VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 0990453
Sex: F
Age:
State: IN

Vax Date: 01/13/2021
Onset Date: 01/16/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Rapid onset vaginal yeast infection; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 13Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient experienced rapid onset vaginal yeast infection on 16Jan2021 12:00. It was treated with Diflucan. The patient reported that she gets this reaction when taking antibiotics but the only thing she received was the vaccine. The outcome of the event was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990454
Sex: M
Age:
State: TN

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient receive first dose of bnt162b2 (lot number: EL3249, Pfizer), via an unspecified route of administration in right arm (shoulder) on 16Jan2021 06:30 at single dose for covid-19 immunization. Medical history included hypertension, gout, BP (blood pressure) abnormal, blood cholesterol abnormal all from an unknown date and unknown if ongoing. Concomitant medication included daily losartan for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol. The patient experienced headache, 10 hours later symptoms of fatigue and bell's palsy on 16Jan2021 16:00 about 10 hours after vaccination. Therapeutic measures were taken as a result of events. He was prescribed Prednisone 6 tabs PO (per oral) for 5 days, tapering down 1 tab daily. B12 Shot in 19Jan2021. He had an MRI (magnetic resonance imaging) appointment on 20Jan2021. His BP and cholesterol are both under control. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. No additional vaccines administered on same date of the Pfizer suspect. The adverse event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Family Medical History included: Mother died of cancer in the early 90s. Dad died of heart failure in the early 80s. The outcome of events was not resolved.

Other Meds: LOSARTAN; CRESTOR

Current Illness:

ID: 0990455
Sex: F
Age:
State: AR

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Itchy Rash; fever; debilitating joint pain; nausea; fatigue; headache; inj site pain; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date was not provided), intramuscular (left arm) first dose on 14Jan2021 12:30 at single dose for covid-19 immunisation. The patient's medical history Asthma, adrenal insufficiency, hypokalemia, chronic migraine, Vit D deficiency, Known allergies: IV Contrast dye, and Covid. The patient was not pregnant at time of vaccination. The patient's concomitant medication includes unspecified drug. On 14Jan2021 13:00, the patient experienced itchy rash, fever, debilitating joint pain, nausea, fatigue, headache, and injection site pain. The patient did not received treatment for the events. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0990456
Sex: F
Age:
State: NY

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Chills; Headache; Nausea; Myalgia; Arthralgia; fatigue; pain at site of injection; Start Date/Time: (2nd dose) 15Jan2021 09:00 AM Start Date/Time: (1st dose) 29Dec2020 09:00 AM"; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at her right arm, via an unspecified route of administration on 15Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). Vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose). The patient experienced chills, headache, nausea, myalgia, arthralgia, fatigue, pain at site of injection; all on 15Jan2021 08:00. The patient did not receive any treatment for the events. The outcome of the events was recovering. Information on the batch/lot number has been requested.

Other Meds: LEXAPRO

Current Illness:

ID: 0990457
Sex: F
Age:
State: CA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Headache; Dizziness/Lightheaded; Gait and speech disturbance; Gait and speech disturbance; Tired; Brain fog; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Jan2021 14:30 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included Sjogren's, asthma, low Igg, A-Fib, osteoporosis. The patient has known allergies: Methylparaben, Rocephin, lidocaine, oats. Concomitant medications included metoprolol, hydroxychloroquine sulfate (PLAQUENIL), apixaban (ELIQUIS), propafenone. On 16Jan2021 14:30, the patient experienced Headache, dizziness, lightheaded, gait and speech Disturbance, tired, brain fog. The outcome of the events was unknown. The patient did not receive treatment for the events. Information on the lot/batch number has been requested.

Other Meds: METOPROLOL; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; ELIQUIS; PROPAFENONE

Current Illness:

ID: 0990458
Sex: F
Age:
State: MI

Vax Date: 12/19/2020
Onset Date: 12/20/2020
Rec V Date: 02/01/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: malaise; weakness; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Dec2020 08:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant at time of vaccination. Concomitant medication included linaclotide (LINZESS), omeprazole, ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient previously took erythromycin and DEMEROL and experienced allergy. The day after first injection, patient had extreme malaise, weekness and nausea on 20Dec2020 06:00. Outcome of the event was recovered. No treatment was received for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.

Other Meds: LINZESS; OMEPRAZOLE; VIT C; VIT D

Current Illness:

ID: 0990459
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Severe headache; nausea; fever; chills; body aches; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (left arm) on 23Dec2020 (14:45) at single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, nausea, fever, chills, body aches, and fatigue on 24Dec2020 (12:00AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0990460
Sex: F
Age:
State: MA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Temp max of 103.5, remained elevated from 12 hours post vaccine until 36 hours post vaccine. Remained 100.5; headache; muscle aches; skin tenderness; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on the left arm on 13Jan2021 07:00 at a single dose COVID-19 immunization. Medical history included none. The patient is not pregnant. The patient's concomitant medication includes an unspecified birth control pill. On 13Jan2021 19:00, the patient experienced a temp max of 103.5, remained elevated from 12 hours post vaccine until 36 hours post vaccine. Remained 100.5 with ibuprofen 800 mg and Tylenol 1000mg. The patient also experienced headache, muscle aches and skin tenderness x 48 hours. The patient was given treatment for the events. The outcome of the events was recovered on an unspecified date.

Other Meds:

Current Illness:

ID: 0990461
Sex: F
Age:
State: MN

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Maternal exposure during pregnancy; Maternal exposure during pregnancy; Maternal exposure during pregnancy; Muscle and joint aches in legs; Muscle and joint aches in legs; Shivering; fatigue; This is a spontaneous report from a contactable nurse. A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9231), intramuscular on 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included colitis ulcerative and hypersensitivity to sulfa drugs, tomato, nuts from an unknown date and unknown if ongoing. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]), colecalciferol (VITAMIN D [COLECALCIFEROL]). On 15Jan2021 22:00, the muscle and joint aches in legs, shivering and fatigue. The patient was 35 Weeks pregnant at the onset of the event. The patient was due to deliver on 26Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021 covid test result of Negative. The outcome of the eventsmuscle and joint aches in legs, shivering and fatigue was recovering.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 0990462
Sex: F
Age:
State: VA

Vax Date: 12/21/2020
Onset Date: 12/30/2020
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: tested positive for COVID-19; tested positive for COVID-19; headache; This is a spontaneous report from a contactable nurse (patient herself). A 31-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot EL1283), via an unspecified route of administration in the right arm on 21Dec2020 at SINGLE DOSE, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines in four weeks. She had a sars-cov-2 test via nasal swab on 30Dec2020 and was negative. She was re-tested for sars-cov-2 and she was positive (via nasal swab) on 04Jan2021. The patient had her second dose of bnt162b2 on 15Jan2021. She informed that she had headache that started 30Dec2020 and during the 10 days following the positive test. She received the vaccine in a hospital and had doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of events was recovered.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and a repeated sars-cov-2 test via nasal swab positive on 04Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.

Other Meds:

Current Illness:

ID: 0990463
Sex: F
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/01/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch; pus; arm hurt for a few days but it stopped; This is a spontaneous report from a contactable consumer (reporting for herself). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced arm hurt for a few days, but it stopped and had puss. On 15Jan2021, the patient reported that the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch. Therapeutic measures were taken as a result of the events and included: acetaminophen (TYLENOL). The outcome of arm hurt for a few days but it stopped was recovered in Jan2021 and of the site where the injection was had a round red mark silver dollar sized, it itched and hurt and it was hot to touch and pus was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0990464
Sex: F
Age:
State: MA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Fever of 101.1 degrees Fahrenheit; rigors; body and joint aches; body and joint aches; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: Ek4176), via Intramuscular on right arm on 16Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 29 years old on 25Dec2020 (first dose, Lot number=EH9899, 10:00 AM, Intramuscular on Right arm) for covid-19 immunisation. The patient experienced fever of 101.1 degrees Fahrenheit, rigors, body and joint aches, headache, fatigue 12 hours after vaccination on 16Jan2021 at 10:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. The patient underwent lab test included COVID 19 PCR on 17Jan2021 (covid test result: Pending). The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0990465
Sex: F
Age:
State: MI

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Fatigue; headache; constipation; then extremely loose stools and 1 event of loss of bowel control.; then extremely loose stools and 1 event of loss of bowel control.; This is a spontaneous report from a contactable Other healthcare professional (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration on 13Jan2021 16:00 at single dose in Left Arm for COVID-19 immunization. The patient medical history was not reported. There were no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). There were no other vaccines received in four weeks. The patient did not have COVID-19 prior vaccination and COVID-19 was not tested post vaccination. The patient experienced Fatigue, headache, constipation, then extremely loose stools and 1 event of loss of bowel control on 13Jan2021 17:00, no treatment received for these events. The outcome of the events was unknown.

Other Meds: LEXAPRO

Current Illness:

ID: 0990466
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was spinning; there is not enough spit in my mouth. It's very dry; I walked very slowly; slight headache; My blood pressure now is 137/93. It was high this morning; felt lousy like I had the flu; felt like I was fainting; This is a spontaneous report from a contactable consumer. A 68-years-old female patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included transient ischaemic attack (I had a TIA prior). The patient's concomitant medications were not reported. The patient experienced "feeling a little woozy/dizzy" on an unspecified date with outcome of unknown, "my head was sideways and every time I would raise my head the room was spinning" on an unspecified date with outcome of unknown, "there is not enough spit in my mouth, it is very dry" on an unspecified date with outcome of unknown, I" walked very slowly" on an unspecified date with outcome of unknown, "slight headache" on an unspecified date with outcome of unknown, "my blood pressure now is 137/93. it was high this morning" on an unspecified date with outcome of unknown, "feelt lousy like I had the flu" on an unspecified date with outcome of unknown, "felt like I was fainting" on an unspecified date with outcome of unknown. Reaction description by the reporter:" I had no pain, slight headache. My blood pressure now is 137/93. It was high this morning when I talked with the triage nurse. I had the shot/vaccine (first dose) on Friday. I feel better today than yesterday. Friday I felt fine. I got symptoms yesterday. When I woke up yesterday. I was feeling a little woozy, I always stretch slowly in bed. I slowly raised myself on the bed but before I got up my torso fell backwards. I felt like I was fainting. The room was spinning. All day yesterday I did not drive. I walked very slowly. I was holding onto the wall. I felt lousy like I had the flu. I would lay down for 20 minutes, watching tv. My head was sideways and every time I would raise my head the room was spinning. Also there is not enough spit in my mouth. It is very dry. I had a slight headache. So I did not bother but no headache today. I supposed to get my 2nd dose on 02Feb2021. The action taken was not applicable. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0990467
Sex: M
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Stated that he received the first dose then took the test and it came out positive/got vaccinated 29Dec2020/took the Covid test on 30Dec2020/found out that he was positive on Friday (01Jan2021); Stated that he received the first dose then took the test and it came out positive/got vaccinated 29Dec2020/took the Covid test on 30Dec2020/found out that he was positive on Friday (01Jan2021); This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose then took the test and it came out positive. He was scheduled to take the second dose next Tuesday 19Jan2021 and wanted to confirm if he has to wait 90 days or still stick with the second dose since he has already had the first dose. Patient stated that he had got vaccinated on 29Dec2020. Stated that he took the Covid test on 30Dec2020 because someone tested positive and found out that he was positive on Friday (01Jan2021). He was cleared to return to work and he will tomorrow. He wanted to know if this will impede the vaccination process and wanted to know if he will have to redo the vaccination. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990468
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot do her daily duties/ could not even put her seat belt or roll up the window in her car; extreme headache; received first dose of the vaccine on 24Dec2020/the second dose on 11Jan2021; Chills; feeling horrible/feels foggy; feeling tired/ exhausted; body aches; arm was really sore; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 11Jan2021 07:45 at single dose in left arm to prevent covid, since she worked in a hospital with covid patients. Medical history provided as none. There were no concomitant medications. She gets the flu vaccine annually. The patient previously received first dose of BNT162B2 vaccine intramuscularly on 24Dec2020 23:45 in left arm for COVID-19 immunization with no adverse events. There were no other prior Vaccinations within 4 weeks. The patient experienced chills on 11Jan2021, feeling horrible on 11Jan2021, extreme headache on 12Jan2021, chest discomfort/something heavy on her chest on 13Jan2021, feeling tired/ exhausted on 11Jan2021, chest discomfort, feeling tired/ exhausted was reported as worsened; body aches on 11Jan2021, feels foggy on 13Jan2021, arm was really sore on an unspecified date in Jan2021, cannot even get out of bed on 12Jan2021. Specifically, it was reported that the patient worked 12 hours overnight, she slept and when she woke up she felt chills and felt horrible. States it carried on 12Jan2021. Today on 13Jan2021 she has an extreme headache, she clarifies the headache started on 12Jan2021 (yesterday). She feels like something heavy on her chest, chest discomfort. She has body aches and feels tired. She cannot cook right, she is so exhausted and cannot do her daily duties. She is assuming it is the immune reaction. Her son told her she looks really sick. States she rarely gets sick and when she gets sick she does get chills. Her chest feels like something is heavy on her. States if she did not have a strong heart, she cannot imagine what someone that does not have a strong heart would feel like. Since she works in a hospital she deals with covid all year around and she has been strong and healthy this year. Reports her headache is strong and today on 13Jan2021 she feels foggy. States yesterday on 12Jan2021, she was horrible and today (13Jan2021) is better in regards to chills. Her arm was really sore and now her arm is better, she could not even put her seat belt on 12Jan2021 (yesterday) or roll up the window in her car. She is nervous about the chest discomfort and headache. Asking where it could be coming from. She thinks it could be a possible immune response. If the chest discomfort continues she will go get seen. Advised to contact hcp. States she feels like crap. States she never gets headaches. Yesterday on 12Jan2021, her body aches were horrible and she cannot even get out of bed. The outcome of events chills, body aches was recovering, outcome of events extreme headache, chest discomfort/something heavy on her chest, feeling tired/ exhausted was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990469
Sex: F
Age:
State: NC

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: last night had a violent bout of chills; slight headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 85; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. Medical history included sars-coV-2 virus. The patient's concomitant medications were not reported. Reporter wanted to know if her side effects are normal. Vaccine received at a community center. Patient had been infected with the sars-coV-2 virus several months ago, this past Saturday (Jan2021) she got the first dose of the COVID vaccine series at about 10 AM and last night (Jan2021) had a violent bout of chills which was 6-8 hours after the shot. Also reported a slight headache for which she took 2 ibuprofen, 3 hours later, it struck her like a ton of bricks. She wanted to know if the timeframe for which her side effects appeared is a long time or not. She wanted to know if she should get the second dose of the covid vaccine. She stated "I'm not docking your product, I'm thankful that we have it." She would like to know if her history of being positve for covid infection reacted with her first dose of Covid vaccine. The outcome of the events was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0990471
Sex: M
Age:
State: MO

Vax Date: 01/15/2021
Onset Date: 01/17/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Transient focal swelling of the medial right conjunctiva associated with mild irritation.; Transient focal swelling of the medial right conjunctiva associated with mild irritation.; This is a spontaneous report from a contactable physician (reporting for himself). A 35-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283: expiration date unknown), via an unspecified route of administration in the left arm on 15Jan2021 at 17:00 at a single dose for COVID-19 immunization. Medical history included seasonal allergies and no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included acetaminophen on unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 26Dec2020 at 07:00 PM in the right arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Jan2021 at 18:00, the patient experienced transient focal swelling of the medial right conjunctiva associated with mild irritation. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included diphenhydramine. The events were considered non-serious by the reporter. The outcome of the events was recovered on unspecified date in Jan2021.

Other Meds: ACETAMINOPHEN

Current Illness:

ID: 0990472
Sex: F
Age:
State: WI

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Severe lower back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number Cc3248), via an unspecified route of administration in the left arm on 15Jan2021 at 13:15 at a single dose for COVID-19 immunization. Medical history included being tested for arthritis and allergies (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included prednisone. The patient experienced severe lower back pain on 16Jan2021. The patient did not receive treatment for the event. The patient has not been tested for COVID-19 since the vaccination. Outcome of the event was not recovered.

Other Meds: PREDNISONE

Current Illness:

ID: 0990473
Sex: F
Age:
State: PA

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: nausea; chills; I had a headache within 24 hrs of vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL0140), intramuscular in the right arm on 05Jan2021 at 11:00 AM as a single dose for COVID-19 immunization. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. The patient previously took morphine sulfate and experienced allergies. The patient was not pregnant at the time of vaccination, did not receive any other vaccines within four weeks prior to the COVID vaccine, did not have any other medications within 2 weeks of the vaccination, and was not diagnosed with COVID-19 prior to vaccination. The patient had a headache within 24 hours of the vaccine and then she had nausea and chills on 09Jan2021 at 15:30. The patient underwent lab tests and procedures which included nasal swab for SARS-CoV-2 (COVID-19) test: negative on 13Jan2021. No treatment was given for the events. Outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0990474
Sex: F
Age:
State: IN

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Headache for over a week; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), 1st dose on 19Dec2020 14:45 and 2nd dose on 11Jan2021 08:45; both via unspecified route of administration via the left arm at a single dose for COVID-19 immunization. Medical history included asthma, allergies and COVID-19 (prior to vaccination). The patient is not pregnant at the time of vaccination. Concomitant medication included azelastine hydrochloride (ASTELIN), fluticasone propionate, salmeterol xinafoate (ADVAIR), zafirlukast (ACCOLATE) and omeprazole (PRILOSEC). The patient previously took motelukast (SINGULAIR), dimeticone, glycerol (CETAPHIL) and budesonide, formoterol (SYMBICORT); all for allergy. The patient experienced headache for over a week on 11Jan2021 08:45. No treatment was received for the evet. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Other Meds: ASTELIN; ADVAIR; ACCOLATE; PRILOSEC

Current Illness:

ID: 0990475
Sex: F
Age:
State: MO

Vax Date: 12/26/2020
Onset Date: 12/27/2020
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Left Axilla/Underarm pain; Left Axilla/Underarm swelling; lymph node swelling; pain in neck.; Red rash on both arms, chest.; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 26Dec2020 14:00 at single dose in left arm for COVID-19 immunization. Medical history included complete thyroidectomy in 2000 and known allergies included Sulfa. Concomitant medications included losartan, levothyroxine, thyroid (ARMOUR THYROID). The patient didn't receive other vaccine in four weeks. The patient had no covid prior vaccination and no covid tested post vaccination. The patient experienced left axilla/underarm swelling/pain, lymph node swelling/pain in neck. Red rash on both arms, chest on 27Dec2020. The patient did not receive the treatment for events. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: LOSARTAN; LEVOTHYROXINE; ARMOUR THYROID

Current Illness:

ID: 0990476
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Patient has a red, warm, hard spot in her arm where the second dose was administered; Patient has a red, warm, hard spot in her arm where the second dose was administered; Patient has a red, warm, hard spot in her arm where the second dose was administered; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included overweight. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient has a red, warm, hard spot in her arm where the second dose was administered on unspecified date. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990477
Sex: F
Age:
State: GA

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Bouts of vertigo; Dizziness; Weakness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 52-years-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: e10142) via an unspecified route of administration on 13Jan2021 09:15 at single dose in left arm for COVID-19 immunisation. She received the first dose (Lot number: Ej1658) in left arm on 23Dec2020 06:30 PM for COVID-19 immunisation. Medical history included diabetes, hypertension. The patient was not allergic to medications, food, or other products. Concomitant medication included metformin, metoprolol tartrate (METPROLOL), triamterene, rosuvastatin, pyrvinium (TRU). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the 2nd dose on 13Jan2021, experienced weakness, dizziness and nausea at around noon next day (14Jan2021 12:00 PM) then at around 6:00 pm bouts of vertigo. Up to now 5 day after the onset dizziness and vertigo still present. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for events. Events outcome was not recovered.

Other Meds: METFORMIN; METPROLOL; TRIAMTERENE; ROSUVASTATIN; TRU

Current Illness:

ID: 0990478
Sex: M
Age:
State: NJ

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Since getting first shot and again after the second shot, have had frequent afib/apc's; Since getting first shot and again after the second shot, have had frequent afib/apc's; This is a spontaneous report from a contactable Physician (ophthalmologist) reporting for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: eh9899), intramuscular on 21Dec2020 at 15:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was not receiving concomitant medications. Medical history included ongoing paroxysmal afib (atrial fibrillation). The patient has known allergies to squid. The patient reported having a long history of paroxysmal afib, very fit, play tennis at the national level. Prior to vaccine have had 2-3 brief bouts of afib/year. Since getting first shot and again after the second shot, have had frequent afib/apc's (atrial premature contractions) at least 6 episodes. Adverse event start date was reported as 21Dec2020 at 02:00 AM (pending clarification). No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: The event is considered possibly related to the suspect product based on the reportedly positive temporal association in a subject with a positive medical history of atrial arrhythmias. 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.

Other Meds:

Current Illness: Paroxysmal atrial fibrillation (paroxysmal afib, had 2-3 brief bouts of afib/year.); Seafood allergy (Allergy to squid)

ID: 0990479
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: first dose 23Dec2020, arm sore; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 23Dec2020 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm sore after the first dose on 23Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0990480
Sex: M
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: flu like symptoms for 36-48 hours; injection site pain; pain on the left side, at the armpit; pain in the swollen lymph nodes; pain in the swollen lymph nodes; This is a spontaneous report from a contactable consumer reported for himself. This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 15Jan2021 night at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine on 15Jan2021 night and had a pretty severe reaction (in Jan2021) that were described as flu like symptoms for 36-48 hours. He felt like that's over with now. He got the vaccine on his left arm. The injection site pain lasted for 24 hours. After 34 hours, he had a pain on the left side, at the armpit. He said it got better 36 hours ago. He was wondering if pain in the arm where the shot was administered in the armpits were reported as a side effect and how long will the pain in the swollen lymph nodes last. The outcome of "flu like symptoms" and "injection site pain" was recovered, of "armpit pain" was recovering, of other events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990481
Sex: M
Age:
State: NC

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: pain/ uppper body is very sensitive, sore; skin that is sensitive to touch; blotches on the back and chest; general feeling of tiredness; Headache; muscle aches; Red rash; uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiration date unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced pain/ upper body is very sensitive, sore, headache, skin that is sensitive to touch, blotches on the back and chest, general feeling of tiredness. On an unspecified dates in Jan2021, the patient experienced muscle aches, red rash, and uncomfortable. The patient reported that he did not have any symptoms of the COVID when he got the vaccine shot. He mentioned that he made an appointment to get a test. The outcome of the events skin that is sensitive to touch, muscle aches, red rash was not recovered; while the outcome of the rest of the events was unknown.

Other Meds:

Current Illness:

ID: 0990482
Sex: M
Age:
State: PA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration at the right arm on 16Jan2021 at single dose for Covid-19 immunization in a hospital and not in military facility. The patient's medical history included sinus headache and headaches; both ongoing. The patient informed that he usually gets the sinus headache but wanted to know if this was normal. The patient was getting sinus headaches this time of the year. The patient was taking different medication but was taking sinus medication daily due to the chronic sinus condition. The patient informed that he was seeing an ENT regularly for the headaches and sinus condition. The patient informed that with the flu vaccine he normally has mild flu symptoms for a day. He got the shingles vaccine this fall and he had a more severe reaction with it in terms of flu symptoms. The patient thinks that shingles vaccine was called Shingrix. The patient has no prior vaccinations within 4 weeks. The patient had a headache after the COVID vaccine on Saturday. The patient informed that he got the vaccine on 16Jan2021 at about 10 am or 10:15 am and about 3 pm the headache started, it lasted about 2 hours. The patient had nothing other than the headache and for that he can't say that wasn't his normal sinus headaches he gets normally during this time of the year. The patient explained that the headache occurred later in the day but he can't say it wasn't his normal sinus headaches. The patient informed that the headache wasn't severe, not even a Tylenol was needed, there was no treatment. The patient was scheduled for the second dose on day 20 instead of the 21st day. The patient explained when he got his first shot he was given a window of days to choose from for the second dose. He picked one day which happened to be day 20 after the first dose. The patient informed that he wanted to know if that was ok but was told to check with his physician. The patient didn't want to get it the next day which would be day 21 as he was working that day and didn't want to risk feeling bad, in case there was a side effect. The event did not require a visit to emergency room and physician office. The outcome of the event headache was recovered on 16Jan2021 17:00. Follow-up activities are possible, information on the batch number has been requested.

Other Meds:

Current Illness: Headache (seeing an ENT regularly); Sinus headache (gets normally during this time of the year; taking sinus medication daily; seeing an ENT regularly)

ID: 0990483
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: developed a sore red spot with a burning sensation in the administration site of the vaccine; she developed a sore red spot with a burning sensation in the administration site of the vaccine; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient was concomitantly taking valsartan (manufacturer unknown) for the management of her blood pressure, ibandronate sodium (BONIVA) for her bones, levothyroxine sodium (SYNTHROID) for an unspecified indication and gabapentin (manufacturer unknown) for neuropathy. The patient was also taking dietary supplements (unspecified) to improve her immune system. The patient reported that she developed a sore red spot with a burning sensation in the administration site of the vaccine on an unspecified date. The patient reported that this sore spot does not compromise the movement or her normal activities. The patient expressed her satisfaction with vaccine because it is a grace to have a vaccine that is saving the world. She also wanted to know if it would be appropriate to take Tylenol and if it would be appropriate to attend her therapy of the neck appointment. The patient also wanted information if the COVID-19 vaccine would interact with her medications. The outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: VALSARTAN; BONIVA; SYNTHROID; GABAPENTIN

Current Illness: Blood pressure abnormal; Bone disorder; Immune system disorder (she is currently taking dietary supplements to improve her immune system); Neuropathy

ID: 0990484
Sex: F
Age:
State: CA

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; headache; body aches at the slightest touch; fever; loss of appetite lasting 4 days; left upper arm/underarm/breast swelling and pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiration date not provided), intramuscular in the left arm on 14Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and hypothyroidism. The patient is not pregnant. The patient has no know allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 02:45, the patient experienced nausea, left upper arm/underarm/breast swelling and pain, headache nothing would take away, body aches at the slightest touch, fever, loss of appetite lasting 4 days and still with nausea, loss of appetite and headache. Treatment was not provided in response to the events. The outcome of the events was recovered with sequelae on an unspecified date in Jan2021. The patient has not been tested for COVID post vaccination.

Other Meds:

Current Illness:

ID: 0990485
Sex: F
Age:
State: TX

Vax Date: 12/31/2020
Onset Date: 01/12/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number BNT162b2), at age of 59-year-old via an unspecified route of administration in left arm on 31Dec2020 11:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), valsartan, rosuvastatin (ROSUVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at Time of Vaccination. The patient experienced red rash, bruise, slight nausea, slight feeling of fever but temp registered normal on 12Jan2021 01:00 with outcome of recovering. The patient received topical antibiotic, diphenhydramine (BENADRYL) for treatment. The events resulted in doctor or other healthcare professional office/clinic visit.

Other Meds: SYNTHROID; VALSARTAN; ROSUVASTATIN

Current Illness:

ID: 0990486
Sex: F
Age:
State: MO

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Sore arm at injection site; Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 at 18:30 as a single dose for COVID-19 immunization. Medical history included Sjogren's Syndrome, connective tissue disorder, high blood pressure, was pre-diabetic, and had a known allergy to penicillin. The patient had other medications in two weeks (unspecified). The patient was not pregnant, had no other vaccines in four weeks, and did not have COVID prior to the vaccination. The patient experienced sore arm at injection site on 13Jan2021 at 21:00. The patient did not receive any treatment for the events. She was not COVID tested post-vaccination. Outcome of the event was recovered.

Other Meds:

Current Illness:

ID: 0990487
Sex: M
Age:
State: UT

Vax Date: 12/21/2020
Onset Date: 12/29/2020
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: had 5 nosebleeds in the past 2 weeks; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included asthma and hypertension. Concomitant medication included acetylsalicylic acid (ASPIRIN), atorvastatin, benazepril hydrochloride, hydrochlorothiazide (LOTENSIN HCT), and verapamil. The patient previously took cefuroxime axetil (CEFTIN) and experienced allergy. Patient had 5 nosebleeds in the past 2 weeks on 29Dec2020 12:00, after not having a single one for 10+ years. Nasal saline and Afrin was given as treatment for the event. Outcome of the event was not recovered.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; LOTENSIN HCT; VERAPAMIL

Current Illness:

ID: 0990488
Sex: F
Age:
State: TX

Vax Date: 12/16/2020
Onset Date: 12/19/2020
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: pruritic, textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally/cheeks/chin, forehead, ears, nose. Neck and chest spared/unilateral rash (left side)/Rash was red, splotchy in appearance, and flat; textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally; deeper, maroon discoloration; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route at right arm on 16Dec2020 08:15 AM at single dose for COVID-19 immunization. Medical history included depression, ADHD and known allergies: wasp venom (local swelling and redness). Concomitant drugs included methylphenidate hydrochloride (CONCERTA XL), bupropion hydrochloride (WELLBUTRIN XL), escitalopram oxalate (LEXAPRO), and unspecified multivitamin. No other vaccine in four weeks. Historical vaccine included measles vaccine; mumps vaccine; rubella vaccine (MMR VACCIN) for immunization (allergies: local swelling and redness). Patient was not pregnant. No Covid prior vaccination. On 19Dec2020, patient experienced pruritic, textured rash with redness and warmth on the face bilaterally. Most noticeable on cheeks which at times have had deeper, maroon discoloration. Rash also presented on chin, forehead, ears, and nose. Neck and chest spared. Rash recurred daily. It worsened after a warm shower. Additionally, a unilateral rash (left side) was observed for a few minutes on torso and leg after a warm shower 3 days after vaccine. Rash was red, splotchy in appearance, and flat, resolved within minutes (as reported). Right torso and leg were unaffected. No known changes in skin care routine, regular medication or supplements, exposures, chemicals, or contact. No prior history of rashes described. The local injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising. It was reported events resulted in doctor or other healthcare professional office/clinic visit. Treatments Pepcid, ibuprofen (steroid script was not filled) were received for events. Patient had nasal swab/ nasopharyngeal PCR of covid test on 17Dec2020: negative and on 21Dec2020: negative. Outcome of events was not recovered. Information on the lot/batch number has been requested.

Other Meds: CONCERTA XL; WELLBUTRIN XL; LEXAPRO

Current Illness:

ID: 0990489
Sex: F
Age:
State: KS

Vax Date: 01/12/2021
Onset Date: 01/15/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.

Other Meds: DULOXETINE; MELOXICAM; OZEMPIC

Current Illness: Borderline diabetes; Fibromyalgia

ID: 0990490
Sex: F
Age:
State: WI

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0990491
Sex: F
Age:
State: PA

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: left eye pulsating intermittently; 1st left side of face numb in spots. Now experiencing entire face with 'pins and needles' numbness intermittently; 1st left side of face numb in spots. Now experiencing entire face with 'pins and needles' numbness intermittently; This is a spontaneous report from a contactable nurse (patient). An adult female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL32495121), via an unspecified route of administration in the left arm on 14Jan2021 07:00 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 15Jan2021 09:30, the patient experienced her left eye was pulsating intermittently. First, the left side of face was numb in spots. Now, she experiencing entire face with pins and needles and numbness intermittently. No treatment was received for the adverse events. Outcome of the events was not recovered.

Other Meds: CLARITIN-D

Current Illness:

ID: 0990492
Sex: F
Age:
State: SC

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Sick; Got real weak; Just did not feel right; Aching; Headache; Fatigue; Drowsiness; This is a spontaneous report from a contactable consumer (patient herself). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. Patient stated she got sick after the shot on 14Jan2021 and she got her first Covid vaccine on Thursday 14Jan2021, she did not know how to get an appointment, said to make an appointment for her second dose, stated she tried to make an appointment for 04Feb2021 and they told her everything was booked, caller was looking for availability of the vaccine in her area, stated she cannot drive all the way to get the second vaccine. She had some aching, headache, fatigue, drowsiness and got real weak and just did not feel right on 14Jan2021. She stated she really wanted the vaccine because they have lost 5 people in her neighborhood to Covid. Caller wanted to know if she should still feel the side effects if that was normal and if when she got the second dose will she be safe from Covid. Caller stated she was still having headache today. Her daughter was nurse and she said those were normal side effects of the shot. She did not want to report this. She was better than she was on Thursday. She was not calling to report anything. She was calling because she was supposed to get the second shot. Outcome of fatigue, drowsiness, sick and not feel right was unknown, outcome of other events were not recovered.

Other Meds:

Current Illness:

ID: 0990493
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: dizzy; tingling sensation in the leg; left side of her leg was sore; discomfort in buttock area; left side of my body is sore, mainly the back and pelvic hip area; left side of my body is sore, mainly the back and pelvic hip area; left side of my body is sore, mainly the back and pelvic hip area; left side of my body is sore, mainly the back and pelvic hip area; muscle soreness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on an unspecified date (reported as 'Wednesday') at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient noticed that within 15 minutes of receiving the vaccine, she started feeling dizzy. The left side of her leg was sore. The left side of her body is sore, mainly the back and pelvic hip area. She feels a tingling sensation in the leg. She has discomfort in buttock area. The patient wanted to know if these side effects were associated with the vaccine. She wanted to knowif the muscle soreness can happen immediately after receiving the vaccine. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990494
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: couldn't sleep; sudden hearing loss; complete hearing loss a few days later/hearing loss in right ear; constant humming in her right ear/getting hissing in my ear; arm felt tender; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was either: EL1283, CL1283, or LL1283) on 11Jan2021 at 11:00 at single dose in left arm for COVID-19 immunization. Medical history was none. There were no concomitant medications. Patient previously took pneumonia shot on an unknown date and flu shot in Oct2020 for immunization. Patient got the first dose of the vaccine on 11Jan2021 at 11:00 in the morning. On 11Jan2021 her arm felt tender where the needle went in.On 12Jan2021 late afternoon, she started getting hissing in her ear that was still there and had not gone away at all and she also had a constant humming in her right ear. By 13Jan2021, she still had the humming. She saw an ENT on 13Jan2021 and doctor didn't know if it was correlated to the vaccine or not; doctor took some wax out of her ear and she seemed to get relief from the hissing for about 15 minutes but about 15-20 minutes later the hissing/ humming continued. On 14Jan2021, woke up with complete deafness in right ear. Immediately called ENT doctor and did a hearing test. Patient could not hear and they confirmed she had sudden hearing loss in her right ear on 14Jan2021, she had nothing in her right ear (as reported). They put her on 40 mg a day of Prednisone (20mg tablets) and so far, prednisone hadn't done anything: originally taking prednisone 40mg for four days and was taking two a day; on 16Jan2021 when she was getting no relief and couldn't sleep due to the humming in her ear, she called doctor and was advised to take the 40mg together in the morning, she will take 40mg a day. On 19Jan2021 she took 20mg for four days and then decreased by half again. She was also advised by doctor to take 25mg Benadryl (UPC: 30048284 Lot: SPS023 Exp: Jun2022) at night. They are scheduling her for an MRI in Jan2021.Patient was also scheduled for the second dose on 01Feb2021 and will be on the prednisone until 26Jan2021; she would like to know whether the prednisone will diminish the effectiveness of the vaccine. She also asked if there was a certain amount of time she should wait to restart in case the doctor decided she should not get the second dose; she also wanted to know if she should wait on the second vaccine and maybe start over in two months.She was concerned and wanted to know if she should proceed with the second shot. The patient underwent blood work on an unspecified date to see if she can receive contrast for an MRI. She never had problem with MRI contrast before. Final outcome of the events was reported as unknown.

Other Meds:

Current Illness:

ID: 0990495
Sex: F
Age:
State: TX

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (felt like all my internal organs are frozen cold); heartbeat sounded strong beats (can feel the pump); Body weakness; muscle weakness; It felt heavy and temporary unable to raise; This is a spontaneous report from a contactable consumer reported for herself. This 55-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 14Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced severe dizziness (BP normal at 120/80), nausea, body pain, while sideways lying down: unable to raise right foot or raise her foot. It felt heavy and temporary unable to raise for two days, severe chills (felt like all my internal organs are frozen cold), heartbeat sounded strong beats (can feel the pump) for at least 2 days, body weakness or muscle weakness.Start date for all events were 14Jan2021. Meclizine 25mg was received as treatment. The patient had no Covid tested post vaccination. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no known allergies. The patient had all normal from blood glucose of 109 and bp 120/80 on 14Jan2021, day of vaccine was a perfect day. Outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0990496
Sex: F
Age:
State: FL

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: diarrhea; gastrointestinal distress; fatigue; headache; a sore arm, quite sore; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced the typical side effects within 2 days of the COVID-19 vaccine (1st dose): The first day (14Jan2021) she experienced a sore arm, quite sore, the day after (15Jan2021) she noticed fatigue and headache. The patient had diarrhea on an unspecified date. These symptoms improved by the end of the 2nd day, but she was not 100% (better) yet. The patient experienced gastrointestinal distress on 18Jan2021. The outcome of the event gastrointestinal distress was unknown, of events sore arm, quite sore, fatigue, headache and diarrhea was recovering. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 0990497
Sex: F
Age:
State: FL

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: nauseous; threw up all day; heart races a little bit in the middle of the night/her heart also went racing a few times in the night; sinus pain; dizziness/like she was not dizzy today like she was yesterday, but today she was just more like lightheaded; Low grade fever; feeling sick/doesn't feel good; head hurts really bad/terrible headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EH9899, expiration date Mar2021) via an unspecified route of administration on 09Jan2021 at a 0.3mL via injection into the left arm for covid-19 immunization. The patient stated that she had Type 2 diabetes which diagnosed about 10 years ago and high blood pressure diagnosed about 20 years ago, so her providers office sent her a text saying the doctor wanted her to have the vaccine. She confirmed that she had no other vaccines on the same day as the COVID vaccine. The patient stated that she had high cholesterol about 5 years ago and her doctor initially put her on Lipitor, but she got to a point where she could not walk, so her doctor put her on something else, but she could not tolerate that either, so then she was switched to the Pitavastatin Calcium. The patient stated that she also had a very sensitive stomach, but she cannot think of the name of what she was diagnosed with because since she had her a couple of seizures started about two years ago this upcoming Aug, she can't think straight. The patient also had GERD about 5 years ago, macular degenerative disease a couple of months ago. All medical condition was still ongoing. Current concomitant medications included levetiracetam (KEPPRA, Tablet) 500mg, once daily, by mouth started from about two years ago, this upcoming Aug for seizures; metformin 1000mg, two tablets daily, by mouth started from about 10 years ago for Type 2 diabetes; allopurinol Tablet 300mg, once daily, by mouth started from probably 2 or 3 years ago for her kidney; metoprolol tartrate (LOPRESSOR, Tablet) 50mg, once daily, by mouth started from 2 years ago for high blood pressure; empagliflozin (Jardiance, Tablet) 25mg, once daily, by mouth has been on this product about 6 months for Type 2 diabetes; lisinopril Tablet 40mg, once daily, by mouth started from probably about 10 years ago for high blood pressure; diltiazem hydrochloride (CARDIZEM CD, 24 hour Capsule) 180mg, once daily, by mouth started from a couple years ago; omeprazole magnesium (Prilosec, Capsule) 20mg, once daily, by mouth started from probably about 4 years ago for GERD; hydrochlorothiazide Tablet 25mg, once daily, by mouth started probably about 10 years ago for high blood pressure; Vitamin D 125mcg or 5000unit Tablet, once daily, by mouth as Vitamin supplementation started taking this about a year ago. The patient had a blood test where her Vitamin D was a little low. Vitamin C was got it over the counter; PreserVision OTC medication, with Vitamin A, E, C, zinc and copper Two capsules by mouth daily started from about two months ago for macular degenerative disease; pitavastatin calcium Tablet 2mg, once nightly, by mouth for High cholesterol; it was on it before, but started back on it a couple months ago. The patient reported she doesn't feel good and got headache on 11Jan2021, had dizziness and low grade fever on 15Jan2021, had nausea and threw up, sinus pain and heart races a little bit on 17Jan2021. She did not want to go through this again. The patient stated that she had the first shot of the Pfizer COVID Vaccine on 09Jan2021. She felt for a day and a half by Monday, 11Jan2021, she has been sick ever since, she did not feel good at all. She had a terrible headache, and for probably one or two days, she ran a low-grade fever. Her headache was still ongoing, but it had eased up because she was taking Tylenol. The patient stated that the dizziness she had, caused her to be nauseous and she threw up all day yesterday. She tried to eat something today and she was just having bad problems with feeling sick all the time. She asked if there are recommendations for getting the second shot after having symptoms like this. Today is the third day that she had been feeling the dizziness and it had improved a little, like she was not dizzy today like she was yesterday, but today she was just more like lightheaded. The patient reported that the nausea was ongoing, she felt like she was going to get like today like she did yesterday. She did not think she still has a low grade fever, she probably had the low grade fever on 15 and 16Jan2021. She just can't seem to shake not feeling good. At first that it was her sinuses because that was where her head was hurting, but then the sinus pain went away but she still had a headache. The patient stated that her heart also went racing a few times in the night. Yesterday was a bad day, but today she was a little bit lightheaded. She tried to eat some toast today, so she will see if she can keep that down. The outcome of the events headache, dizziness, heart rate increased and sinus pain was recovering and the low grade fever was recovered on 17Jan2021 and other events was not recovered.

Other Meds: KEPPRA; METFORMIN; ALLOPURINOL; LOPRESSOR; JARDIANCE; LISINOPRIL; CARDIZEM CD; PRILOSEC [OMEPRAZOLE MAGNESIUM]; HYDROCHLOROTHIAZIDE; PRESERVISION; PITAVASTATIN CALCIUM; VITAMIN D [VITAMIN D NOS]; VITAMIN C [ASCORBIC ACID]

Current Illness: Blood pressure high (Diagnosed: About 20 years ago.); Gastric disorder; GERD (Diagnosed: About 5 years ago.); High cholesterol (Diagnosed: About 5 years ago.); Macular degeneration (Diagnosed: A couple of months ago.); Seizures (Caller states that the seizures started about two years ago this upcoming Aug.); Type 2 diabetes mellitus (Diagnosed: About 10 years ago.)

ID: 0990498
Sex: F
Age:
State: CA

Vax Date: 01/08/2021
Onset Date: 01/01/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: could not get out of bed; whole body aches; shaking; significant nausea; significant dizziness; headaches; immediate reaction up to jaw, ear and shoulder/ she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands; not feeling well; very stressful; This is a spontaneous report from a contactable consumer for herself. A 53-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly at upper left arm, 12:45PM on 08Jan2021 to prevent Covid. The patient had no medical history. She did not get sick and had not taken a sick day in 5 years. Patient had not received other vaccines within four weeks. Patient had no concomitant medications. The patient had an immediate reaction up to jaw, ear and shoulder following first dose on 08Jan2021. When she got the injection, she could feel the stuff going in and something on the left side of her jaw, and she brought her right hand up to rub her jaw. She was not sure if a nerve may have been hit, but she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands. This has recovered completely at the time of reporting. She had not been feeling well since that day and got worse. On Wednesday (13Jan2021), it started with significant dizziness and her headaches started toward the end of day. By Thursday (14Jan2021) she had the headache and significant nausea. The body aches started on Thursday. Her whole body ached so much that she was shaking. On Friday (15Jan2021) she could not get out of bed since the headache was intense along with the dizziness and nausea. She received Advil and Tylenol as treatment and was also taking clonazepam since it had been very stressful. She was worried since she felt safe going in to get the vaccine and she did not feel so safe now. At the time of reporting, she improved but not recovered. She would like to know what she is experiencing is a side effect or if she should be tested for Covid. The outcome of tingling feeling resolved, stressful was unknown and outcome of other events was resolving. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990499
Sex: F
Age:
State: MO

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees Fahrenheit; arm pain; sweating; she was really tired; This is a spontaneous report from a contactable nurse. This 49-year-old female nurse reported for herself that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982) at single dose for Vaccination on 14Jan2021. The vaccine was injected to left deltoid/shoulder about 2:15 pm. Relevant medical history included ongoing uterine fibroids since Dec2019, ongoing obesity since Oct2000 and COVID-19 from Dec2020 to Dec2020. Relevant concomitant drug was unknown. The patient had surgical procedures when she had her first child. No Family Medical History Relevant to AE(s). Her mother got the shot a couple of days before caller did and she had no problems. The patient was administered her first dose of Pfizer BioNTech COVID-19 Vaccine on 14Jan2021. She reported that she became sick (Medically significant) about 12 hours later on 15Jan2021. The patient Went to sleep and woke up about 12 hours after she got the Pfizer-BioNTech COVID-19 Vaccine with a body temperature of 102 degrees Fahrenheit and arm pain. She could not really go back to sleep. When she got up it went away. She tried to go to work that day, and did go to work but she was really tired. When she finally got home she got in the bed and really had not been out of bed since then except for today she was sitting in a chair; so she thought maybe she had improved a little bit at on the reporting day. She had maintained a constant fever since 15Jan2021 that had gotten as high as 103 degrees Fahrenheit. At the reporting time her temp was 100.5. She had alternated Tylenol and Motrin for the fever. She was sweating profusely so it may be the temperature trying to break, but she had been struggling since she had it. This was so unlike her, she did not just stay in bed. She could not kick it. She had been unable to work since 15Jan2021 and she had to work tomorrow. She believed this was medically significant because she cannot work. The patient did not have vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Additional Vaccines was administered on Same Date of the Pfizer Suspect. Relevant Tests was None. The patient did not visit the emergency Room nor Physician Office due to the events. The outcome of event being sick was resolving. The outcome of event temperature had gotten as high as 103 degrees Fahrenheit was not resolved. The outcome of other events was unknown. The patient thought the causality was yes 100% because her COVID-19 symptoms were not even this bad; she never had a fever with COVID-19; and she had never before had a fever this high for this long.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the event; causality therefore 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.

Other Meds:

Current Illness: Obesity; Uterine fibroids

ID: 0990500
Sex: F
Age:
State: CA

Vax Date: 01/14/2021
Onset Date: 01/18/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Developed swollen lymph node on left clavicle four days after the second vaccine.; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EJ1686, expiry date: not reported), intramuscular on 14Jan2021 14:15 at a single dose on left arm for covid-19 immunization. Medical history included Lupus, kidney transplant. Patient has known allergies Known allergies: Ciprofloxacin, which she got hives with certain cereals and certain granolas. Patient had his first dose of BNT162B2 COVID-19 vaccine (lot number: Ek5730, expiry date not reported) administered on 22Dec2020 03:00PM intramuscular on left arm. No other vaccine was given in four weeks. The administration was given in a facility type such as hospital. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE), tacrolimus, prednisone, amlodipine, metoprolol, losartan; all on unspecified date for unspecified indications. The patient developed swollen lymph node on left clavicle four days (18Jan2021) after the second vaccine. No treatment was given. Patient has not rested positive COVID prior and post vaccination. Outcome of the event was not recovered

Other Meds: MYCOPHENOLATE; TACROLIMUS; PREDNISONE; AMLODIPINE; METOPROLOL; LOSARTAN

Current Illness:

ID: 0990501
Sex: F
Age:
State: NJ

Vax Date: 01/14/2021
Onset Date: 01/17/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiry date: not reported), intramuscularly, on 14Jan2021 11:15, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered a clinic, not a facility vaccination. There were no additional vaccines administered on same date of the bnt162b2. The patient did not receive other vaccinations within 4 weeks prior to receiving bnt162b2. Medical history included high blood pressure, obesity (has obesity but does not have diabetes), and menopause (10 years). Family history was none. Concomitant medications included metoprolol succinate (METOPROLOL SUCCINATE) for high blood pressure (been taking for 10 years). The patient experienced fatigue on 17Jan2021 10:00 after receiving the first dose of the covid vaccine on Thursday 14Jan2021 11:15. She received her first shot on Thursday (14Jan2021) and everything was fine. She was just experiencing a little bit of fatigue. She would like to know if you would get side effects immediately or after a few days. She wants to know when the side effects typically start after receiving the vaccine. Outcome of the event was recovering.

Other Meds: TOPROL XL

Current Illness:

ID: 0990502
Sex: F
Age:
State:

Vax Date: 01/17/2021
Onset Date: 01/01/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: feeling sick to her stomach; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the covid vaccine and reported feeling sick to her stomach afterward (Jan2021). The patient also had a question about the dosing schedule, and was asking if the second dose should be scheduled for earlier than 21 days. She reported that she got her first dose on 17Jan2021 and was scheduled to have her second dose on 04Feb2021. Outcome of the event feeling sick to her stomach was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990503
Sex: M
Age:
State: NY

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 02/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: severe rigors; massive headache; extreme nausea; horrible arthralgia such that I could not get out of bed; This is a spontaneous report from a contactable physician (patient). A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 13:15 at single dose (Lot number= EL3246) on Left arm for covid-19 immunisation. Medical history included hypertension (HTN), covid prior vaccination. Known allergies: Yes. The patient previously took first dose of bnt162b2 (Lot number= EK9231) on 26Dec2020 01:15 PM Left arm for COVID-19 immunization. The patient experienced on 17Jan2021 02:00 AM reported as "14 hours after vaccine awakened with severe rigors, massive headache, extreme nausea and horrible arthralgia such that I could not get out of bed. Lasted several hours. Arthralgia then abated sufficiently enough to get medicines in bathroom". Treatment received included Anaprox, Nexium. Outcome of events was recovered. No covid tested post vaccination.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm