I would not have been able to operate during these last 3 days and while the pain is better 72hrs later, my arm is still out of commission. I think we need to inform healthcare providers who perform procedures that they may want to schedule the vaccine when no planned procedures for at least 72 hrs. Due to this issue I will be unable to proceed with the second dose, unless I can take it a week later than the scheduled January 24, 2021. It is taking too long to regain full function of the arm but i expect it will be back to normal as it is better today 72 hrs later.

none

minasterin oral contraceptive

IMPAIRED WORK ABILITY

18-29 years

Jan., 2021

Extreme fatigue since getting shot - effecting ability to work

None

Xyzal (occationally) multivitamin

30-39 years

Jan., 2021

None

Benadryl, vitamin d, vitamin b12

50-59 years

Dec., 2020

none

minasterin oral contraceptive

INFLAMMATION

30-39 years

Jan., 2021

None

Benadryl, vitamin d, vitamin b12

65+ years

Jan., 2021

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

INJECTED LIMB MOBILITY DECREASED

18-29 years

Dec., 2020

None

Wellbutrin

30-39 years

Jan., 2021

I was injected high on my shoulder, significantly higher than I?ve ever been injected in my life. I believe I have SIRVA. The pain has become so severe that I cannot use my left arm. The pain is intolerable. I take four Advil every six hours, ice my arm regularly, and keep my arm in a sling. The pain has gotten significantly worse with time (not better). I?ve never experienced pain like this from a vaccine in my life. No history of bursitis or shoulder injury. Again, the pain gets worse with time. I?m almost 48 hours post injection

None

50-59 years

Dec., 2020

none

minasterin oral contraceptive

60-64 years

Jan., 2021

Injection given without unusual pain, but appeared to be at higher site than usual for other vaccinations patient has received. No immediate reactions. No redness or swelling at injection site. Approximately 3 hours later with restriction of abduction of left arm, which became worse over 24 hours. No numbnness, pain 4-5/10 diffusely over deltoid and in acromium, posterior suprascapular area.. Able to passively move arm, treated with topical Voltaren gel, Naproxyn 500 x 1 dose. D2 with increased ROM, but still restricted.

UTI

Felodipine, Zetia, Crestor, Toporol XL, Repatha, Vit D, B, Ma

INJECTION SITE DISCOMFORT

18-29 years

Dec., 2020

None

Wellbutrin

INJECTION SITE ERYTHEMA

65+ years

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

INJECTION SITE MASS

65+ years

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

INJECTION SITE PAIN

18-29 years

Dec., 2020

None

Wellbutrin

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

50-59 years

Jan., 2021

Fever, joint pain, weakness. Pain at the injection site.

covid 19 12/25/2020----12/31/2020

INJECTION SITE PRURITUS

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

65+ years

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

INJECTION SITE REACTION

30-39 years

Jan., 2021

None

Benadryl, vitamin d, vitamin b12

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

INJECTION SITE SWELLING

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

65+ years

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

INJECTION SITE WARMTH

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

65+ years

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

INSOMNIA

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

INTENSIVE CARE

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

65+ years

Dec., 2020

high bp, high cholesterol,

Elequis, Amiodoron, pravastatin, losartin, synthroid, timalol

JOINT RANGE OF MOTION DECREASED

30-39 years

Jan., 2021

None

Benadryl, vitamin d, vitamin b12

JOINT SWELLING

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

LABORATORY TEST

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

Jan., 2021

None

Synthroid Vitamin d Lisinopril hctz Lipitor Multivitamin

50-59 years

Jan., 2021

Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable to give history - History provided by S.O and daughter

No Acute only chronic

Multiple

Bell's palsy

none

Metformin, Atorvastatin, Losartan, Atenolol/Chlorthalidone, ASA, Glucosamine Chondroitin,Fish Oil,Pepcid

60-64 years

Dec., 2020

None

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

LACRIMATION INCREASED

60-64 years

Jan., 2021

No current illness for this event.

LARYNGEAL TREMOR

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

LIP INJURY

65+ years

Jan., 2021

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

LIP SWELLING

30-39 years

Jan., 2021

None

Benadryl welbutrin

LIPASE NORMAL

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

LIVEDO RETICULARIS

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

LOCALISED OEDEMA

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

LOSS OF CONSCIOUSNESS

65+ years

Jan., 2021

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES

18-29 years

Dec., 2020

None

Wellbutrin

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

LOW DENSITY LIPOPROTEIN INCREASED

50-59 years

Dec., 2020

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

MAGNETIC RESONANCE IMAGING

30-39 years

Dec., 2020

None

40-49 years

Jan., 2021

None

Synthroid Vitamin d Lisinopril hctz Lipitor Multivitamin

50-59 years

Jan., 2021

No current illness for this event.

Lisinopril, tramadol, hydrochlorothiazide, atorvastatin, doxycycline, vitamin D3, vitamin C, zinc

Patient was confirmed to be COVID positive in early December (did not require hospitalization).

Cholecalciferol daily, fish oil daily, garlic capsule daily, glucosamine daily, losartan daily, zinc daily, metformin 500 mg po daily (most doses are unclear from her medication history)

60-64 years

Dec., 2020

None

65+ years

Jan., 2021

Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment.

None

MAGNETIC RESONANCE IMAGING ABNORMAL

18-29 years

Dec., 2020

None

Wellbutrin

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

MAGNETIC RESONANCE IMAGING BRAIN

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

65+ years

Dec., 2020

Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.

"None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x"

Jan., 2021

Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D

MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL

30-39 years

Jan., 2021

None known

desogestreL-ethinyl estradioL (Enskyce) 0.15-0.03 mg per tablet, escitalopram (LEXAPRO) 20 MG tablet, spironolactone (ALDACTONE) 100 MG tablet

50-59 years

Jan., 2021

None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started

Crestor, Lisinopril, Glimepiride, Eliquis, Metformin

65+ years

Jan., 2021

Aphasia, ,right-sided weakness and garbled speech

Sarcoidosis, Hyperlipidemia, Restless legs, Vitamin D, Insomnia, Episodic tension-type headache ,

Vitamin D2000 1 tablet qd

Felt strange 5 days after getting shot, weakness in legs, fatigued. Next day started having slurred speech, weakness in bil lower ext.

None

Amlodipine 5 mg q day, Toujeo pen 30 to 60 Units at HS, Glimperde 4 mg q day PRN, ASA 325 mg q day, Vit D3 2000 IUs q day, Vit C 500 mg q day, Vit B12 1000 mcg q day, Folate 400 mcg q day

MAGNETIC RESONANCE IMAGING NECK

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

MALAISE

18-29 years

Jan., 2021

I was pregnant and my baby died two days after I took it and I got really sick

None

MASTICATION DISORDER

60-64 years

Jan., 2021

No current illness for this event.

MECHANICAL VENTILATION

50-59 years

Dec., 2020

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

MEMORY IMPAIRMENT

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

MENTAL STATUS CHANGES

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

METABOLIC FUNCTION TEST

18-29 years

Jan., 2021

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

METABOLIC FUNCTION TEST NORMAL

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

MIGRAINE

30-39 years

Jan., 2021

None

Benadryl welbutrin

MOBILITY DECREASED

18-29 years

Jan., 2021

Covid with symptom onset of December 20th and ending December 28th

No other medications for this event.

50-59 years

Jan., 2021

No current illness for this event.

Lisinopril, tramadol, hydrochlorothiazide, atorvastatin, doxycycline, vitamin D3, vitamin C, zinc

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

65+ years

Jan., 2021

MUSCLE SPASMS

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

65+ years

Jan., 2021

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

MUSCLE TWITCHING

65+ years

Dec., 2020

Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.

"None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x"

MUSCULAR WEAKNESS

18-29 years

Jan., 2021

Covid with symptom onset of December 20th and ending December 28th

No other medications for this event.

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

65+ years

Jan., 2021

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

Felt strange 5 days after getting shot, weakness in legs, fatigued. Next day started having slurred speech, weakness in bil lower ext.

None

Amlodipine 5 mg q day, Toujeo pen 30 to 60 Units at HS, Glimperde 4 mg q day PRN, ASA 325 mg q day, Vit D3 2000 IUs q day, Vit C 500 mg q day, Vit B12 1000 mcg q day, Folate 400 mcg q day

MUSCULOSKELETAL DISORDER

30-39 years

Jan., 2021

None

Benadryl, vitamin d, vitamin b12

MYALGIA

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

65+ years

Dec., 2020

Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.

"None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x"

NAUSEA

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

65+ years

Jan., 2021

Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.

None

NECK PAIN

65+ years

Dec., 2020

High blood pressure, cholestrol

Losarten, pravastan, B-12

NEURALGIA

30-39 years

Dec., 2020

None

NEUROLOGIC NEGLECT SYNDROME

65+ years

Dec., 2020

high bp, high cholesterol,

Elequis, Amiodoron, pravastatin, losartin, synthroid, timalol

NEUROLOGICAL EXAMINATION

30-39 years

Dec., 2020

None

60-64 years

Dec., 2020

None

65+ years

Jan., 2021

None

No other medications for this event.

NEUROLOGICAL EXAMINATION NORMAL

60-64 years

Jan., 2021

No current illness for this event.

OEDEMA PERIPHERAL

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

OPHTHALMIC HERPES SIMPLEX

40-49 years

Dec., 2020

Herpatic infection left eye causing a herpatic dendrite

None

Lisinopril, metoprolol, eliquis, multivitamin

OPHTHALMOLOGICAL EXAMINATION

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

40-49 years

Dec., 2020

Herpatic infection left eye causing a herpatic dendrite

None

Lisinopril, metoprolol, eliquis, multivitamin

65+ years

Jan., 2021

None

No other medications for this event.

ORAL DISCOMFORT

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

OSTEOARTHRITIS

65+ years

Jan., 2021

OXYGEN SATURATION DECREASED

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

PAIN

18-29 years

Jan., 2021

Covid with symptom onset of December 20th and ending December 28th

No other medications for this event.

30-39 years

Jan., 2021

None

Benadryl, vitamin d, vitamin b12

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

none

minasterin oral contraceptive

65+ years

Dec., 2020

High blood pressure, cholestrol

Losarten, pravastan, B-12

PAIN IN EXTREMITY

30-39 years

Jan., 2021

None

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

Jan., 2021

No current illness for this event.

Lisinopril, tramadol, hydrochlorothiazide, atorvastatin, doxycycline, vitamin D3, vitamin C, zinc

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

Jan., 2021

UTI

Felodipine, Zetia, Crestor, Toporol XL, Repatha, Vit D, B, Ma

65+ years

Dec., 2020

High blood pressure, cholestrol

Losarten, pravastan, B-12

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

PANIC ATTACK

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

PARAESTHESIA

30-39 years

Dec., 2020

None

40-49 years

Jan., 2021

None

Synthroid Vitamin d Lisinopril hctz Lipitor Multivitamin

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

PARAESTHESIA ORAL

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

PERIPHERAL SENSORIMOTOR NEUROPATHY

50-59 years

Jan., 2021

Patient was confirmed to be COVID positive in early December (did not require hospitalization).

Cholecalciferol daily, fish oil daily, garlic capsule daily, glucosamine daily, losartan daily, zinc daily, metformin 500 mg po daily (most doses are unclear from her medication history)

PHOTOPHOBIA

30-39 years

Jan., 2021

None

Benadryl welbutrin

PNEUMONIA

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

PRODUCT ADMINISTERED AT INAPPROPRIATE SITE

30-39 years

Jan., 2021

None

40-49 years

Dec., 2020

shoulder joint pain, injection was given in joint.... I am now on prednisone, physical therapy, if this doesnt help will need a MRI .

none

birth control pill,

60-64 years

Jan., 2021

UTI

Felodipine, Zetia, Crestor, Toporol XL, Repatha, Vit D, B, Ma

PROTEIN C

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

PROTEIN S NORMAL

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

PRURITUS

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

PULMONARY EMBOLISM

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

PULMONARY FUNCTION TEST

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

PYREXIA

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

Jan., 2021

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

50-59 years

Jan., 2021

Fever, joint pain, weakness. Pain at the injection site.

covid 19 12/25/2020----12/31/2020

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

Jan., 2021

RASH

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

none

Lysine, levothyroxine, B complex, Emergency C Estraidiol patch

RASH ERYTHEMATOUS

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

RASH MACULAR

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

RED BLOOD CELL SEDIMENTATION RATE

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

RED BLOOD CELL SEDIMENTATION RATE NORMAL

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

RENAL CYST

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

RESPIRATORY DISTRESS

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

RETINAL ARTERY OCCLUSION

65+ years

Jan., 2021

Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment.

None

SARS-COV-2 ANTIBODY TEST NEGATIVE

65+ years

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

SARS-COV-2 TEST

18-29 years

Jan., 2021

I was pregnant and my baby died two days after I took it and I got really sick

None

SARS-COV-2 TEST NEGATIVE

18-29 years

Jan., 2021

Extreme fatigue since getting shot - effecting ability to work

None

Xyzal (occationally) multivitamin

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

SCAN WITH CONTRAST

40-49 years

Dec., 2020

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

None

SCAN WITH CONTRAST ABNORMAL

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

SCAN WITH CONTRAST NORMAL

50-59 years

Jan., 2021

None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started

Crestor, Lisinopril, Glimepiride, Eliquis, Metformin

SCIATICA

50-59 years

Jan., 2021

No current illness for this event.

Lisinopril, tramadol, hydrochlorothiazide, atorvastatin, doxycycline, vitamin D3, vitamin C, zinc

SEIZURE LIKE PHENOMENA

65+ years

Jan., 2021

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

SENSORY DISTURBANCE

18-29 years

Jan., 2021

none

Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,

65+ years

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION

18-29 years

Dec., 2020

None

Wellbutrin

30-39 years

Jan., 2021

None

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

SLEEP DISORDER

18-29 years

Dec., 2020

None

Wellbutrin

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

50-59 years

Jan., 2021

No current illness for this event.

Lisinopril, tramadol, hydrochlorothiazide, atorvastatin, doxycycline, vitamin D3, vitamin C, zinc

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

65+ years

Jan., 2021

none

Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

SPEECH DISORDER

60-64 years

Jan., 2021

No current illness for this event.

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

SUDDEN HEARING LOSS

18-29 years

Jan., 2021

None (Not an illness, but was on Keto diet over a month ago)

Vitamin C

30-39 years

Dec., 2020

Sudden hearing loss right ear accompanied by tinnitus

No current illness for this event.

Levothyroxine

Sudden hearing loss right arm accompanied by tinnitus

No current illness for this event.

Levothyroxin

65+ years

Jan., 2021

None

Eplerenone, Metoprolol, Digestive Advantage Lactose Defense, D3,B12, Biotin, Potassium

SUDDEN VISUAL LOSS

65+ years

Jan., 2021

Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment.

None

SURGERY

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

SYNCOPE

18-29 years

Jan., 2021

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

65+ years

Jan., 2021

Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.

None

TACHYCARDIA

18-29 years

Sep., 2020

No current illness for this event.

Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.

40-49 years

Dec., 2020

20 minutes post injection- generalized redness of skin, felt hot and flushed. 25 minutes - tachycardia heart rate. Went from 60?s to 120?s. 30 minutes- difficulty swallowing and hypoxia @ 90

None

NP Thyroid 90mg daily vitamin D3 10,000 daily Vitamin C 2000 daily Progesterone 100mg HS

TENDERNESS

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

TENDON DISORDER

18-29 years

Dec., 2020

None

Wellbutrin

THROMBECTOMY

30-39 years

Jan., 2021

None known

desogestreL-ethinyl estradioL (Enskyce) 0.15-0.03 mg per tablet, escitalopram (LEXAPRO) 20 MG tablet, spironolactone (ALDACTONE) 100 MG tablet

THROMBOLYSIS

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

THROMBOSIS

65+ years

Dec., 2020

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

None

Jan., 2021

None

No other medications for this event.

THROMBOTIC STROKE

50-59 years

Dec., 2020

PMH- Lupus; HTN; marked hyperlipidemia

Plaquenil Fioricet Midrin

TINNITUS

18-29 years

Jan., 2021

None (Not an illness, but was on Keto diet over a month ago)

Vitamin C

30-39 years

Dec., 2020

Sudden hearing loss right ear accompanied by tinnitus

No current illness for this event.

Levothyroxine

Sudden hearing loss right arm accompanied by tinnitus

No current illness for this event.

Levothyroxin

40-49 years

Dec., 2020

severe tinnitus and loss of hearing as some tones. persistent since day after vaccination and continuing through time of reporting to VAERS.

none

lisinopril 40mg, vitamin d3, cetirizine 10mg

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

65+ years

Jan., 2021

None

Eplerenone, Metoprolol, Digestive Advantage Lactose Defense, D3,B12, Biotin, Potassium

TREMOR

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

65+ years

Dec., 2020

COVID-19 positive

Eliquis, carbidopa-levidopa, Cardizem, Comtan, gabapentin, metoprolol, omeprazole, potassium citrate

ULTRASOUND DOPPLER ABNORMAL

40-49 years

Dec., 2020

Sinus infection at the beginning of December treated with augmentin

lexothyroxine, vitamin D, montelukast, manesium citrate

ULTRASOUND EYE

65+ years

Jan., 2021

None

No other medications for this event.

ULTRASOUND SCAN

50-59 years

Dec., 2020

Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.

none

URINARY TRACT INFECTION

65+ years

Jan., 2021

none

Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic)

URINE ANALYSIS

18-29 years

Jan., 2021

None

Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.

URTICARIA

30-39 years

Jan., 2021

None

Benadryl welbutrin

65+ years

Dec., 2020

none

Lysine, levothyroxine, B complex, Emergency C Estraidiol patch

VERTIGO

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

VISION BLURRED

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

VISUAL ACUITY REDUCED

65+ years

Jan., 2021

None

No other medications for this event.

VISUAL IMPAIRMENT

65+ years

Dec., 2020

high bp, high cholesterol,

Elequis, Amiodoron, pravastatin, losartin, synthroid, timalol

VITAMIN B12

50-59 years

Jan., 2021

Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,

COVID IN March 2020, resolved and had a second flare a week after symptoms improved.

Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN

VOMITING

30-39 years

Jan., 2021

None

Benadryl welbutrin

65+ years

Jan., 2021

WHITE BLOOD CELL COUNT INCREASED

60-64 years

Dec., 2020

None

Eliquis micardis. Metoprolol crestor asa

X-RAY

40-49 years

Jan., 2021

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

High blood pressure Migraines obesity asthma social distancing disorder

No other medications for this event.

60-64 years

Dec., 2020

None

X-RAY NORMAL

18-29 years

Jan., 2021

Covid with symptom onset of December 20th and ending December 28th

No other medications for this event.

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

ABDOMINAL DISCOMFORT

Unknown

Jan., 2021

Patient suffered cardiac arrest, though most likely result of illicit substance use; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; Patient suffered cardiac arrest, though most likely result of illicit substance use; This is a spontaneous report from a contactable physician. A 33-years-old male patient received bnt162b2 (BNT162B2, lot unknown), intramuscular on 14Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient suffered cardiac arrest 17Jan2021 11:15, though most likely result of illicit substance use since Jan2021, though patient had been feeling unwell with nausea and GI discomfort on 15Jan2021 23:15 after receiving the vaccine 36 hours prior to his arrest. The events were serious due to Life threatening illness (immediate risk of death from the event) and Disability or permanent damage. The patient had no COVID prior vaccination. COVID test type post vaccination=Nasal Swab on16Jan2021, test result was Negative. COVID test name post vaccination=Roche Cobas. The event outcome was not recovered. No treatment was received to events. No follow-up attempts are possible; information on lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events cardiac arrest, substance abuse, abdominal discomfort, malaise and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.

No current illness for this event.

No other medications for this event.

ABDOMINAL PAIN

30-39 years

Jan., 2021

1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdominal cramping for the rest of the day. I took some ibuprofen. The following morning (Wednesday), the pain was on my right abdomen and right flank area only. It was persistent, achy, soreness. My insides felt very tender to put any pressure on my right abdomen or flank. The pain on the right side of my back became more intense as the day went on. I had sharp right flank pain when lifting my right leg after showering to get dressing and use lotion. When I was walking up the stairs I turned to the left and had a sharp pain in the right flank again, taking my breath away for a moment. Around 4pm I took ibuprofen. About an hour later my eyes felt hot and tired. My cheeks were pink. My temp was 99.2. I generally just didn't feel good from this achiness. I took Benadryl and went to bed at 7pm, and slept for about 12 hours, waking once at midnight. The following day (Thursday) I felt 99% better and contacted my doctors office. When putting pressure on the same areas I could feel very slight tenderness if I pushed hard. That evening and into the next morning (Friday) I was mildly achy on my right side but barely at all. I didn't feel any more discomfort until this past week on the 22nd or 23rd. During sexual intercourse I felt that same mild internal tenderness on my right side. At this time, I don't believe I have any pain. My urine seems unusually clear, light colored, and smaller volume but this is very subjective. I have some abdominal swelling but this has been present since my breast reconstruction in January of 2020 and seems to get worse or better depending on the days activities or meals so it's hard to know what causes what. Labs were done on 1/22 showing decreased kidney fuction. Pending tests include an ultrasound of the Right Ovary that remains after the hysterectomy, bladder, and kidney. In addition to a 24 hour urine and some other urine studies.

some urinary difficulties and urinary tract infections since hysterectomy in 05/2020 which resulted in a bladder puncture that was repaired intra-op. Week prior to vaccine, UTI symptoms such as cloudy urine and urgency were present. Weekend prior to vaccine, hormonal symptoms were present such as PMS and hormonal acne.

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

Unknown

Unknown Date

Asthma attack within 60 minutes, dry throat immediately after vaccination, stuffy nose, short of breath, abdominal pain and diarrhea headache within 12 hours, temp of 101.3, chills, weakness and fatigue for 24 hours. GI symptoms stopped after 4 days. Wheezing, SOB, fatigue, headache continue until now (2 weeks post vaccine). I've been put on prednisone, multiple inhalers, and had a cortisone injection. The lower I get on the prednisone, the weaker and more fatigued I feel. I've missed work for 2 weeks now. Cannot fulfill my job duties with this weakness, fatigue, lightheaded and dizziness. I am on disability for now.

No current illness for this event.

No other medications for this event.

ABDOMINAL TENDERNESS

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

ABNORMAL SENSATION IN EYE

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

ACOUSTIC STIMULATION TESTS

50-59 years

Jan., 2021

I had a mild headache the evening of the shot, I had a headache the next two days that was relieved by Advil. I had a very sore arm at the injection site Friday and Saturday after the shot was given. The arm pain was gone Sunday morning. I was very tired on Saturday especially and slept through the morning and early afternoon on and off until about 3:00 pm. On Friday during the day, I noticed my right ear starting to feel unusual and uncomfortable. On Saturday, the ear issue continued, I felt like I had some hearing loss and a constant buzzing and ear fullness feeling. On Sunday, the ear issued continued with the hearing loss, buzzing and fullness and has through today and hasn't stopped. I tried some nasal decongestant on Sunday afternoon, but it didn't have any effect. I made an appointment with the ENT doctor on Monday morning for Tuesday. I had a hearing test on Tuesday and saw the ENT doctor on Wednesday. He prescribed prednisone and ordered an MRI. I will be starting the prednisone later today (Wednesday) when the pharmacy has the prescription ready.

none

Junel, pantoprazole, vitamin B-12, vitamin D, loratadine, fluoxetine

ACUTE MOTOR-SENSORY AXONAL NEUROPATHY

30-39 years

Jan., 2021

Acute sensory-motor neuropathy symptoms. Appears consistent with a mild Gullian Barre Syndrome

none

trazodone qhs prn

ACUTE MYOCARDIAL INFARCTION

40-49 years

Jan., 2021

Chest pains, trouble breathing . Diagnosis: Non ST segment elevation myocardial infarction

None

Tums, Pepcid AC

60-64 years

Jan., 2021

Pt admitted with a STEMI three days after vaccination with pzifer COVID-19 vaccine. Short time (<2hr) between symptoms onset and medical care. PCI on 1/14. Acute subtotal occlusion of proximal LAD and severe diffuse disease extending to distal LAD. Two DES to LAD (99% occluded) but RCA 50% and OMI1 60-65% also stenosed. Echo cardiogram 1/15. Pt noted to have severe wall motion abnormalities (severe hypokinesis of anterolateral and anteroseptal wall; akinesis of mid to distal anterior wall extending to the apex and distal inferior wall ) on echo. EF 30-35%. Received life vest on discharge.

None noted

Candesartan 4mg daily

AGEUSIA

30-39 years

Dec., 2020

Complete loss of smell and taste; Complete loss of smell and taste; This is a spontaneous report from a contactable physician reported for herself. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerbioNtech, lot number: EH9888) intramuscularly at left arm on 17Dec2020 at 03:00 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was reported as none. No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse event complete loss of smell and taste on 19Dec2020 at 07:00 AM. The event was considered as serious due to resulted in disability or permanent damage. No treatment received for the event. The outcome of event was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events complete loss of smell and taste cannot be totally excluded. 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.

No current illness for this event.

No other medications for this event.

40-49 years

Dec., 2020

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 17:30 in the left arm at single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient experienced soreness at injection site, cough, body aches on 19Dec2020; sore throat, voice changes from coughing on 20Dec2020; tested positive for covid on 21Dec2020; mild low congestion, loss of taste and smell on 22Dec2020. The nurse stated that he got the vaccine on Friday (18Dec2020). The next day (19Dec2020) he had common side effects: Soreness at the injection site and body aches, which were expected. He also had a cough on top of that, which progressed to the next day. His body aches and coughing were infrequent. The afternoon of Sunday (20Dec2020), he developed sore throat. Yesterday(21Dec2020), he said he could not work because he was still coughing and had a sore throat. His voice was also changing due to the coughing. He was getting better now. The doctor from Employee Heath said that the cough was concerning so he got a COVID swab test yesterday(21Dec2020), and today (22Dec2020) it came back positive. This morning (22Dec2020) he had loss of taste and smell. He no longer had sore throat or cough. He had the vaccine before the test. He wanted to know where they were at with information on this. Was this being monitored? How did this happen? Was it possible that the test was a false positive because he had the vaccine prior? He would like someone to give him an answer, if the test was a false positive due to the vaccine? His doctor could not tell if the test was legit a positive because of the vaccine. He was not able to work right now. He did not even know if the COVID was from the vaccine or not. Will he get compensation for this? Will his workplace cover his absences? In the case he went to the hospital, will this be considered a work related or vaccine related issue? The outcome of event soreness at injection site was recovered on 21Dec2020. The outcome of event tested positive for COVID was not recovered. The nurse considered the cough was disabling as this was not part of the symptoms to watch for after getting the vaccine. All of the symptoms currently besides the cough are not serious as of now, but it has put him out of work. The nurse considered all other events as non-serious except for cough (disabling). Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.

No current illness for this event.

No other medications for this event.

AMNESIA

30-39 years

Dec., 2020

Internal brain bleeding 10 days after 1st dose covid vaccine; Brain damage; confused; suffering memory loss; This is a spontaneous report from a contactable Physician (patient). This 39-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 18Dec2020 14:30 at single dose (lot number: EJ1685) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced internal brain bleeding and brain damage on 30Dec2020 07:30 after 1st dose covid vaccine. Brain surgery received on 29Dec2020. Events were still recovering. Patient was confused and suffering memory loss on 30Dec2020 07:30. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage. Days for hospitalization was 16. The patient received treatment for events as brain surgery due to internal brain bleeding. The patient was not pregnant. The patient had no COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was recovering.; Sender's Comments: The reported internal brain bleeding and brain damage with confused and memory loss more likely represented intercurrent disease, and less likely causally related to 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 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.

No current illness for this event.

No other medications for this event.

ANGIOGRAM

30-39 years

Jan., 2021

9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine

None

Multivitamin

ANGIOGRAM CEREBRAL

50-59 years

Dec., 2020

I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my balance. I developed very severe migraine headaches and was hospitalized. I still have not regained my balance. I have had a couple of courses of prednisone and migraine medication. My neurologist is setting up IV I G transfusions feeling that I?m having an auto immune response to the vaccine.

None

Metoprolol, hydrochlorothiazide, Wellbutrin, Celexa, Prilosec

65+ years

Jan., 2021

Patient came into the emergency department on 1/8/21 with an acute ischemic stroke with complete occlusion of her left MCA. She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at 10:31am.

Hypertension, hypothyroidism

No other medications for this event.

ANGIOPLASTY

40-49 years

Dec., 2020

I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not sure if these are related but I felt I should report it.

None

Propranolol, Pepcid,cetrizine, losartan

ANOSMIA

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

APHASIA

65+ years

Jan., 2021

Hypertension, hypothyroidism

No other medications for this event.

APTYALISM

40-49 years

Dec., 2020

Acute Bell's Palsy right side occurring on 1/16/2021, total right sides facial palsy involving eyelid, mouth, decreased salivary secretion, facial, ear, mastoid pain. Started prednisone 60mg daily and Acyclovir 400mg po 5x/day on 1/17/2020 x 1 week course. No improvement since onset.

No current illness for this event.

No other medications for this event.

AREFLEXIA

18-29 years

Dec., 2020

Pt describes falling with onset of weakness below the hip level about 6 inches above the patella with missing clonus reflex. The pt cannot squat down with associated observable loss of strength, pt is not able to stand up. The pt has fallen 7 times since symptom onset around lunchtime between 1200 and 1300. Pt denies LOC.

30-39 years

Dec., 2020

Patient presented to the emergency department with sensory loss and loss of reflexes, evaluated by neurology and diagnosed with Guillain- Barre Syndrome thought to be secondary to the Pfizer Covid Vaccine

n/a

ARTERIOGRAM CAROTID

65+ years

Jan., 2021

Hypertension, hypothyroidism

No other medications for this event.

ARTHRALGIA

18-29 years

Jan., 2021

On 01/07/2021 I woke up at 0300am with chills, headache, body aches, joint pain, fever of 101.2 and swollen left axillary lymph nodes. I took Tylenol and Benadryl and it relieved the fever/headache/body aches/joint pain, however the lymph nodes in my left axillary remained swollen. I continue to take Tylenol for the fever/body aches/pains without relief for the swollen and painful axillary lymph nodes. Warm compresses do help to relieve the pain temporarily but they remain painfully swollen. On 01/08/21 I called my doctors office to ask if it was normal to experience such painfully swollen axillary lymph nodes to which they stated ?we don?t know, it is too soon for us to tell what?s normal and what isn?t normal right now.? They did not offer any suggestions to relieve the pain or swelling. The morning of 01/09/2021 , I called Employee Health at my hospital (my place of work and also where I received the vaccine) and they also stated they didn?t know if this was a normal reaction due to the newness of the vaccine. A couple hours later, employee health emailed me a link to the VAERS reporting website and asked me to file a report.

No current illness for this event.

Vraylar 1.5mg daily Trintillix 40mg daily Vyvanse 60mg daily Vitamin C 1000mg daily

30-39 years

Dec., 2020

noticed twitching in L arm shortly after receiving vaccine, numbness , weakness and pain in arm and shoulder girdle, diagnosed with parsonage turner syndrome by neurologist, currently taking neurontin for pain as steroids not tolerated

No current illness for this event.

No other medications for this event.

When vaccine was administered, seemed high on my arm. I had immediate soreness and shoulder discomfort, I was told this was normal. It continued to progress and I eventually had decreased ROM, weakness and sharp shooting pain in my shoulder. Working at OI, I consulted provider, xrays were obtained and I was evaluated. He strongly suggested an MRI be obtained as well. That was completed the same day as my evaluation on 12/31/2020 (1 week and 2 days after the vaccine was administered). The provider informed me that they have had patients with similar situations that were evaluated for frozen shoulder after having a vaccine d/t administration site and vaccine going into subacromial space. He does report that this was my case/situation, upon my exam, I had severe inflammation with this as well-he is now having me follow up for a surgical consultation for my shoulder to be repaired. Today's date is 1/7/2021, I have these same ongoing symptoms that have continued since day of administration, without diminishing in severity. He is unable to provide an injection d/t my upcoming second dose of the COVID vaccine this next week, 1/12/2021. He strongly suggests that my 2nd vaccine be administered elsewhere-advised NOT be administered in the same shoulder OR in opposite to cause these symptoms to flare. He advised in gluteus if possible to avoid any further issues if at all possible.

No current illness for this event.

Novolog, Trokendi, Metoprolol, Biotin, Vitamin D, Vitamin C, Potassium

Jan., 2021

Right thumb joint pain. I can't hold unto things in my right hand that requires me using pressure from my thumb. Pain is a 9/10 when holding, grabbing, or using the thumb in any way. When not using the thumb there is no pain at all. I work out everyday and I am no longer to lift weights using my right hand because of the excruciating pain when I try to.

No current illness for this event.

No other medications for this event.

None

Multivitamin

Vaccine was administered very high, presumably in the joint space, rather than the deltoid. Patient experienced intense pain in the entire shoulder area for 24 hours following administration. After initial 24 hours, pain remained more localized in the joint itself. Pain is intensified when moving out of the neutral position.

None

Escitalopram, Tri-Lo-Marzia, Restasis, melatonin, Multivitamin, probiotic

40-49 years

Dec., 2020

Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also my left foot feels like pins and needles.

Had skin infection and took antibiotics 2 weeks prior

Metformin, Valsartan, Adderall, Asprin, Testosterone Enanthate, Anastrozole.

Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.

Environmental stress?

Lexapro, Wellbutrin, synthroid, elequis, ambien,acyclovir

Jan., 2021

1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be 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.

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the body, joint pain ( hands, wrist, feet, hips, knees, spine, neck), insomnia, general malaise, fatigue, and lower grade fever. Most symptoms lasted about 7 -10 days. However, it is now day 20 after the initial vaccine and I still have joint pain that has not gone away. esp in hands, wrists, and feet. When I sleep I still wake up with all my joints hurting it gets better as I start moving but the wrist, hands, and feet pain has not gone away. This pain will wake me in the night when I change positions. I called my doctor today to inquire if it is a good idea if I should take the second dose because the first dose made me so dibiliated. Awaiting for a response. I am due to take the second vaccine on 2/9/21.

none

Jan., 2021

involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.

No current illness for this event.

No other medications for this event.

60-64 years

Jan., 2021

Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. 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.

Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

No other medications for this event.

65+ years

Dec., 2020

Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.

None

Eliquis

Joint pain /felt like it was worsening joint pain; just severe pain to where she couldn't walk; This is a spontaneous report from a contactable Other HCP. A 70-year-old female patient received BNT162B2(Lot Number: ET1685), via an unspecified route of administration at Deltoid Left on 23Dec2020 08:00 at the 70 years old at single dose for COVID-19 immunization. The medical history included rheumatoid arthritis. The concomitant medications were none. The patient received the shot on 23Dec2020 and experienced Joint pain afterward on 02Jan2021. The patient did have rheumatoid arthritis so there was that. The patient felt like it was worsening joint pain on 02Jan2021. She has had no fever, just severe pain to where she couldn't walk on 02Jan2021. The joint pain has gotten worse and it has gotten to where she is going to advise her not to take the second shot. The Reporter assessed the seriousness for the events was Disabling. The events did not require a visit to Emergency Room but required a Physician Office visit on 06Jan2021. The patient received a steroid injection on 06Jan2021. There was none History of all previous immunization with the Pfizer vaccine considered as suspect. There was none Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no Prior Vaccinations within 4 weeks. The patient underwent lab tests and procedures, which included x-rays on 06Jan2021: unknown results (they were awaiting the X-rays). The outcome of the events was not recovered. The information on the batch number has been requested.; Sender's Comments: Based on the available information the events worsening joint pain and walking difficulty are attributed to underlying Rheumatoid arthritis; however, based on a compatible temporal association, contributory role of BNT162B2 vaccine to events occurrence 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.

No current illness for this event.

No other medications for this event.

ASPARTATE AMINOTRANSFERASE INCREASED

18-29 years

Dec., 2020

ASTHENIA

18-29 years

Dec., 2020

30-39 years

Jan., 2021

Pt experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 1/6/21 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Pt had televisit consult with psychiatry and neurology. She is subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. She is noted to have a history of shellfish allergy. She experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time.

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

Second vaccine 1/8/21: 10 hours post vaccine there was a 103 degree fever for 30 hours with sharp 9/10 muscle pain and partial awareness to time place and location. Fatigue and pain and nauseas and weakness continued up until day 5. At day 5 8pm: loss of sensation in feet and legs, unable to ambulate, day 6: hospitalized for 7 days. Currently in inpatient acute rehab to re learn how to walk. Sharp painful neuropathy ongoing.

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

40-49 years

Dec., 2020

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose, the patient developed severe pain around vaccination site and arm, followed by muscle atrophy, weakness and clinical signs consistent with acute brachial neuritis.

None

Jan., 2021

Parsonage Turner syndrome. 5 days after her second dose she developed severe pain ipsilateral to the injection site associated with weakness and muscle atrophy. Neurology exam consistent with acute brachial neuritis

None

50-59 years

Dec., 2020

none

GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY MD, XRAY ON LEFT SHOULDER DONE ON 1/6. ON 1/7, STIFFNESS WITH SEVERE PAIN UPON MOVEMENT NOTED ESP IN THE MORNING. ULTRASOUND WAS DONE ON 1/8, NOTED BICEPS TENOSYNOVITIS. ORTHOPEDIC SURGEON SEEN ON 1/11, W DX OF ADHESIVE CAPSULITIS, SUGGESTED FOR PT FOR NOW, AND OFF WORK, AND TO BE FOLLOWED UP ON 2/1 BY SAME ORTHO SURGEON. WILL NOT OFFER CORTISONE SHOT FOR NOW AS IT MAY COMPROMISED OR WEAKEN IMMUNE RESPONSE, IN WHICH MY SECOND COVID SHOT DUE ON THE 15TH OF JANUARY. FIRST APPT FOR PT ON 1/15

NONE

FIRST COVID SHOT GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY M

Jan., 2021

No current illness for this event.

No other medications for this event.

60-64 years

Jan., 2021

Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

No other medications for this event.

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

ASTHENOPIA

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

ASTHMA

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

ATAXIA

65+ years

Jan., 2021

Received Pfizer vaccine, first dose on Wed. 01/13/21 between 12 and 1 P.M. Thurs. 01/14/21 in the afternoon he began to note that he had difficultly walking. Went to bed when he woke up at 5:48 A.M. he reported he had ataxia. Patient reported having to walk in tiny steps to stay upright. He went to the emergency room. Had CT scan of head and found blood clots. MRI performed. Stroke found in right PCA territory, but no loss in strength in left lower extremity. Sensation and vision intact. Strength in all four extremities is 5 out of 5.

Baby Aspirin, Advil PM , vitamin D, atorvastatin 20 mg

AUDIOGRAM

30-39 years

Jan., 2021

Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score. Patient was started on high dose steroids with partial recovery of symptoms.

None

AUDIOGRAM ABNORMAL

50-59 years

Dec., 2020

12/18 VACCINATION 12/19 WOKE UP, RINGING IN BOTH EARS. CALLED PCP, CONSULTED ENT ABNORMALITY - L INNER EAR; HIGH DOSE STEROIDS, 10 DAYS, 60 MG/DAY. WEEK 2; TINNITUS GOT WORSE. DR. PRIMARY CARE PHYSICIAN MEDICAL EXAM ON 1/6/2021 INJECTION OF STEROIDS.

N/A

AXILLARY PAIN

50-59 years

Dec., 2020

none

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

60-64 years

Jan., 2021

Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10

None

Zoloft 12.5 mg daily

BACK PAIN

18-29 years

Dec., 2020

At about 6am after receiving the shot I felt very tender at the injection site almost as if it was bruised. Then over the course of the day I started to feel very itchy all over my body but mainly on my right side. 10pm I got up for work, and could barely move, I'm feeling intense back pain on my lower back on the right side. I can walk but its all very limited motion, I can really only manage by putting all my weight on my left side.

None

30-39 years

Dec., 2020

severe stabbing-shooting lower back pain; severe stabbing-shooting lower back pain that radiated to both legs; Pricking, pins and needles sensations in the hands and feet; numbness; weakness to both legs but mostly the right leg; Coordination problems, unsteadiness; Coordination problems, unsteadiness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 20Dec2020 08:00 at single dose at left arm for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks included multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies to medications, food, or other products. On 22Dec2020 at approximately 19:15, the patient experienced sudden onset of severe stabbing-shooting lower back pain that radiated to both legs. Pricking, pins and needles sensations in the hands and feet. Coordination problems, unsteadiness, numbness, and weakness to both legs but mostly the right leg. The patient underwent lab tests and procedures post-vaccination which included nasal swab for covid test: negative on 30Dec2020 (Antigen Test). Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Patient received pain medication, steroid dose pack, MRI (pending), and physical therapy (pending) as treatment. Outcome of all events was not recovered.; Sender's Comments: Based on the compatible temporal association, a contributory role of vaccination with BNT162B2 in the onset of the events cannot be 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.

No current illness for this event.

No other medications for this event.

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

40-49 years

Dec., 2020

Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also my left foot feels like pins and needles.

Had skin infection and took antibiotics 2 weeks prior

Metformin, Valsartan, Adderall, Asprin, Testosterone Enanthate, Anastrozole.

50-59 years

Jan., 2021

No current illness for this event.

No other medications for this event.

BALANCE DISORDER

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

None

Metoprolol, hydrochlorothiazide, Wellbutrin, Celexa, Prilosec

65+ years

Jan., 2021

Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.

None

Levothyroxine sod.75mcg 1 daily; Pravastin sod. 20mg 1 daily, Vit. D 50 mcg daily

BASAL GANGLIA HAEMORRHAGE

50-59 years

Dec., 2020

He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. 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.

No current illness for this event.

No other medications for this event.

BLOOD CHLORIDE NORMAL

18-29 years

Dec., 2020

BLOOD CREATININE INCREASED

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

BLOOD CREATININE NORMAL

18-29 years

Dec., 2020

BLOOD GLUCOSE INCREASED

60-64 years

Dec., 2020

left side will blur; Left side of face was sagging/ water leaking out of mouth/Progressive weakness on left side of face/ Swelling on lower left mandible/ diagnosed with Bell's Palsy.; Eye tearing; This is a spontaneous report from a contactable nurse who reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK5780) in left arm on 26Dec2020 at 08:30 at single dose for covid-19 immunisation (worked in surgical ICU and was over 61 years old). Medical history included Pre-diabetic. Family history included: mother died; mother's side had colon cancer and grandparents and uncles had cardiovascular diseases.Concomitant medication included exenatide (BYDUREON), amlodipine besilate (NORVASC), omeprazole (PROTONIX), hydrochlorothiazide, lisinopril and pneumococcal vaccine on 08Dec2020 and tetanus vaccine on 08Dec2020. It was reported that on 31Dec2020 at 07:30, the patient had eye tearing and water leaking out of mouth, left side of face was sagging, swelling on lower left mandible (eye tearing was first, as reported); on 31Dec2020 he also experienced progressive weakness on left side of face; on 02Jan2021 the patient was diagnosed with Bell's Palsy. Then on an unknown date, left side will blur occurred. All events required emergency room visit and physician office visit. Diagnosis of Bell's Palsy and event eye tearing were serious per disability; left side will blur was non serious. Patient described the events as follows: on 31Dec2020 he was brushing teeth and noticed the water was going everywhere. Left side of face was sagging, noticed some swelling and thought it was from a bug bite. He wasn't sure if it was a stroke or not. In the morning of 01Jan2021 noticed it was progressively causing a problem. Days before noticed tearing of left eye (as reported). On 31Dec2020 before midnight, something felt wrong. He saw four cases on clinical trial with similar side effects (he clarified he had no patient information for the four patients mentioned with similar side effects from Pfizer Clinical trial. He saw this information from a article; stated four from Pfizer and Moderna). In the morning of 02Jan202, he went to Emergency Room (ER) and was diagnosed with Bells Palsy. He was given prednisone 20mg to take 3 times by mouth every day for 5 days, tetracycline 100mg, at 1 capsule by mouth twice a day for 10 days and methylprednisolone (SOLU MEDROL; Lot: 9945776;Exp: Nov2021) 4mg dose pack, started with 6 tablets first day. It was told by doctor it might cause tick problems. He was waiting for results. On 04Jan2021 went to family doctor and more blood work was taken. Because he was taking prednisone, noticed his sugar was up a little bit (date unspecified). It was prescribed Glitizide extended release, 2.5mg one tablet twice a day with breakfast. Patient was checking sugar every 6 hours. It was also prescribed Acyclovir 400mg one tablet orally five times per day for 10 days. 08Jan2021 is last day of prednisone 5 day dose and will follow up with methylprednisolone tablets. Patient had an appointment with a neurologist on 13Jan2021. Patient was still having symptoms. It was really hard for him. Not hard to swallow. Face was still drooping. Eyes were still tearing. Could not work with eyes tearing all of the time. Needed to be alert. When driving, had to focus on the right side because his left side will blur. He had to chew only on the right side because food will be left behind in between his cheeks and gums. If he drank through a straw, he had to cover the left side of his lips so he was able to suck out fluids. He thought symptoms were progressively getting worse, he didn't see much improvement. He clarified swelling was on lower part of mandible on left side. It was slightly bigger than right. When looking at face, the lines on his forehead on the left side were down. If he smiled he cannot raise his left eye brow, when before the COVID-19 vaccine he could. Noticed left side of nose was lower than the right. Cannot raise left side of lips. Outcome of the event Eyes tearing and Bell's Palsy was not recovered; outcome of the other event was unknown. Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Bell's palsy, Lacrimation increased and vision blurred due to temporal relationship. However, the Bell's palsy may likely possibly represent concurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.

No current illness for this event.

BYDUREON; NORVASC; PROTONIX [OMEPRAZOLE]; ;

BLOOD GLUCOSE NORMAL

18-29 years

Dec., 2020

BLOOD POTASSIUM DECREASED

18-29 years

Dec., 2020

BLOOD PRESSURE DECREASED

65+ years

Dec., 2020

Tested positive for COVID-19; CT showed increased infiltrates 10-15%; Dehydration/Dehydrated; Chills; Tested positive for COVID-19; Hypotensive; Achy; Severe achy cramps/Severe cramps all over body; This is a spontaneous report from a contactable nephrologist (patient himself). This 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 78-year-old. The patient was diabetic and hypertensive. Additional medical history included hyperlipidaemia. No relevant concomitant medications were provided. On 18Dec2020, the patient developed severe achy cramps/severe cramps all over body. On 19Dec2020, the patient developed achy. On 20Dec2020, the patient was dehydrated and hypotensive, he had also chills. On unknown date, blood pressure was down to 76/50. His symptoms for COVID were severe achy cramps, hypotension, and dehydration. On 20Dec2020, COVID-19 test was positive. On 21Dec2020, the patient was given monoclonal antibodies. A computerized tomogram (CT) of the lungs was performed on 21Dec2020 and it was ok. A week later (Dec2020), he had a repeat CT which showed increased infiltrates of 10 to 15%. He then started on dexamethasone, apixaban (ELIQUIS) and the rest of the things. He had a repeat CT on 05Jan2021 which showed resolution of the infiltrates; most of the lesions went gone. CT results had improved significantly. The patient underwent a second COVID test a week ago which was still positive. He had a third COVID on 06Jan2021, but results were not available yet. The patient queried if he can proceed with second dose planned on 07Jan2021 or if he should wait. The clinical outcome was recovered for the event 'severe achy cramps/severe cramps all over body' on 19Dec2020, for 'dehydration/dehydrated' on 20Dec2020, for 'chills' on unknown date in Dec2020, for 'achy' on 30Dec2020, for 'hypotensive' on 20Dec2020; the outcome of the event 'CT showed increased infiltrates 10-15%' was recovering; the outcome for 'Tested positive for COVID-19' was unknown. The reporter considered the events 'achy' and 'severe achy cramps/severe cramps all over body' serious because causing disability; the events 'tested positive for COVID-19', 'dehydration/dehydrated', 'chills' and 'hypotensive' were considered medically significant. The reporter considered the events 'Tested positive for COVID-19', 'CT showed increased infiltrates 10-15%' and 'dehydrated/dehydration' unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. Case will be reassessed when new information is received. 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.

No current illness for this event.

No other medications for this event.

BLOOD PRESSURE INCREASED

30-39 years

Dec., 2020

"low grade fever; Her blood pressure was high/ still really high/ blood pressure was up; headache; Fifteen to twenty minutes after she received the vaccine she became light headed and dizzy/ light headedness and dizziness; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received BNT162B2 (Lot#: EK5730) via an unspecified route of administration on 17Dec2020 afternoon at single dose in the left arm for COVID-19 immunization. Caller was unable to confirm the manufacturer of the vaccine that she received. It is not written on the card, and she didn't see the vial. The patient medical history was not reported. Concomitant medications included oral contraception pill, but the name was unknown. Fifteen to twenty minutes after she received the vaccine on 17Dec2020 she became light headed and dizzy. She had to catch her breath. She couldn't shake it off. The light headedness and dizziness lasted at that intensity for 10 minutes, but it never went away. They encouraged her to be admitted in the emergency room (ER). She would say that the seriousness of being light headed and dizzy was disabling. Caller didn't remember the exact numbers for her blood pressure. It was 160's over 105. Her heart rate was in the low 100's, around 105. She stayed at the first monitoring station in the vaccine area for 2 hours. They were taking her blood pressure every five minutes. She was given diphenhydramine hydrochloride (BENADRYL) there and lots of water. After 3 hours and she was not improving they called a ""code medic"" that got the medical director and nursing supervisor to come. They encouraged her to go to the ER for continual monitoring. She stayed in the ER for4 hours and was given meds to help with the blood pressure. She was discharged from the ER home. She was nervous because of all this stemming from the vaccine. She had a low grade fever on 18Dec2020 (Friday) night. Caller stated her work had already reported her reaction. Occupational safety and the medical director are aware. Caller does not have reference number to provide. On 18Dec2020 (Friday) she was not overly concerned because it was the next day. Her blood pressure was high and her heart rate was in the 100's. They monitored her for a couple of hours and she was given a diphenhydramine hydrochloride (BENADRYL). She went to the emergency room (ER) for a few more hours and received additional treatment. They sent her home to be monitored at home. She has been taking her blood pressure every day since and it had not come down. It was still really high. She called her primary care doctor. He was wanting her to start blood pressure for medication it. She was concerned about starting it with the assumption that it was related to the vaccine. She would like to know the right thing to do. It seems safe to take the medicine, but it was unknown that whether it was going to mask the blood pressure and something else be going on. On 18Dec2020 she still had a headache and didn't feel well, but she thought she needed to give it some time. She had been anticipating not to feel well on 18Dec2020 (Friday). On 19Dec2020 she felt better considering she didn't have a headache. On 19Dec2020 (Saturday) her blood pressure was 138/90 and she felt good. Then on 20Dec2020 she had the bad headache and her blood pressure was up. On 20Dec2020 (Sunday) she had a bad headache and her blood pressure was 156/100. She came to work today and her blood pressure had been high all day. She still had a headache and the light headedness continued. The outcome of the event low grade fever was unknown, of other remain events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the event dizziness cannot be excluded based on a compatible temporal relation. 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."

No current illness for this event.

No other medications for this event.

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

65+ years

Jan., 2021

Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.

None

Levothyroxine sod.75mcg 1 daily; Pravastin sod. 20mg 1 daily, Vit. D 50 mcg daily

BLOOD SODIUM NORMAL

18-29 years

Dec., 2020

BLOOD TEST

40-49 years

Dec., 2020

One week after administration, I had sudden onset inability to move left arm. I was transported to ER immediately. Treated, scanned with CT of brain, MRI of brain, c-spine and brachioplexus. In hospital for 2 days and no answers. Still no answers to left arm paresthesia and proprioreceptor deficits. Spreading into left leg and mild systemic symptoms. I have been to the ER, seen by primary physician, Physiatrist and Neurology and Occupational Therapy. I am scheduled for many more appointments and trying to find and answer.

R/O Covid infection, COVID test was negative December 4, 2020. Primary Care MD diagnosed me with COVID after symptoms consistent with the virus on December 14, 2020.

Synthroid 6 am

Jan., 2021

After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure

None

50-59 years

Jan., 2021

14th of jan i had a pain around my jaw got up the next day i started having water eyes, the right side of face started to droop. went to ER and was diagnosed with Belspaulsy. after that did a follow up appointment with neurology

No current illness for this event.

metformin 100 mg, Lipitor

60-64 years

Dec., 2020

No current illness for this event.

BYDUREON; NORVASC; PROTONIX [OMEPRAZOLE]; ;

65+ years

Dec., 2020

Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.

None

Eliquis

BLOOD TEST NORMAL

30-39 years

Dec., 2020

Peripheral neuropathy

None

MVI, Vit D, Vit C, quercentin, NAC

On Thursday 1/21/2021, around 10am: I felt my left lip and mouth had a numbing taste and effect, I was slowly throughout the day unable to drink out of a cup without dribbling, my right eye was constantly watering, around 4pm: my right arm started tingling and bothering me, around 9pm: I tasted a Novocain(numbing) like taste in my mouth, I showered and went to bed, while in bed around 10:30pm: I drank out of a water cup and immediately drooled water onto my shirt and my right arm was starting to tingle even more, I thought that was out of the ordinary and got up to look in the mirror, when I looked in the mirror, my first thought was to smile and the right side of my mouth drooped, my right eye was drooping and I was unable to smile or close my eye. At 12:30: I went to the ER for tingling on my face and right arm, I thought I was having a stroke. In between home and traveling to the ER, paralysis started on my right side of face

no other illnesses at this time

none

BLOOD THYROID STIMULATING HORMONE NORMAL

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

40-49 years

Jan., 2021

Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11

None

Viorele, Fish Oil, Vitamin D, Prenatal vitamins

BLOOD UREA DECREASED

18-29 years

Dec., 2020

BODY TEMPERATURE ABNORMAL

40-49 years

Dec., 2020

Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.

Environmental stress?

Lexapro, Wellbutrin, synthroid, elequis, ambien,acyclovir

BODY TEMPERATURE INCREASED

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

BRACHIAL PLEXUS INJURY

30-39 years

Dec., 2020

numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. 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.

Birth control

No other medications for this event.

BRAIN INJURY

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

BRAIN OEDEMA

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

BRAIN OPERATION

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

thrombocytopenia; Stroke; bleed in the brain; This is a spontaneous report from a contactable physician (patient's sibling). A 39-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EJ1685), via an unspecified route of administration in the left arm deltoid on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The reporter is calling about the COVID Vaccine. She is calling on behalf of her sister (patient). The patient had her first dose on 18Dec2020, then she had thrombocytopenia (reported to be life threatening) causing her to bleed in the brain which led to a stroke (reported to be disabling). The reporter stated that she is a doctor herself, as well as her sister who experienced the stroke is a doctor also. The thrombocytopenia was diagnosed on 30Dec2020, which is the same day she had the stroke on 30Dec2020. They did the Tensilon Test when she was admitted to the emergency room on 30Dec2020. When admitted her platelets were Low, it was 36, that is dangerously low. They did a CT scan and found a large massive amount of blood clot. When queried if this is an infarct or hemorrhage, the reporter stated that this was an internal bleed for the stroke. She's in the hospital and had brain surgery. The thrombocytopenia at the moment was gone now. They gave her 6 units of blood and 4-5 units of platelets. The thrombocytopenia ended about 7 days after the diagnosis. Her sister is still in the hospital at this moment but in the Neuro Rehab unit. She is now confused after the stroke. Her sister has had no positive tests for Covid prior to the vaccine and no Antibody Test prior to the vaccine. Her sister has had no issues with vaccines in the past. Her sister had no vaccines on the same as the covid vaccine. At the end of the call, the reporter stated that because this was an injury caused by the vaccine, she is looking for compensation. The outcome of the event thrombocytopenia was recovered with sequel on 06Jan2021; for the event stroke was recovered with sequel on 30Dec2020; while for bleed in the brain was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events thrombocytopenia, bleed in the brain and stroke. Additional information regarding relevant medical history, underlying conditions and concomitant medications 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.

No current illness for this event.

No other medications for this event.

BREAST PAIN

60-64 years

Jan., 2021

None

Zoloft 12.5 mg daily

BREAST SWELLING

60-64 years

Jan., 2021

None

Zoloft 12.5 mg daily

BURNING SENSATION

65+ years

Jan., 2021

Noticed small area of burning sensation at right side of wrist and the vein there was very enlarged and sticking out.

No current illness for this event.

No other medications for this event.

BURSITIS

30-39 years

Jan., 2021

Immediate pain and loss of range of movement of left shoulder. Physical examination today demonstrates a healing injection site which is fairly superior on the left shoulder, and abduction of the left shoulder which is limited secondary to pain. Patient's physician's impression is that he has a subdeltoid bursitis which was temporally associated to the COVID-19 vaccination. (SIRVA)

No acute illness

None

40-49 years

Jan., 2021

Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am. The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications. She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa. The employee informed employee health director on 1/20/2021 and evaluated on same day. On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.

CARBON DIOXIDE NORMAL

18-29 years

Dec., 2020

CARDIAC ARREST

Unknown

Jan., 2021

No current illness for this event.

No other medications for this event.

CEREBRAL ARTERY OCCLUSION

65+ years

Jan., 2021

Hypertension, hypothyroidism

No other medications for this event.

CEREBRAL HAEMORRHAGE

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

No current illness for this event.

No other medications for this event.

65+ years

Jan., 2021

~2 weeks after 1st dose, patient suffered cerebral hemorrhage. Was also on Eliquis. Received KCentra.

No current illness for this event.

Gabapentin, tamulosin, atorvastatin, isosorbide, KCl, shingrix (4/23/20), twinrx (4/23/20), synthroid, omeprazole, eliquis

CEREBRAL INFARCTION

65+ years

Jan., 2021

Baby Aspirin, Advil PM , vitamin D, atorvastatin 20 mg

CEREBROVASCULAR ACCIDENT

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

65+ years

Jan., 2020

He had a stroke later that night after receiving vaccine.

No other medications for this event.

CHEST DISCOMFORT

40-49 years

Dec., 2020

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

65+ years

Dec., 2020

Chest pressure, dizziness, increased troponin lab value.

No current illness for this event.

No other medications for this event.

CHEST PAIN

40-49 years

Dec., 2020

Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.

Environmental stress?

Lexapro, Wellbutrin, synthroid, elequis, ambien,acyclovir

Jan., 2021

Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.

none known.

melatonin 3mg daily, magnesium 500mg daily, gabapentin 300mg BID

Chest pains, trouble breathing . Diagnosis: Non ST segment elevation myocardial infarction

None

Tums, Pepcid AC

50-59 years

Jan., 2021

No current illness for this event.

No other medications for this event.

CHEST X-RAY

65+ years

Dec., 2020

Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.

None

Eliquis

CHEST X-RAY ABNORMAL

40-49 years

Jan., 2021

none known.

melatonin 3mg daily, magnesium 500mg daily, gabapentin 300mg BID

CHEST X-RAY NORMAL

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

CHILLS

18-29 years

Jan., 2021

No current illness for this event.

Vraylar 1.5mg daily Trintillix 40mg daily Vyvanse 60mg daily Vitamin C 1000mg daily

40-49 years

Dec., 2020

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

50-59 years

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

No current illness for this event.

No other medications for this event.

60-64 years

Dec., 2020

blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.

No current illness for this event.

No other medications for this event.

Jan., 2021

Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. 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.

No current illness for this event.

No other medications for this event.

Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

No other medications for this event.

65+ years

Dec., 2020

Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.

None

Eliquis

on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amount swelling R hand --I iced and took acetaminophen. By Dec 25, hand very swollen and painful with decreased ROM all fingers

had surgery R hand for advanced arthritis 11/16/20 - arthrodesis R thumb. was recuperating

phenobarbital 60mg HS hydroxychloroquin 400mg HS famotidine 20mg HS occas acetaminophen or ibu

No current illness for this event.

No other medications for this event.

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

CLUMSINESS

30-39 years

Dec., 2020

12/21 had covid vaccine (dose 1). On evening of 12/29 had sudden onset of mild neck pain and significant weakness and numbness of left arm, weak hand grip, clumsiness in hand . Did not improve after trying to shake arm/move around , and took prednisone 40mg oral. Went to ER and had CT Cspine which did not show evidence of cervical pathology. Continued with corticosteroids, sought consultation with PMR and neurology specialists, and steroid dose increased to 60mg/day. Some improvement in strength , but still have diminished sensation and strength in left hand/arm. Unable to perform full job tasks as I am left hand dominant. Likely brachial neuritis / parsonage turner syndrome per both specialists seen. Continuing with corticosteroids at this time, pending bloodwork and OT evaluation

None

Balziva ( birth control )

COAGULATION TEST NORMAL

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

COLD SWEAT

40-49 years

Dec., 2020

Received COVID-19 vaccine on 12/18/2020 around 1225pm, ten minutes later while being monitored I started to feel hot flash, got dizzy like about to pass out, I asked to let me lay down, I felt the medication bitter taste in the back of my throat, I was clammy pale, I lay on a stretcher and put my feet up elevated, rapid response was called and BP was checked and Spo2, my hands were getting cold and tingling I was talking to RN, another RN, after laying down for ten minutes I sit up I was getting my BP back to normal, I sat down in the chair again for another 10 minutes, I was offered to go to the ER but I decline, I said I was getting better, after 15 minutes I left monitored by my supervisor I felt the medication in my stomach, after the tingling my fingers were numbed for the next days until present.

none

multivitamines

COMMINUTED FRACTURE

65+ years

Dec., 2020

Patient is a pleasant 83 y.o. female pediatrician with history of Sjogren's, hypothyroidism, hyperlipidemia, hypertension who had been at Hospital to get her Covid vaccine. 30 minutes after doing so she reports being in the lobby and about to walk upstairs and feeling fine. The next thing she knows she wakes up on the stairs with her nose and face bleeding surrounded by healthcare team. She denies any precipitating symptoms such as chest pain, shortness of breath, fevers dizziness, headache. She reports feeling well otherwise in the last few days. I did a thorough bony palpation exam including spine and he only point of tenderness besides on her face was the area above her right ankle. She does not have a history of syncope or collapse

None

amLODIPine, 7.5 mg, oral, Nightly ? cevimeline, 30 mg, oral, TID ? cholecalciferol (vitamin D3), 2,000 Units, oral, Daily ? irbesartan-hydrochlorothiazide, 1 tablet, oral, QAM ? levothyroxine, 50 mcg, oral, Daily at 0600 ? metoprolol s

COMPLEX REGIONAL PAIN SYNDROME

65+ years

Dec., 2020

had surgery R hand for advanced arthritis 11/16/20 - arthrodesis R thumb. was recuperating

phenobarbital 60mg HS hydroxychloroquin 400mg HS famotidine 20mg HS occas acetaminophen or ibu

COMPUTERISED TOMOGRAM

50-59 years

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

No current illness for this event.

metformin 100 mg, Lipitor

COMPUTERISED TOMOGRAM HEAD

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

None

Multivitamin

40-49 years

Dec., 2020

R/O Covid infection, COVID test was negative December 4, 2020. Primary Care MD diagnosed me with COVID after symptoms consistent with the virus on December 14, 2020.

Synthroid 6 am

"suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events "" lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm"" 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."

No current illness for this event.

SYNTHROID

50-59 years

Dec., 2020

None

Metoprolol, hydrochlorothiazide, Wellbutrin, Celexa, Prilosec

65+ years

Jan., 2021

Hypertension, hypothyroidism

No other medications for this event.

COMPUTERISED TOMOGRAM HEAD ABNORMAL

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

65+ years

Jan., 2021

Baby Aspirin, Advil PM , vitamin D, atorvastatin 20 mg

COMPUTERISED TOMOGRAM HEAD NORMAL

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

COMPUTERISED TOMOGRAM NECK

30-39 years

Dec., 2020

Birth control

No other medications for this event.

65+ years

Jan., 2021

Baby Aspirin, Advil PM , vitamin D, atorvastatin 20 mg

COMPUTERISED TOMOGRAM NORMAL

30-39 years

Dec., 2020

no other illnesses at this time

none

COMPUTERISED TOMOGRAM SPINE

30-39 years

Dec., 2020

None

Balziva ( birth control )

40-49 years

Dec., 2020

No current illness for this event.

SYNTHROID

COMPUTERISED TOMOGRAM THORAX ABNORMAL

65+ years

Dec., 2020

No current illness for this event.

No other medications for this event.

CONDITION AGGRAVATED

40-49 years

Jan., 2021

Worsened tinnitus. I had tinnitus that had largely resolved and since the vaccine, it's been extremely loud - more loud than ever before. I don't have any other lifestyle issues that would've aggravated the tinnitus.

none

Multivitamin

50-59 years

Jan., 2021

Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Fatigue; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on right deltoid on 05Jan2021 07:45 at single dose for covid-19 immunization. Family history included migraine (other family members). Medical history included mild blood pressure and kidney stones, reactive airway disease. Concomitant medication included colecalciferol (VITAMIN D), potassium, allopurinol and hydrochlorothiazide/valsartan for mild blood pressure and kidney stones, fluticasone propionate, salmeterol xinafoate (ADVAIR) for reactive airway disease, atorvastatin, and multivitamins. The patient previously took fluticasone propionate, salmeterol xinafoate (ADVAIR) and experienced dry mouth and lost sense of taste. The patient also previously took Tdap booster on Aug2020, Shingrix on 10Aug2020, and influenza on 12Oct2020; all for immunization; and tetanus injections for immunization and experienced localized tenderness. The patient had the first dose of BNT162B2 (lot number: EH9899) for COVID-19 immunization on 15Dec2020 and experienced localized tenderness at injection point. The received his second dose of COVID vaccine on 05Jan2021. With the first dose he had increased localized tenderness at injection site on 15Dec2020, and he rated it mild to moderate. He would say it was 80% resolved in 24 hours. It had completely resolved in 36 hours. He would say that he has recovered completely form the localized tenderness with the first dose. Then he noted his second dose was yesterday, in the context of not having much sleep the night before. The actual injection was uncommonly eerily painless. The other folks in his department had similar experience. Maybe it was the nurse who gave the injection. Maybe it was because it was the same area and sensitivity was decreased. They had to check the Band-Aid to make sure blood was there. The administration was painless. He was relieved when the arm started getting sore to know he actually received it. He had increased arm tenderness at injection site which he rated as moderate which has now resolved. It got to moderate where lifting the arm up was sore. He definitely knew that he had been vaccinated. He got the vaccine at 7:45AM and now it is 16 to 17 hours later and he would say the pain is mild now. It did persist. The first vaccine hurt a little more. He expects this to go away. Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias. He had unrelenting headache over night that was moderate to severe. He said it kept him awake. It was exacerbated by lying down. Sitting up helped him. It became a migraine which is something he doesn't often experience. Migraines are pretty rare for him. He took 800mg of Advil at 6AM that helped for headache and migraine. The weight of the patient was 250 to 255 pounds. Shaking, sweats, hot and cold flashes, and augmentation of myalgias have resolved. Everything has resolved except for a little headache. In the background he literally had one or two hours of sleep. He thinks that likely precipitated a migraine was increased. Last night he slept literally an hour. He took 800mg of Advil and fell asleep. He is operating on 2 hours of sleep in 48 hours. Most of the stuff is gone except a little headache and expected fatigue. Headache Seriousness Criteria: he would say that it was relatively disabling. He would not have been able to carry on. He wouldn't have been able to operate last night. It would have interfered. It was dissimilar to others. He gets rare migraines. Everything was amplified with a migraine. He certainly felt that. It was fair to say the vaccine precipitated the migraine that was mild or severe. He doesn't want to falsely attribute these things to the vaccine. Causality Headache: precipitated by the vaccine. In the context that he had not slept the night before. He had a nasopharyngeal COVID test and it was negative. He has been in a COVID study where they are looking at combination. They developed a saliva test at (Name). There is a combination of saliva oropharyngeal and immunoglobins. He has been negative multiple times. The outcome of the events headache and fatigue was not recovered and recovered for the rest of the events.; Sender's Comments: A causal association between BNT162B2 and the reported event headache cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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.

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

65+ years

Dec., 2020

No current illness for this event.

No other medications for this event.

CONFUSIONAL STATE

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

No current illness for this event.

No other medications for this event.

COORDINATION ABNORMAL

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

CORONARY ARTERIAL STENT INSERTION

60-64 years

Jan., 2021

None noted

Candesartan 4mg daily

CORONARY ARTERY OCCLUSION

40-49 years

Dec., 2020

I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not sure if these are related but I felt I should report it.

None

Propranolol, Pepcid,cetrizine, losartan

60-64 years

Jan., 2021

None noted

Candesartan 4mg daily

CORONARY ARTERY STENOSIS

60-64 years

Jan., 2021

None noted

Candesartan 4mg daily

COUGH

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

COVID-19

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

CSF CELL COUNT NORMAL

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

CSF CULTURE

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

CSF PROTEIN NORMAL

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

CULTURE NEGATIVE

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

DEAFNESS

30-39 years

Jan., 2021

None

50-59 years

Jan., 2021

none

Junel, pantoprazole, vitamin B-12, vitamin D, loratadine, fluoxetine

DEAFNESS NEUROSENSORY

30-39 years

Dec., 2020

Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; This is a spontaneous report from a contactable physician (patient). A 37-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 17:15 at single dose on her left arm for covid-19 immunization. Medical history included known allergies to penicillin. The patient had no other medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient was not received list of any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection on 23Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had received prednisone to treat the events. The outcome of the events was not recovered.; Sender's Comments: A possible contribution role of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of sensorineural hearing loss in left ear and headache cannot be excluded due to temporal relationship. 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.

No current illness for this event.

No other medications for this event.

60-64 years

Dec., 2020

left sudden sensorineural hearing loss , ear numbness. symptoms began 48 hours after vaccination. Treatment began 3 days after onset of symptoms and included high dose prednisone and trans-tympanic dexamethasone shots. The patient partially recovered after 3 weeks of treatment.

none

CoQ10, B12, fish oil

DECREASED APPETITE

60-64 years

Jan., 2021

No current illness for this event.

No other medications for this event.

DEFAECATION URGENCY

60-64 years

Jan., 2021

Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

No other medications for this event.

DEHYDRATION

65+ years

Dec., 2020

No current illness for this event.

No other medications for this event.

DIARRHOEA

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

DIFFERENTIAL WHITE BLOOD CELL COUNT ABNORMAL

18-29 years

Dec., 2020

DIFFERENTIAL WHITE BLOOD CELL COUNT NORMAL

40-49 years

Jan., 2021

Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11

None

Viorele, Fish Oil, Vitamin D, Prenatal vitamins

DIPLOPIA

40-49 years

Jan., 2021

None

DISABILITY

Unknown

Unknown Date

Several back operations of stimulator in the back and in pain management; This is a spontaneous report from a contactable Consumer. This adult female Consumer(patient) reported that: An adult female patient received bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation. Medical history was none. No known allergies. The patient's concomitant medications were not reported. Patient was not pregnant a time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior to vaccination. The patient experienced several back operations of stimulator in the back and in pain management on an unspecified date, resulted in disability or permanent damage. Post the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown. Information on the lot/batch number has been requested.

No current illness for this event.

No other medications for this event.

DISCOMFORT

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

DISORIENTATION

30-39 years

Jan., 2021

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

DIZZINESS

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

40-49 years

Dec., 2020

none

multivitamines

Jan., 2021

None

No current illness for this event.

No other medications for this event.

60-64 years

Dec., 2020

I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I have had these symptoms for 12 days, unchanged. I cannot work because of these symptoms. I have been to urgent care and have had lab work and an EKG

None

Multi vitamen

65+ years

Dec., 2020

Chest pressure, dizziness, increased troponin lab value.

No current illness for this event.

No other medications for this event.

Jan., 2021

Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.

None

Levothyroxine sod.75mcg 1 daily; Pravastin sod. 20mg 1 daily, Vit. D 50 mcg daily

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

DROOLING

30-39 years

Dec., 2020

no other illnesses at this time

none

60-64 years

Dec., 2020

No current illness for this event.

BYDUREON; NORVASC; PROTONIX [OMEPRAZOLE]; ;

DRUG SCREEN

18-29 years

Dec., 2020

DRY THROAT

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

DYSGEUSIA

40-49 years

Dec., 2020

none

multivitamines

DYSPHAGIA

40-49 years

Jan., 2021

None

DYSPHONIA

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

DYSPNOEA

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

40-49 years

Jan., 2021

None

Chest pains, trouble breathing . Diagnosis: Non ST segment elevation myocardial infarction

None

Tums, Pepcid AC

65+ years

Dec., 2020

Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.

None

Eliquis

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

DYSPNOEA EXERTIONAL

40-49 years

Dec., 2020

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

DYSSTASIA

18-29 years

Dec., 2020

40-49 years

Jan., 2021

None

EAR DISCOMFORT

50-59 years

Jan., 2021

none

Junel, pantoprazole, vitamin B-12, vitamin D, loratadine, fluoxetine

EAR PAIN

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

Jan., 2021

No current illness for this event.

No other medications for this event.

ECHOCARDIOGRAM ABNORMAL

60-64 years

Jan., 2021

None noted

Candesartan 4mg daily

ECHOCARDIOGRAM NORMAL

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

EJECTION FRACTION DECREASED

60-64 years

Jan., 2021

None noted

Candesartan 4mg daily

ELECTROCARDIOGRAM

30-39 years

Jan., 2021

None

Multivitamin

40-49 years

Jan., 2021

Chest pains, trouble breathing . Diagnosis: Non ST segment elevation myocardial infarction

None

Tums, Pepcid AC

50-59 years

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

65+ years

Dec., 2020

Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.

None

Eliquis

Jan., 2021

Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.

None

Levothyroxine sod.75mcg 1 daily; Pravastin sod. 20mg 1 daily, Vit. D 50 mcg daily

ELECTROCARDIOGRAM NORMAL

60-64 years

Dec., 2020

None

Multi vitamen

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

ELECTROCARDIOGRAM ST SEGMENT ELEVATION

40-49 years

Dec., 2020

I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not sure if these are related but I felt I should report it.

None

Propranolol, Pepcid,cetrizine, losartan

ELECTROMYOGRAM NORMAL

30-39 years

Dec., 2020

no other illnesses at this time

none

Jan., 2021

Acute sensory-motor neuropathy symptoms. Appears consistent with a mild Gullian Barre Syndrome

none

trazodone qhs prn

EPISTAXIS

65+ years

Dec., 2020

None

ERYTHEMA

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

Unknown

Dec., 2020

I received the Pfizer vaccine on 12/21/20 without adverse events other than soreness in deltoid. On 12/31/20 I began to notice pain, redness and swelling in second toe on R foot from base of toe to base of nail. I initially thought it was gout and self medicated with ibuprofen 400 mg BID x 1 day on 01/01/21 with some improvement. I did not take anything on 01/02/21 and woke up on 01/03/21 with return of swelling, redness and pain. I took another 400 mg of ibuprofen and it felt better but after examining the toe, I questioned whether I had developed pernio (COVID toe).

No current illness for this event.

ATORVASTATIN, EPLERENONE, EZETAMIBE, CITALOPRAM, JARDIANCE, ENTRESTO, XARELTO, CARVEDILOL, ASA, FOLATE

EXPOSURE DURING PREGNANCY

18-29 years

Jan., 2021

I was pregnant and my baby died two days after I took it and I got really sick

None

EYE PAIN

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

EYELID FUNCTION DISORDER

30-39 years

Dec., 2020

no other illnesses at this time

none

FACIAL ASYMMETRY

30-39 years

Jan., 2021

Following the first COVID vaccine dose on Dec/18/2020, I had headaches that started on the third day and ended on the tenth day. The headaches were usually light, unilateral, and alternating from one side to the other. I was usually functional except on the fourth and seventh days where the headaches were moderate to severe, and I took naps to help with the headaches for those two days. I have never had an issue with headaches before, and these symptoms were a new experience for me. I did not take any medications as treatment for the headaches. Following the second COVID vaccine dose on January/7/2021, I felt fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On January/10/2021, when I woke up that morning I again felt light, unilateral, and alternating headaches. In addition, I noticed that I was unable to move the left side of my face. I felt moderate tingling sensations associated with the distribution of the paralysis. When I looked in the mirror, I could quite noticeably see asymmetry in my face. I immediately went to the emergency department at the hospital where my primary care doctor is located. I was kept in the hospital into the next day for observation. After evaluation by a neurology team and an MRI, I was provided with the diagnosis of Bells Palsy. I have never previously been diagnosed with Bells Palsy, and I have never previously had a hospital stay before. The doctors prescribed medications which I am currently taking. As of today January/12/2021, the symptoms have had some improvement, but the symptoms still continue.

none

Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was provided with the diagnosis of Bells Palsy; I felt moderate tingling sensations associated with the distribution of the paralysis; Generalized muscle aches; I felt fatigue; Dizziness; This is a spontaneous report from a contactable Physician. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246) on 07Jan2021 at 09:00 a.m. intramuscular on left deltoid, at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 on 18Dec2020 at 09:00 on left arm (lot number: EK5730) and experienced headaches that started on the third day and ended on the tenth day. Following the second dose on 07Jan2021, patient experienced fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On 10Jan2021, he noticed that was unable to move the left side of his face. He felt moderate tingling sensations associated with the distribution of the paralysis. When looked in the mirror, he could quite noticeably see asymmetry in his face. Patient immediately visited emergency department at the hospital where his primary care doctor was located. Patient was kept in the hospital into the next day for observation (as reported). After evaluation by a neurology team and an MRI, patient was diagnosed with Bells Palsy. He had never previously been diagnosed with Bells Palsy, and never previously had a hospital stay before. It was also informed that patient underwent Nasal Swab for SARS-CoV-2 test on an unspecified date in Dec2020 and on 10Jan2021, both resulted negative. At the time of the reporting, the symptoms continued.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diagnosed Bells Palsy presented as unable to move the left side of his face/felt moderate tingling sensations associated with the distribution of the paralysis/asymmetry in his face cannot be excluded, considering the plausible temporal relationship. 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.

No current illness for this event.

OMEPRAZOLE

FACIAL BONES FRACTURE

65+ years

Dec., 2020

None

FACIAL PAIN

40-49 years

Dec., 2020

patient developed acute onset of right-sided facial palsy and pain; patient developed acute onset of right-sided facial palsy and pain; Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 18Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included psoriasis. No COVID prior vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.No known allergies. Concomitant medications (received within 2 weeks of vaccination) included fluoxetine. days following vaccination,on 23Dec2020,the patient developed acute onset of right-sided facial palsy and pain. Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation. Work-up is ongoing. AE Resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].It was unknown if the event was treated. The event was assessed as serious for Disabling/Incapacitating. The patient had been tested for COVID post vaccination (covid test result-Negative). The outcome of the events werenot recovered Information about lot/batch number has been requested.; Sender's Comments: A possible causal relationship between acute onset of right-sided facial palsy and pain with MRI findings suspicious for brain inflammation and BNT162B2 cannot be completely ruled out considering the temporal relationship. 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.

No current illness for this event.

No other medications for this event.

No current illness for this event.

No other medications for this event.

FACIAL PARALYSIS

30-39 years

Dec., 2020

no other illnesses at this time

none

Jan., 2021

none

No current illness for this event.

OMEPRAZOLE

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

No current illness for this event.

No other medications for this event.

50-59 years

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

No current illness for this event.

metformin 100 mg, Lipitor

60-64 years

Dec., 2020

Woke up 1/4/21 with right sided facial weakness consistent with Bell's Palsy. Started high dose Prednisone and Valtex. Received IVIG infusion on 1/6/21 and 1/7/21. Mild improvement 1/11/21.

None

No current illness for this event.

BYDUREON; NORVASC; PROTONIX [OMEPRAZOLE]; ;

65+ years

Jan., 2021

Bell?s palsy on left side (onset 01/24) T/t Valacylovir 1000 mg PO TID x 1 week and prednisone 60 mg PO Daily x 1 week.

No current illness for this event.

No other medications for this event.

Unknown

Jan., 2021

bell's palsy from covid vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on Jan2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Jan2021 the patient experienced bell's palsy from COVID-19 vaccine. The event resulted in doctor office/clinic visit, disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. At the time of reporting the outcome of the event was not recovered. Information on the lot/batch number has been requested.

No current illness for this event.

No other medications for this event.

FACIAL PARESIS

60-64 years

Dec., 2020

Woke up 1/4/21 with right sided facial weakness consistent with Bell's Palsy. Started high dose Prednisone and Valtex. Received IVIG infusion on 1/6/21 and 1/7/21. Mild improvement 1/11/21.

None

No current illness for this event.

BYDUREON; NORVASC; PROTONIX [OMEPRAZOLE]; ;

65+ years

Jan., 2021

Hypertension, hypothyroidism

No other medications for this event.

FALL

18-29 years

Dec., 2020

50-59 years

Dec., 2020

felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine. On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability. On 21Dec2020, the patient had itchiness in her head. The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability. The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020. The outcome of the events was not recovered. The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, stroke was not diagnosed. 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.

No current illness for this event.

No other medications for this event.

FATIGUE

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

none

None

Multivitamin

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

No current illness for this event.

OMEPRAZOLE

40-49 years

Dec., 2020

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.

Environmental stress?

Lexapro, Wellbutrin, synthroid, elequis, ambien,acyclovir

Jan., 2021

None

50-59 years

Dec., 2020

none

No current illness for this event.

No other medications for this event.

Jan., 2021

none

Junel, pantoprazole, vitamin B-12, vitamin D, loratadine, fluoxetine

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

60-64 years

Jan., 2021

No current illness for this event.

No other medications for this event.

Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

No other medications for this event.

65+ years

Dec., 2020

had surgery R hand for advanced arthritis 11/16/20 - arthrodesis R thumb. was recuperating

phenobarbital 60mg HS hydroxychloroquin 400mg HS famotidine 20mg HS occas acetaminophen or ibu

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

FEEDING DISORDER

40-49 years

Jan., 2021

None

FEELING ABNORMAL

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

40-49 years

Dec., 2020

none

multivitamines

50-59 years

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

No current illness for this event.

No other medications for this event.

60-64 years

Dec., 2020

No current illness for this event.

BYDUREON; NORVASC; PROTONIX [OMEPRAZOLE]; ;

FEELING COLD

30-39 years

Jan., 2021

None

Multivitamin

40-49 years

Jan., 2021

None

50-59 years

Jan., 2021

No current illness for this event.

No other medications for this event.

60-64 years

Jan., 2021

Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

No other medications for this event.

FEELING DRUNK

40-49 years

Jan., 2021

None

FEELING OF BODY TEMPERATURE CHANGE

50-59 years

Jan., 2021

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

FINE MOTOR SKILL DYSFUNCTION

30-39 years

Dec., 2020

Birth control

No other medications for this event.

FLANK PAIN

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

FLATULENCE

60-64 years

Jan., 2021

Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

No other medications for this event.

FLUSHING

30-39 years

Dec., 2020

Received my vaccine on December 22nd, 2020 at around 830 Am. That afternoon, about 3 PM, I started to have a reaction. It started with tingling/numbness in my right hand which progressed up my arm into my elbow. About 10 minutes later, it then progressed into my right foot, and my left foot. About 10 minutes after that, I started to get flushed and a neck rash (diagnosed from Dr.). I took Benadryl and Ibuprofen 800mg PO every 6 hours for the next 24 hours. The numbness in my right foot and left foot along with the flushness went away a couple hours later. Although, the numbness in my right hand never went away. It came and went for the next 4 days until December 27th and 28th when it started getting worse. On December 28th evening, it got so bad that I was debating going to the emergency room around 1 am. The numbness and tingling was in my right hand and started shooting up my arm. The nerve pain around my wrist was unbearable. I finally fell asleep and the next morning, it was not nearly as bad, but was still there. The numbness and tingling moved from my right hand mainly to right hand, right foot, right leg, left foot and left hand today (12-30-2020).

None

FOETAL DEATH

18-29 years

Jan., 2021

I was pregnant and my baby died two days after I took it and I got really sick

None

FULL BLOOD COUNT

30-39 years

Jan., 2021

None

Multivitamin

65+ years

Jan., 2021

Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.

None

Levothyroxine sod.75mcg 1 daily; Pravastin sod. 20mg 1 daily, Vit. D 50 mcg daily

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

FULL BLOOD COUNT ABNORMAL

18-29 years

Dec., 2020

FULL BLOOD COUNT NORMAL

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

40-49 years

Jan., 2021

Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11

None

Viorele, Fish Oil, Vitamin D, Prenatal vitamins

60-64 years

Dec., 2020

None

Multi vitamen

none

CoQ10, B12, fish oil

GAIT DISTURBANCE

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

65+ years

Jan., 2021

Baby Aspirin, Advil PM , vitamin D, atorvastatin 20 mg

GAIT INABILITY

30-39 years

Jan., 2021

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

65+ years

Dec., 2020

No current illness for this event.

No other medications for this event.

GASTROINTESTINAL DISORDER

60-64 years

Jan., 2021

Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

No other medications for this event.

GLOMERULAR FILTRATION RATE DECREASED

30-39 years

Jan., 2021

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

GLYCOSYLATED HAEMOGLOBIN NORMAL

40-49 years

Jan., 2021

Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11

None

Viorele, Fish Oil, Vitamin D, Prenatal vitamins

GRIP STRENGTH DECREASED

30-39 years

Dec., 2020

None

Balziva ( birth control )

Birth control

No other medications for this event.

GUILLAIN-BARRE SYNDROME

30-39 years

Dec., 2020

n/a

Jan., 2021

Acute sensory-motor neuropathy symptoms. Appears consistent with a mild Gullian Barre Syndrome

none

trazodone qhs prn

HAEMATOCRIT NORMAL

18-29 years

Dec., 2020

HAEMOGLOBIN NORMAL

18-29 years

Dec., 2020

HAEMOLYTIC ANAEMIA

Unknown

Jan., 2021

The patient had Hemolytic Anemia with symptoms starting within the first 24 hours of vaccine administration.; The first dose received on 18Dec2020 and the second dose received on 06Jan2021; The first dose received on 18Dec2020 and the second dose received on 06Jan2021; This is a spontaneous report from a contactable consumer. This consumer reported for a 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 06Jan2021. Relevant history and concomitant drugs were unknown. The patient previously received the first dose of BNT162B2 on 18Dec2020 for COVID-19 immunization. The patient did not receive other vaccine in four weeks of vaccination. No known allergies. The patient had Hemolytic Anemia with symptoms starting within the first 24 hours of vaccine administration on 06Jan2021. The patient had emergency room visit and physician office visit. No treatment was received (as reported). Outcome of event was unknown. The event was assessed as serious with serious criteria: Life-threatening, disability. Information about Batch/Lot number has been requested.

No current illness for this event.

No other medications for this event.

HAEMORRHAGE

65+ years

Dec., 2020

None

HEADACHE

18-29 years

Jan., 2021

No current illness for this event.

Vraylar 1.5mg daily Trintillix 40mg daily Vyvanse 60mg daily Vitamin C 1000mg daily

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

No current illness for this event.

No other medications for this event.

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

none

None

Multivitamin

No current illness for this event.

OMEPRAZOLE

40-49 years

Dec., 2020

Soreness and weakness of left arm for more than 5 days. Intermittent headaches and runny nose

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

none

Jan., 2021

none

Junel, pantoprazole, vitamin B-12, vitamin D, loratadine, fluoxetine

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

No current illness for this event.

No other medications for this event.

60-64 years

Dec., 2020

No current illness for this event.

No other medications for this event.

Jan., 2021

No current illness for this event.

No other medications for this event.

65+ years

Dec., 2020

had surgery R hand for advanced arthritis 11/16/20 - arthrodesis R thumb. was recuperating

phenobarbital 60mg HS hydroxychloroquin 400mg HS famotidine 20mg HS occas acetaminophen or ibu

Jan., 2021

Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.

None

Levothyroxine sod.75mcg 1 daily; Pravastin sod. 20mg 1 daily, Vit. D 50 mcg daily

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

HEART RATE INCREASED

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

65+ years

Jan., 2021

Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.

None

Levothyroxine sod.75mcg 1 daily; Pravastin sod. 20mg 1 daily, Vit. D 50 mcg daily

HEMIPARESIS

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

HOT FLUSH

40-49 years

Dec., 2020

none

multivitamines

HYPERAESTHESIA

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

HYPERHIDROSIS

40-49 years

Dec., 2020

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

50-59 years

Jan., 2021

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

HYPERSENSITIVITY

40-49 years

Dec., 2020

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

HYPERSOMNIA

40-49 years

Dec., 2020

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

HYPERTENSION

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

40-49 years

Jan., 2021

None

HYPOACUSIS

30-39 years

Jan., 2021

None

50-59 years

Dec., 2020

N/A

HYPOAESTHESIA

18-29 years

Dec., 2020

On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outside of my car for around 15 minutes during a temperature of about 50 degrees. I realized when sharp pain was felt at the digit. After about 5 minutes the digit felt numb. I got in my car, turned on the heater, and massaged my finger. Sharp pain was felt again as circulation returned to the digit. The event last approximately 10 minutes from the moment I realized the finger was pale until color returned. This occurred again on 12/27 at around 2 PM as I walked from my car into a store at a temperature of about 40 degrees. This time, discoloration occurred bilaterally on my left 3rd, 4th, and 5th digits and my right 2nd, 3rd, 4th, and 5th digits. The event lasted more than 15 minutes with constant massaging. This has occurred two more times since then, both times occurring bilaterally with minimal exposure to cold.

N/A

TriSplintec Oral Contraceptives

Jan., 2021

Pt's injection was given into the bony prominence at acromion process . Pt reported immediate entire arm went numb immediately with immediate pain. She went back home to Ohio and was seen on 1/10 given a Medrol dose pack and sling. Instructed to rest and Ice the area. Initially the pain seem to improve after steroids, After finishing steroids and returning to work pain and limited ROM has continued to increase. Reports pain at injection site that becomes sharp and worse with certain movements Her fingertips feel like pens & needles.

None

Pt given Medrol dose pack on 1/10/2021 as well as taking Naproxen. Pt given another dose of Medrol on 1/21/2021

30-39 years

Dec., 2020

None

No current illness for this event.

No other medications for this event.

None

Balziva ( birth control )

Birth control

No other medications for this event.

No current illness for this event.

No other medications for this event.

40-49 years

Dec., 2020

none

multivitamines

Jan., 2021

Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11

None

Viorele, Fish Oil, Vitamin D, Prenatal vitamins

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later started experiencing tingling, buzzing, weakness and heaviness to my right arm and leg. I reported this to my MS doctor who ordered an MRI of the brain and told me to report to you

No current illness for this event.

vitamin d3 multivitamin calcium fish oil cranberry ambien

60-64 years

Dec., 2020

none

CoQ10, B12, fish oil

HYPOAESTHESIA ORAL

30-39 years

Dec., 2020

no other illnesses at this time

none

HYPOREFLEXIA

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

HYPOTENSION

65+ years

Dec., 2020

No current illness for this event.

No other medications for this event.

HYPOTONIA

65+ years

Jan., 2021

Hypertension, hypothyroidism

No other medications for this event.

IMAGING PROCEDURE

40-49 years

Jan., 2021

IMMEDIATE POST-INJECTION REACTION

18-29 years

Jan., 2021

None

Pt given Medrol dose pack on 1/10/2021 as well as taking Naproxen. Pt given another dose of Medrol on 1/21/2021

30-39 years

Dec., 2020

No current illness for this event.

Novolog, Trokendi, Metoprolol, Biotin, Vitamin D, Vitamin C, Potassium

Jan., 2021

No acute illness

None

40-49 years

Jan., 2021

60-64 years

Dec., 2020

None

Multi vitamen

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

IMMUNE THROMBOCYTOPENIA

40-49 years

Jan., 2021

none known.

melatonin 3mg daily, magnesium 500mg daily, gabapentin 300mg BID

IMMUNOGLOBULIN THERAPY

40-49 years

Jan., 2021

none known.

melatonin 3mg daily, magnesium 500mg daily, gabapentin 300mg BID

60-64 years

Dec., 2020

Woke up 1/4/21 with right sided facial weakness consistent with Bell's Palsy. Started high dose Prednisone and Valtex. Received IVIG infusion on 1/6/21 and 1/7/21. Mild improvement 1/11/21.

None

IMPAIRED WORK ABILITY

30-39 years

Dec., 2020

None

Balziva ( birth control )

Birth control

No other medications for this event.

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

NONE

No current illness for this event.

No other medications for this event.

60-64 years

Dec., 2020

None

Multi vitamen

No current illness for this event.

BYDUREON; NORVASC; PROTONIX [OMEPRAZOLE]; ;

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

INFLAMMATION

30-39 years

Dec., 2020

No current illness for this event.

Novolog, Trokendi, Metoprolol, Biotin, Vitamin D, Vitamin C, Potassium

40-49 years

Dec., 2020

Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also my left foot feels like pins and needles.

Had skin infection and took antibiotics 2 weeks prior

Metformin, Valsartan, Adderall, Asprin, Testosterone Enanthate, Anastrozole.

INFLUENZA LIKE ILLNESS

30-39 years

Dec., 2020

Followed by neurological symptoms staring day 4; parasthesias of both upper extremity; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; Flu like symptoms first 3 days; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ek5730) at left arm, via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension, diabetes, migraines, Eosinophilic granulomatosis with polyangiitis (EGPA) remission. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 21Dec2020, the patient experienced flu like symptoms first 3 days. Followed by neurological symptoms staring day 4, parasthesias of both upper extremity with progression to muscle weakness of all four extremities. Leading to 2 ER visits and hospital admission. Evaluation by internal medicine, neurology and rheumatology. Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The treatment for events included High dose steroid. Covid test included Nasal Swab: negative on 19Dec2020. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events influenza like illness, neurological symptom, paraesthesia, muscular weakness and peroneal nerve palsy cannot be excluded. The information available in this report is limited. This case will be reassessed once 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.

No current illness for this event.

No other medications for this event.

60-64 years

Jan., 2021

No current illness for this event.

No other medications for this event.

INJECTED LIMB MOBILITY DECREASED

30-39 years

Jan., 2021

No acute illness

None

40-49 years

Jan., 2021

50-59 years

Dec., 2020

NONE

INJECTION SITE EXTRAVASATION

40-49 years

Jan., 2021

INJECTION SITE PAIN

18-29 years

Dec., 2020

None

Jan., 2021

None

Pt given Medrol dose pack on 1/10/2021 as well as taking Naproxen. Pt given another dose of Medrol on 1/21/2021

30-39 years

Jan., 2021

No acute illness

None

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

Jan., 2021

50-59 years

Dec., 2020

NONE

Jan., 2021

none

Junel, pantoprazole, vitamin B-12, vitamin D, loratadine, fluoxetine

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

INJECTION SITE REACTION

40-49 years

Jan., 2021

INJURY

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

INNER EAR DISORDER

50-59 years

Dec., 2020

N/A

INSOMNIA

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

none

INTRACRANIAL MASS

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

ISCHAEMIC STROKE

65+ years

Jan., 2021

Hypertension, hypothyroidism

No other medications for this event.

Baby Aspirin, Advil PM , vitamin D, atorvastatin 20 mg

JOINT RANGE OF MOTION DECREASED

18-29 years

Jan., 2021

None

Pt given Medrol dose pack on 1/10/2021 as well as taking Naproxen. Pt given another dose of Medrol on 1/21/2021

30-39 years

Dec., 2020

No current illness for this event.

Novolog, Trokendi, Metoprolol, Biotin, Vitamin D, Vitamin C, Potassium

65+ years

Dec., 2020

had surgery R hand for advanced arthritis 11/16/20 - arthrodesis R thumb. was recuperating

phenobarbital 60mg HS hydroxychloroquin 400mg HS famotidine 20mg HS occas acetaminophen or ibu

JOINT SWELLING

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

LABORATORY TEST

30-39 years

Dec., 2020

n/a

50-59 years

Dec., 2020

None

Metoprolol, hydrochlorothiazide, Wellbutrin, Celexa, Prilosec

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

LABORATORY TEST NORMAL

40-49 years

Jan., 2021

Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11

None

Viorele, Fish Oil, Vitamin D, Prenatal vitamins

60-64 years

Dec., 2020

none

CoQ10, B12, fish oil

LACRIMATION INCREASED

30-39 years

Dec., 2020

no other illnesses at this time

none

50-59 years

Jan., 2021

No current illness for this event.

metformin 100 mg, Lipitor

60-64 years

Dec., 2020

No current illness for this event.

BYDUREON; NORVASC; PROTONIX [OMEPRAZOLE]; ;

LETHARGY

30-39 years

Dec., 2020

I was diagnosed with COVID-19 on 12/7/2020. My course of symptoms lasted 16 days, meaning I started feeling healthy again on 12/23/20. I am a pharmacist with a healthcare system and they have been offering the Pfizer/Biontech COVID-19 vaccine for essential associates. I received by first dose of vaccine on 12/31/20. On 1/1/20 I woke up with very noticeable muscle aches and fairly profound lethargy, which last 18-20 hours. I was not able to do much on 1/1/21 because of the way I was feeling. I'm not sure if this reaction is normal for patients who receive their COVID-19 vaccine close to their illness/infection with COVID-19, which is why I'm reporting this to the FDA.

None

Famotidine 40 mg daily, TUMS 1-2 tablets daily prn, APAP 500 mg daily prn, Magnesium tablets 500 mg daily, Voltaren OTC gel apply to affected area daily prn

LEUKOCYTOSIS

18-29 years

Dec., 2020

LIMB DISCOMFORT

50-59 years

Dec., 2020

No current illness for this event.

vitamin d3 multivitamin calcium fish oil cranberry ambien

LIP SWELLING

50-59 years

Jan., 2021

No current illness for this event.

No other medications for this event.

LIVER FUNCTION TEST NORMAL

40-49 years

Jan., 2021

Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11

None

Viorele, Fish Oil, Vitamin D, Prenatal vitamins

LOSS OF CONSCIOUSNESS

65+ years

Dec., 2020

None

LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES

30-39 years

Jan., 2021

No current illness for this event.

No other medications for this event.

60-64 years

Jan., 2021

No current illness for this event.

No other medications for this event.

LOSS OF PROPRIOCEPTION

40-49 years

Dec., 2020

R/O Covid infection, COVID test was negative December 4, 2020. Primary Care MD diagnosed me with COVID after symptoms consistent with the virus on December 14, 2020.

Synthroid 6 am

No current illness for this event.

SYNTHROID

LOWER RESPIRATORY TRACT CONGESTION

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

LUMBAR PUNCTURE NORMAL

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

LUNG INFILTRATION

65+ years

Dec., 2020

No current illness for this event.

No other medications for this event.

LYMPH NODE PAIN

18-29 years

Jan., 2021

No current illness for this event.

Vraylar 1.5mg daily Trintillix 40mg daily Vyvanse 60mg daily Vitamin C 1000mg daily

60-64 years

Jan., 2021

None

Zoloft 12.5 mg daily

LYMPHADENOPATHY

18-29 years

Jan., 2021

No current illness for this event.

Vraylar 1.5mg daily Trintillix 40mg daily Vyvanse 60mg daily Vitamin C 1000mg daily

50-59 years

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

60-64 years

Jan., 2021

None

Zoloft 12.5 mg daily

MAGNETIC RESONANCE IMAGING

30-39 years

Dec., 2020

n/a

Peripheral neuropathy

None

MVI, Vit D, Vit C, quercentin, NAC

40-49 years

Dec., 2020

R/O Covid infection, COVID test was negative December 4, 2020. Primary Care MD diagnosed me with COVID after symptoms consistent with the virus on December 14, 2020.

Synthroid 6 am

No current illness for this event.

SYNTHROID

50-59 years

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

MAGNETIC RESONANCE IMAGING ABNORMAL

30-39 years

Jan., 2021

none

No current illness for this event.

OMEPRAZOLE

MAGNETIC RESONANCE IMAGING BRAIN

30-39 years

Jan., 2021

None

Multivitamin

40-49 years

Dec., 2020

R/O Covid infection, COVID test was negative December 4, 2020. Primary Care MD diagnosed me with COVID after symptoms consistent with the virus on December 14, 2020.

Synthroid 6 am

No current illness for this event.

SYNTHROID

50-59 years

Dec., 2020

No current illness for this event.

vitamin d3 multivitamin calcium fish oil cranberry ambien

None

Metoprolol, hydrochlorothiazide, Wellbutrin, Celexa, Prilosec

MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

65+ years

Jan., 2021

Baby Aspirin, Advil PM , vitamin D, atorvastatin 20 mg

MAGNETIC RESONANCE IMAGING BRAIN NORMAL

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

MAGNETIC RESONANCE IMAGING HEART

65+ years

Jan., 2021

Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.

None

Levothyroxine sod.75mcg 1 daily; Pravastin sod. 20mg 1 daily, Vit. D 50 mcg daily

MAGNETIC RESONANCE IMAGING JOINT

30-39 years

Dec., 2020

No current illness for this event.

Novolog, Trokendi, Metoprolol, Biotin, Vitamin D, Vitamin C, Potassium

MAGNETIC RESONANCE IMAGING NORMAL

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

60-64 years

Dec., 2020

none

CoQ10, B12, fish oil

MAGNETIC RESONANCE IMAGING SPINAL

40-49 years

Dec., 2020

R/O Covid infection, COVID test was negative December 4, 2020. Primary Care MD diagnosed me with COVID after symptoms consistent with the virus on December 14, 2020.

Synthroid 6 am

MALAISE

18-29 years

Jan., 2021

I was pregnant and my baby died two days after I took it and I got really sick

None

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

40-49 years

Dec., 2020

Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.

Environmental stress?

Lexapro, Wellbutrin, synthroid, elequis, ambien,acyclovir

50-59 years

Dec., 2020

none

Jan., 2021

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

Unknown

Jan., 2021

No current illness for this event.

No other medications for this event.

MASTICATION DISORDER

30-39 years

Jan., 2021

Extreme lockjaw unable to barely talk or chew

None

Ritalin, ambilify, propranolol, hydrochlothiazide,.

MASTOID DISORDER

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

MEAN CELL HAEMOGLOBIN NORMAL

18-29 years

Dec., 2020

MEAN CELL VOLUME NORMAL

18-29 years

Dec., 2020

METABOLIC FUNCTION TEST

30-39 years

Jan., 2021

None

Multivitamin

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

60-64 years

Dec., 2020

none

CoQ10, B12, fish oil

METABOLIC FUNCTION TEST NORMAL

30-39 years

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

60-64 years

Dec., 2020

None

Multi vitamen

none

CoQ10, B12, fish oil

MIGRAINE

50-59 years

Dec., 2020

None

Metoprolol, hydrochlorothiazide, Wellbutrin, Celexa, Prilosec

Jan., 2021

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

MOBILITY DECREASED

18-29 years

Dec., 2020

None

40-49 years

Dec., 2020

R/O Covid infection, COVID test was negative December 4, 2020. Primary Care MD diagnosed me with COVID after symptoms consistent with the virus on December 14, 2020.

Synthroid 6 am

No current illness for this event.

SYNTHROID

50-59 years

Jan., 2021

No current illness for this event.

No other medications for this event.

60-64 years

Jan., 2021

Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

No other medications for this event.

MONOPARESIS

65+ years

Jan., 2021

Hypertension, hypothyroidism

No other medications for this event.

MOTOR DYSFUNCTION

30-39 years

Jan., 2021

No current illness for this event.

No other medications for this event.

MUSCLE ATROPHY

40-49 years

Dec., 2020

None

Jan., 2021

None

MUSCLE CONTRACTIONS INVOLUNTARY

50-59 years

Jan., 2021

No current illness for this event.

No other medications for this event.

MUSCLE SPASMS

50-59 years

Jan., 2021

No current illness for this event.

No other medications for this event.

65+ years

Dec., 2020

No current illness for this event.

No other medications for this event.

MUSCLE TIGHTNESS

40-49 years

Jan., 2021

None

MUSCLE TWITCHING

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

MUSCULAR WEAKNESS

18-29 years

Dec., 2020

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

None

Balziva ( birth control )

Birth control

No other medications for this event.

No current illness for this event.

Novolog, Trokendi, Metoprolol, Biotin, Vitamin D, Vitamin C, Potassium

No current illness for this event.

No other medications for this event.

No current illness for this event.

No other medications for this event.

Jan., 2021

NONE

Levothyroxine 200 mcg, Vyvanse 60 mg

40-49 years

Dec., 2020

Soreness and weakness of left arm for more than 5 days. Intermittent headaches and runny nose

No current illness for this event.

No other medications for this event.

Jan., 2021

None

50-59 years

Dec., 2020

No current illness for this event.

vitamin d3 multivitamin calcium fish oil cranberry ambien

No current illness for this event.

No other medications for this event.

MUSCULOSKELETAL DISCOMFORT

30-39 years

Dec., 2020

No current illness for this event.

Novolog, Trokendi, Metoprolol, Biotin, Vitamin D, Vitamin C, Potassium

MUSCULOSKELETAL DISORDER

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

MUSCULOSKELETAL PAIN

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

MUSCULOSKELETAL STIFFNESS

50-59 years

Dec., 2020

NONE

MYALGIA

30-39 years

Dec., 2020

None

Famotidine 40 mg daily, TUMS 1-2 tablets daily prn, APAP 500 mg daily prn, Magnesium tablets 500 mg daily, Voltaren OTC gel apply to affected area daily prn

Jan., 2021

none

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

No current illness for this event.

OMEPRAZOLE

40-49 years

Dec., 2020

Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.

Environmental stress?

Lexapro, Wellbutrin, synthroid, elequis, ambien,acyclovir

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

Jan., 2021

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.

N/A

No current illness for this event.

No other medications for this event.

65+ years

Dec., 2020

had surgery R hand for advanced arthritis 11/16/20 - arthrodesis R thumb. was recuperating

phenobarbital 60mg HS hydroxychloroquin 400mg HS famotidine 20mg HS occas acetaminophen or ibu

Unknown

Dec., 2020

No current illness for this event.

ATORVASTATIN, EPLERENONE, EZETAMIBE, CITALOPRAM, JARDIANCE, ENTRESTO, XARELTO, CARVEDILOL, ASA, FOLATE

MYOCARDIAL INFARCTION

40-49 years

Dec., 2020

I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not sure if these are related but I felt I should report it.

None

Propranolol, Pepcid,cetrizine, losartan

NASAL CONGESTION

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

NAUSEA

30-39 years

Jan., 2021

None

Multivitamin

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

50-59 years

Jan., 2021

No current illness for this event.

No other medications for this event.

60-64 years

Dec., 2020

No current illness for this event.

No other medications for this event.

Jan., 2021

No current illness for this event.

No other medications for this event.

Unknown

Jan., 2021

No current illness for this event.

No other medications for this event.

NECK PAIN

30-39 years

Dec., 2020

None

Balziva ( birth control )

Jan., 2021

None

Multivitamin

40-49 years

Jan., 2021

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

No current illness for this event.

vitamin d3 multivitamin calcium fish oil cranberry ambien

NERVOUSNESS

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

NEURALGIA

30-39 years

Dec., 2020

None

Jan., 2021

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

NEURALGIC AMYOTROPHY

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

None

Balziva ( birth control )

40-49 years

Dec., 2020

None

Jan., 2021

None

NEUROLOGICAL EXAMINATION ABNORMAL

30-39 years

Dec., 2020

Peripheral neuropathy

None

MVI, Vit D, Vit C, quercentin, NAC

NEUROLOGICAL EXAMINATION NORMAL

30-39 years

Jan., 2021

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

NEUROLOGICAL SYMPTOM

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

40-49 years

Jan., 2021

None

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

NEUROPATHY PERIPHERAL

30-39 years

Dec., 2020

Peripheral neuropathy

None

MVI, Vit D, Vit C, quercentin, NAC

Jan., 2021

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

NIH STROKE SCALE ABNORMAL

65+ years

Jan., 2021

Hypertension, hypothyroidism

No other medications for this event.

NONINFECTIVE ENCEPHALITIS

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

OEDEMA PERIPHERAL

60-64 years

Jan., 2021

None

Zoloft 12.5 mg daily

OROPHARYNGEAL PAIN

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

none

PAIN

18-29 years

Jan., 2021

No current illness for this event.

Vraylar 1.5mg daily Trintillix 40mg daily Vyvanse 60mg daily Vitamin C 1000mg daily

None

Pt given Medrol dose pack on 1/10/2021 as well as taking Naproxen. Pt given another dose of Medrol on 1/21/2021

30-39 years

Dec., 2020

No current illness for this event.

Novolog, Trokendi, Metoprolol, Biotin, Vitamin D, Vitamin C, Potassium

No current illness for this event.

No other medications for this event.

Jan., 2021

No current illness for this event.

No other medications for this event.

None

Multivitamin

None

Escitalopram, Tri-Lo-Marzia, Restasis, melatonin, Multivitamin, probiotic

None

Seroquel, lamictal, klonopin, Allegra, vitamin d

D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.

40-49 years

Dec., 2020

No current illness for this event.

No other medications for this event.

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

Jan., 2021

None

50-59 years

Dec., 2020

NONE

Jan., 2021

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

No current illness for this event.

No other medications for this event.

60-64 years

Jan., 2021

None

Zoloft 12.5 mg daily

No current illness for this event.

No other medications for this event.

65+ years

Dec., 2020

No current illness for this event.

No other medications for this event.

No current illness for this event.

No other medications for this event.

PAIN IN EXTREMITY

18-29 years

Dec., 2020

N/A

TriSplintec Oral Contraceptives

Jan., 2021

None

Pt given Medrol dose pack on 1/10/2021 as well as taking Naproxen. Pt given another dose of Medrol on 1/21/2021

30-39 years

Dec., 2020

No current illness for this event.

No other medications for this event.

No current illness for this event.

No other medications for this event.

Jan., 2021

No current illness for this event.

No other medications for this event.

40-49 years

Dec., 2020

Soreness and weakness of left arm for more than 5 days. Intermittent headaches and runny nose

No current illness for this event.

No other medications for this event.

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

None

Jan., 2021

No current illness for this event.

No other medications for this event.

50-59 years

Dec., 2020

No current illness for this event.

No other medications for this event.

none

Jan., 2021

No current illness for this event.

VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;

60-64 years

Dec., 2020

No current illness for this event.

No other medications for this event.

Jan., 2021

None

Zoloft 12.5 mg daily

65+ years

Dec., 2020

had surgery R hand for advanced arthritis 11/16/20 - arthrodesis R thumb. was recuperating

phenobarbital 60mg HS hydroxychloroquin 400mg HS famotidine 20mg HS occas acetaminophen or ibu

Unknown

Dec., 2020

No current illness for this event.

ATORVASTATIN, EPLERENONE, EZETAMIBE, CITALOPRAM, JARDIANCE, ENTRESTO, XARELTO, CARVEDILOL, ASA, FOLATE

PAIN IN JAW

50-59 years

Jan., 2021

No current illness for this event.

metformin 100 mg, Lipitor

PAIN MANAGEMENT

Unknown

Unknown Date

No current illness for this event.

No other medications for this event.

PALLOR

18-29 years

Dec., 2020

N/A

TriSplintec Oral Contraceptives

40-49 years

Dec., 2020

none

multivitamines

50-59 years

Jan., 2021

No current illness for this event.

No other medications for this event.

PANIC ATTACK

40-49 years

Dec., 2020

Long hauler syndrome,

Lyrica, Xanax pen, klonipin prn

PARAESTHESIA

18-29 years

Jan., 2021

None

Pt given Medrol dose pack on 1/10/2021 as well as taking Naproxen. Pt given another dose of Medrol on 1/21/2021

30-39 years

Dec., 2020

None

No current illness for this event.

No other medications for this event.

No current illness for this event.

No other medications for this event.

no other illnesses at this time

none

Jan., 2021

none

No current illness for this event.

OMEPRAZOLE

40-49 years

Dec., 2020

none

multivitamines

Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also my left foot feels like pins and needles.

Had skin infection and took antibiotics 2 weeks prior

Metformin, Valsartan, Adderall, Asprin, Testosterone Enanthate, Anastrozole.

R/O Covid infection, COVID test was negative December 4, 2020. Primary Care MD diagnosed me with COVID after symptoms consistent with the virus on December 14, 2020.

Synthroid 6 am