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: 1010804
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: Vomiting; Not feeling well; nausea; Confusion; Potential cognitive issues and having trouble finding words; Potential cognitive issues and having trouble finding words; This is a spontaneous report. A contactable consumer (patient's daughter) reported that a female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history, concomitant medications and investigation assessment were not reported. It was reported that on 22Jan2021, patient was vomiting and not feeling well. Reporter wanted to see if this was a side effect or something different. It was more than just vomiting. The patient was vomiting and not feeling well, but was also having confusion and potential cognitive issues in Jan2021. Patient was having trouble finding her words in Jan2021. Reporter was trying to figure out how emergent the symptoms were and if it was related to the vaccine and also wanted to know if the nausea in Jan2021 was a side effect. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1010805
Sex: F
Age:
State: TX

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: Extremely tired/fatigue; Low grade fever; chills; Dizziness; This is a spontaneous report from a contactable consumer reported for herself. This 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, Expiry date: 30Apr2021) in right arm on 21Jan2021 4:30pm for COVID-19 immunization. None medical history nor concomitant medications. Patient got her of the vaccine around 4:30pm. They made her stay there for about 15 minutes to make sure she didn't have any kind of reaction. She got home and went right to bed early around 10pm. The next day she was extremely tired, and had difficulty getting up in the morning; has fatigue. She also thinks she has a low grade fever because she has the chills, but she doesn't have a thermometer to check her temperature. She also has some dizziness. Her dizziness has improved, but she still doesn't feel comfortable driving. No emergency room or physician office visit. The outcome of fatigue was not recovered, of other events was recovering.

Other Meds:

Current Illness:

ID: 1010806
Sex: M
Age:
State: KY

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: Fever; Chills; his face was burning up; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via unspecified route of administration on left arm on 22Jan2021 at 08:15 AM at single dose for COVID-19 vaccination. The relevant medical history included three stents in his heart, allergy and medication for cholesterol (he just quit the medication, it was killing his legs). They have tried him on them 99 times but he cannot take statin drugs, they cripple him. Concomitant medications were reported as none. The patient previously took Claritin (doesn't know if he took this for food or medication allergies, he thought it was for sinus drainage most of it). The patient said he got his COVID shot and had a fever of 102 and he had chills with it too on 22Jan2021. He said he was wondering what he was supposed to do to get that fever down, which he clarified it was 102.4 degrees Fahrenheit. The fever started by the time he got back, it was a 2.5-3 hours drive, his wife checked his temperature about 5 minutes prior for the first time, because his face was burning up. He says that the NDC is not written on the vaccine card with the other handwritten information, it did say he went back 12Feb for the second one. He had not started any new medications or received any recent vaccinations. The patient underwent lab test included temperature elevation which showed 102.4 degrees Fahrenheiton on 22Jan2021. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1010807
Sex: M
Age:
State: LA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 02/08/2021
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: felt scratchy in the throat; nose started running more/ nose was like a faucet, non stop, clear; sneezing non stop; injection site was sore; can't taste; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her Doctors PA told her that they got off the phone with another gentleman that was 80 y/o who had the same symptoms and he got the vaccine 1 week ago. On an unspecified date the patient experienced felt scratchy in the throat, nose started running more/ nose was like a faucet, non stop, clear, sneezing non stop, injection site was sore and can't taste. Outcome of the events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058185 same drug, similar events, different patients

Other Meds:

Current Illness:

ID: 1010808
Sex: M
Age:
State: TN

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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: nausea; This is a spontaneous report from a contactable consumer. A 78 years old male consumer (patient) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Historical Vaccine was first dose of BNT162B2 and experienced sore arm. Patient had a wave of nausea 1 hour after the second shot. Outcome of the event was unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1010809
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went to bed and slept for 12 hours; muscle aches; nose was crusty; discharge from her nose, bloody/it was a little bloody; inflammation; cold; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 15Jan2021 at single dose for covid-19 immunization. There were no concomitant medications and medical history. She had still has a sore throat, it has been a week since her first injection, and she immediately like got a sore throat straightaway, then drainage, and she was really tired and had to go to bed in about 4 hours. She couldn't stay awake 4 hours after, she went to bed and slept for 12 hours after the first shot. There was discharge from her nose, bloody, crusty like a cold, and she seldom ever has a cold and that continued, she didn't feel good until about maybe 4 or 5 days later. Sore throat was immediately after she thinks, it was certainly the next day (16Jan2021), and her date of vaccine was 15Jan2021. Now states and cough developed not until later. On 15Jan2021, she had the shot, she was really tired, muscle aches, the kind of things on the sheet, if not that evening, but the next day (16Jan2021), then drainage, it was white at first, it didn't turn yellow until a few days later, had a yellowish tinge, so she is sure there was inflammation, and her nose was crusty, in the morning it was a little bloody, and she had a sore throat, and probably by the Wednesday or Thursday, so 20 or 21Jan2021, there was a little cough, in the evening, and she is not experiencing that today. The outcome of the event sore throat was not recovered, cough was recovered on 22Jan2021, cold was recovering, other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1010810
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/08/2021
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: joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection site pain; Headache; Muscle pain; tired; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the left arm, on 13Jan2021 14:30 at single dose for Covid-19 immunisation . Medical history included cyclic neutropenia from 1998, thyroid disorder from 2001. There were no concomitant medications. The patient experienced feeling sick on 13Jan2021 with outcome of recovering , injection site pain on 13Jan2021 with outcome of recovering , headache on 13Jan2021 with outcome of recovering , muscle pain on 13Jan2021 with outcome of recovering , tired on 13Jan2021 with outcome of recovering , splotches on both cheeks on 14Jan2021 with outcome of recovering , dizzy on 16Jan2021 with outcome of recovering , face a little swollen on 16Jan2021 with outcome of recovering , joint pain on an unspecified date with outcome of recovering , burned on 13Jan2021 with outcome of recovering. The patient received ibuprofen 400 mg to treat headache, muscle pain, joint pain. The patient is not sure if LOT number is EL1283 or EC1283. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1010811
Sex: M
Age:
State: KY

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/08/2021
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: a rash all over my body with yellowish raised skin/bumps; a rash all over my body with yellowish raised skin/bumps; Severe shivering and chills; 5 different fevers; Body aches; Headache; Loss of appetite; Fatigue; This is a spontaneous report from a contactable other HCP reporting for himself. A 28-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EK9231) vaccine , via an unspecified route of administration in the left arm on 05Jan2021 at single dose for covid-19 immunisation . Medical history included , type 2 diabetes mellitus , sinus arrhythmia, gout. Concomitant medication included atenolol (ATENOLOL). The patient previously took lisinopril and experienced drug hypersensitivity, on 15Dec2020 the patient received the first dose of bnt162b2 for covid-19 immunisation and complained from headache, and hyperhidrosis. The patient experienced severe shivering and chills on 05Jan2021 23:30 with outcome of recovering , fevers on 05Jan2021 23:30 with outcome of recovering , body aches on 05Jan2021 23:30 with outcome of recovering , headache on 05Jan2021 23:30 with outcome of recovering , loss of appetite on 05Jan2021 23:30 with outcome of recovering , fatigue on 05Jan2021 23:30 with outcome of recovering , a rash all over my body with yellowish raised skin/bumps on 21Jan2021 with outcome of recovering. The patient received Prednisone and Benadryl as treatment. No follow-up attempts are possible. No further information is expected.

Other Meds: ATENOLOL

Current Illness:

ID: 1010812
Sex: F
Age:
State: PA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: my nose was significantly swollen; This is a spontaneous report from a contactable other health professional (patient). A 27-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EK4176), intramuscular in left arm on 21Jan2021 09:00 at single dose for covid-19 immunization. Medical history included eczema from an unknown date and unknown if ongoing, GERD (gastrooesophageal reflux disease) from an unknown date and unknown if ongoing, allergies: Penicillin from an unknown date and unknown if ongoing, septorhinoplasty on 06Jan2021. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), ibuprofen (MOTRIN), gummy multivitamin. The patient previously took azithromycin and experienced allergy. The patient previous received first dose of bnt162b2 (lot number: EK5730), intramuscular in left arm on 31Dec2020 09:15 AM at single dose for covid-19 immunization. The patient experienced her nose was significantly swollen on 22Jan2021 06:30. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received for adverse event. The patient was a healthcare professional reporting her side effects after vaccine. She had a septorhinoplasty on 06Jan2021. Two weeks after her procedure, her nasal swelling significantly decreased. She returned to work and received her second vaccine on 21Jan2021 at 09:00. When she woke up on 22Jan2021 at 06:30, her nose was significantly swollen, which she believed to have been a reaction to the vaccine. No other breathing problems resulted. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of event was resolving.

Other Meds: ALLEGRA; MOTRIN [IBUPROFEN]

Current Illness:

ID: 1010813
Sex: F
Age:
State: NC

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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: Loss of taste; This is a spontaneous report from a non-contactable consumer reporting for herself. A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EL3247), via an unspecified route of administration in the right arm, on 21Jan2021 at 08:00, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced loss of taste on 21Jan2021 at 18:15 with outcome of recovered in Jan2021. No therapeutic measures were taken as a result of the event. Patient did not have COVID-19 prior to vaccination, and was not tested for COVID-19 after vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1010814
Sex: F
Age:
State: TX

Vax Date: 01/19/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: Red rash that is about the size of her palm/Rash is red and warm to the touch; Rash itches a lot; Rash is red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. The patient had a regular routine appointment to the HCP on Monday. The patient medical history and concomitant medications were not reported. The patient noticed every day she had a red rash that was about the size of her palm. Rash itches a lot. Rash was red and warm to the touch. The patient wanted to know should she be concerned and what to do to get rid of it or should she ignore it. She did not think she was going to die, it just kept continuing. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1010815
Sex: F
Age:
State: MI

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: tachycardia HR into 140s; numbness and tingling around lips; numbness and tingling around lips; warm flushing; This is a spontaneous report from a contactable nurse (patient). This 35-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) intramuscular, in left arm, on 22Jan2021 at 08:00, for COVID-19 immunization. No other vaccine was given on the same day or in 4 weeks. The patient received the first dose of BNT162B2 vaccine on 04Jan2021 at 03:00 PM, lot number EK9231, intramuscular, in left arm. Medical history included Crohn's disease. The patient had no COVID before vaccination. Concomitant medication included azathioprine (IMURAN) at 150 mg, daily. On 22Jan2021 the patient experienced warm flushing within 5 minutes of vaccination and at 08:15 tachycardia (HR into 140s), numbness and tingling around lips. The events required Emergency room/department or urgent care and treatment with diphenhydramine (BENADRYL) 25 mg IV. COVID was not tested after vaccination. The events were resolving.; Sender's Comments: Based on a compatible temporal association, causality between events tachycardia (HR into 140s), numbness and tingling around lips and warm flushing and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: IMURAN [AZATHIOPRINE]

Current Illness:

ID: 1010816
Sex: F
Age:
State: MI

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/08/2021
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: soreness at site; swelling at site; fatigue (slept for 12 hours next night); abdominal pain; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) intramuscular at single dose for COVID-19 immunisation on 20Jan2021, at 05:30 PM. The patient did not receive other vaccine same date. Relevant history included apnea, depression, high blood pressure, reflux, 2 strokes, restless legs and allergies with Clarithromycin, compazine, Hydrocodone; kiwi, peppers. The patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. The patient did not have COVID test post vaccination. Relevant concomitant medications in two weeks includes amlodipine, atorvastatin, duloxetine, plus more. The patient did not receive other vaccine in four weeks of vaccination. The patient experienced soreness at site, swelling at site, fatigue (slept for 12 hours next night); abdominal pain (may be unrelated) since 20Jan2021 at 08:00 PM. The events reported as non-serious. Treatment therapy included Acetaminophen. Outcome of events was resolved. Information about lot/batch number has been requested.

Other Meds: AMLODIPINE; ATORVASTATIN; DULOXETINE

Current Illness:

ID: 1010817
Sex: F
Age:
State: NY

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: fever; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient's friend). A 32-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 21Jan2021 in the Left arm at single dose for COVID-19 immunization in hospital. Medical history included she had a negative pregnancy test before getting the first vaccine dose, but then had a positive pregnancy test a few days after the first dose. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications 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); Iron. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), on 31Dec2020 in the Left arm at single dose for COVID-19 immunization at the age of 32-year-old and had mild symptoms after first dose, but unfortunately she had a miscarriage about 5-6 days before her second dose. After second dose in Jan2021 she experienced worse symptoms such as fever, chills, nausea and fatigue. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, patient had not been tested for COVID-19. Events were resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. The outcome of the events was recovering.

Other Meds: IRON; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness:

ID: 1010818
Sex: F
Age:
State:

Vax Date:
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: covid tested post vaccination, tested positive in PCR test, 7 days after receiving second dose; covid tested post vaccination, tested positive in PCR test, 7 days after receiving second dose; This is a spontaneous report from a non-contactable consumer. A 31-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose, second dose via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient didn't get covid prior vaccination. Covid was tested post vaccination and tested positive in PCR test in Jan2021, 7 days after receiving second dose. There was no treatment received. The patient underwent lab tests and procedures which included PCR test: positive in Jan2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1010819
Sex: F
Age:
State: AK

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: Tired; dizzy; nauseated; shivery; could not even stay awake; This is a spontaneous report from a contactable nurse. This 84-year-old female nurse (Patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunication on 14Jan2021. Relevant history included Atrial fibrillation, Rheumatic heart disease several years ago and needed a pacemaker, getting shingles and ongoing, Congestive heart failure, she got really bad 2.5 years ago after she got the flu and it affected her flu. Relevant concomitant drugs were unknown. The patient stated she got the vaccine on 14Jan2021 (a week ago). She got really tired, stated she slept 9 hours, she was dizzy, nauseated and shivery which started yesterday or the night before, she was really tired for about 3 days after the vaccine, could not even stay awake. Exact dates were not provided. The symptoms were somewhat improved. She took some meclizine and it helped some. She wanted to know if these were side effects of the vaccine. Outcome of events was resolving. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Shingles (States she keeps getting shingles, clarifies not after vaccine, before)

ID: 1010820
Sex: F
Age:
State: TX

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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: soreness of arm after first dose of covid vaccine; This is a spontaneous report from a contactable consumer (patient). This 82 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on 21Jan2021 via unknown route of administration at single dose on left arm for COVID-19 immunisation. Relevant medical history included back problems which was diagnosed prior to receiving the Covid vaccine and was treated with epidural injection with no side effects. Relevant concomitant medication were not provided. The patient reported that he received first dose of COVID-19 vaccine on 21Jan2021and experienced soreness of arm after first dose of COVID-19 vaccine. The outcome for other events was not recovered. The patient stated that she will receive her second epidural injection on 02Feb2021 but also reported that her second COVID-19 vaccine shot is scheduled for 11Feb2021. The patient inquired if there is any study, or danger in having the epidural shot and Covid shot close together or if she needs to space them apart. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1010821
Sex: F
Age:
State: OH

Vax Date: 01/08/2021
Onset Date: 01/10/2021
Rec V Date: 02/08/2021
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: She had a positive covid test on 16Jan2021. Symptoms on 10Jan2021; She had a positive covid test on 16Jan2021. Symptoms on 10Jan2021; headache; Fatigue; This is a spontaneous report from a contactable Other HCP. A 48-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date unknown) via Intramuscular on 08Jan2021 12:00 PM (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EK5730 and Expiration Date unknown) via Intramuscular on 19Dec2020 11:15 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation and first dose of measles vaccine, mumps vaccine, rubella vaccine (MMR) booster for immunisation. The patient's medical history was included allergies to nubain and CT dye, chronic sinus issues. The concomitant vaccine included second dose of measles vaccine, mumps vaccine, rubella vaccine (MMR) booster on 23Nov2020 for immunisation. Patient had symptoms of increase headache and fatigue on 10Jan2021. Patient had a positive covid test on 16Jan2021. The outcome of events was not recovered and without treatment received.; Sender's Comments: Based on the available information, causality between events Drug ineffective / COVID-19 virus test positive and BNT162B2 vaccine cannot be completely excluded.

Other Meds:

Current Illness:

ID: 1010822
Sex: F
Age:
State: TX

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/08/2021
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: Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1010823
Sex: F
Age:
State: MI

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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: allergic reaction to the product/ throat was swelling and started to close up/ hives and itching/ blood pressure dropped and heart rate increased/ chest tightness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old-female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL3248), via an unspecified route of administration into left deltoid on 21Jan2021 10:20 at a single dose for covid-19 immunization. The patient was allergies to sulfa medications and latex and she had the flu vaccine in Nov2020. The patient concomitant medications were none. The patient called to report on the COVID 19 vaccine and she had an allergic reaction to the product. The patient explained that she got the vaccine yesterday at around 10:20 am and was in the emergency room at 10:48 am. Her throat was swelling and started to close up and this has resolved after medication. She had hives and itching which are now ongoing and about the same, her blood pressure dropped and there was an increased in her heart rate which have both gotten better, and she had chest tightness which is about the same. She received IV Benadryl, Solumedrol, and Pepcid. The patient was treated and released from the emergency room. No investigation assessment. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1010824
Sex: F
Age:
State: FL

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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; scratchy throat; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 15Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included blood pressure high, thyroid disorder and mental health disorder. Concomitant medication included took one medication for high blood pressure and a thyroid medication, both of those have been diagnosed quite a while and she had been on those medications a while. Patient was also on a mental health medication as well. Patient had a headache Tuesday (19Jan2021) or Wednesday (20Jan2021) this week. Patient also had a really scratchy throat. She didn't know if that was related to bnt162b2 or not. Treatment included ibuprofen (ADVIL 200mg, lot: R88356, expiration date: May2023). Patient took two 200mg, no more than every 4 hours or something, then clarified that patient took a couple at nighttime. Headache hadn't gotten worse. It was not as bad today (22Jan2021). It seemed to be subsiding. Outcome of headache was resolving. Outcome of scratchy throat was unknown.

Other Meds:

Current Illness:

ID: 1010825
Sex: M
Age:
State: NY

Vax Date: 12/18/2020
Onset Date: 12/22/2020
Rec V Date: 02/08/2021
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: there is a risk of being exposed for Covid; General malaise; muscle aches and pain; This is a spontaneous report from two contactable consumers A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), intramuscular in the right deltoid on 18Dec2020 07:15 at a single dose to prevent covid. Medical history included hypertension, stage 3 renal failure and his creatinine level was elevated ( and now it was under control since he was not taking nsaids and changed his medications around; he cannot take nsaids; and his creatinine was 1.6 and now it was 1.27 (dates unspecified)). Concomitant medication included unspecified medication for hypertension. Patient had no prior vaccinations (within 4 weeks) aside from first dose of covid vaccine. He got the local flu shot a few months ago as it was required by his employer. He received the mmr v vaccine about 4.5 years ago and he had a terrible reaction for a week: he had muscle aches, pain and joint pain and everything hurts and it eventually went away. He does not have the exact name, lot, ndc, or expiration date to provide. It is on record at his employer. On day 4, 22Dec2020, after the first dose of the vaccine he had generalized malaise, muscle aches and pain, it was painful to put a pair of socks on and it went away within 24 hours. He sees covid patients everyday at the hospital. He does echocardiography and he is close to the patients for 20 minutes and there is a risk of being exposed for Covid. He clarified he is a registered diagnostic licensed medical sonographer, not a hcp. The outcome of the events general malaise and muscle aches and pain was recovered on 23Dec2020. Information on the Lot/Batch number has been requested

Other Meds:

Current Illness:

ID: 1010826
Sex: M
Age:
State: NY

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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: fever; vomiting; This is a spontaneous report from a contactable consumer. This consumer reported for a (age group: adult) male patient received 2nd dose of BNT162B2 on 20Jan2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Historical Vaccine was 1st dose of BNT162B2 in Jan2021, had soreness in his arm. He had a fever and is vomiting from 21Jan2021 with outcome was not recovered. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021061327 Same reporter/patient, same vaccine in different dose, different events

Other Meds:

Current Illness:

ID: 1010827
Sex: F
Age:
State: WV

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: temperature of 100.5, a little high; Headache; She took a nap and around 4pm, she woke up and didn't feel good; Nausea; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3248) on 21Jan2021 around 09:30 AM, in right upper arm, for COVID-19 immunization. No other vaccine was given on the same day or within 4 weeks prior. Medical history included gastric sleeve surgery on 05Jan2021. Concomitant medication included ondansetron hydrochloride (ZOFRAN) for nausea. The patient took a nap and around 16:00 on 22Jan2021 she woke up and didn't feel good and had nausea. On 22Jan2021 at 16:40 the patient experienced also temperature of 100.5, a little high and realized she had a headache. However, she also just had a gastric sleeve surgery on 05Jan2021 and she had been experiencing nauseas from some days, so she was not sure if what she was experiencing had anything to do with that or with the COVID-19 shot because she had not nausea every day. She did take a Zofran. The events did not require a physician office or ER visit. Relevant tests: none. Events outcome was unknown.

Other Meds: ZOFRAN [ONDANSETRON HYDROCHLORIDE]

Current Illness:

ID: 1010828
Sex: M
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 02/08/2021
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: fever of 103.3 Fahrenheit; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a fever of 103.3 Fahrenheit on an unspecified date with outcome of unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1010829
Sex: F
Age:
State: WV

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 02/08/2021
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: pain in her knees that went down to her feet; pain in her legs/ went down to her feet; maybe it was arthritis; can't hardly walk; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1284 and Expiration Date unknown) via an unspecified route of administration on 09Jan2021 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was reported as none.On Monday (11Jan2021) morning she had a lot of pain in her legs and knees that went down to her feet. She thought maybe it was arthritis, but it was still there and it still hurts. She can't hardly walk real good cause it hurts. She was wondering if it could be a side effect from that vaccine. She wanted to know if there been a reaction like this in other people. Supposed to get her second dose on 30Jan2021. The outcome of events was not recovered without treatment involved. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1010830
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: Body aches; Tiredness; Slight headache; This is a spontaneous report from a Non-contactable Other-HCP reported for self. This 23-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 16:30 PM on Arm left at single dose for covid-19 immunisation. Medical history included GERD, Barrett's esophagus. No Known allergies. No covid prior vaccination. Concomitant medications included omeprazole for Birth control, hydroxyzine for Birth control, sertraline for birth control. She experienced Body aches, tiredness, slight headache on 22Jan2021. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: OMEPRAZOLE; HYDROXYZINE; SERTRALINE

Current Illness:

ID: 1010831
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/20/2021
Rec V Date: 02/08/2021
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: patient received both doses of COVID-19 vaccines and tested positive for COVID-19; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EH9899/expiration date: unknown), via unknown route of administration, on 22Dec2020 13:00 PM (at the age of 43 years old) as a single dose on right arm and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: unknown), via unknown route of administration, on 11Jan2021 09:30 AM (at the age of 43 years old) as a single dose on left arm, for COVID-19 immunisation at a hospital. Relevant medical history included exposure to COVID-19 on 15Jan2021 because her oldest son tested COVID positive on Tuesday with a rapid COVID test and she had dinner with her son on Friday (15Jan2021). Historical vaccine included flu shot in Oct2020. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received both doses of COVID-19 vaccines and tested positive for COVID-19 via COVID PCR test on 20Jan2021. The patient reported that she was asymptomatic and was at home quarantining. The patient would like inquire for information on volunteering in any post-vaccination research trials as she would be a candidate for it. Laboratory test included COVID PCR (polymerase chain reaction) test on 20Jan2021 with positive result. The outcome of the events "patient received both doses of COVID-19 vaccines and tested positive for COVID-19 via COVID PCR test" was unknown. It was also reported that the sample of product was not available to be returned.

Other Meds:

Current Illness:

ID: 1010832
Sex: M
Age:
State: CA

Vax Date: 01/19/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: he noticed there was a total absence of discomfort of his normal pain that he was in, in his leg, and back, and with his joint issues; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK4176) intramuscularly in left arm on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient states that this would seem a little unusual, because he was not calling to tell Pfizer about an adverse reaction, but rather, a positive reaction to a product. Patient stated that this was extremely odd, and he had not heard this before, so Pfizer might be interested to know, that the patient received his COVID 19 Vaccine at his VA office on 19Jan2021, and within 24 hours, he noticed there was a total absence of discomfort of his normal pain that he was in, in his leg, and back, and with his joint issues (also reported as within 24 hours that his normal pain and discomfort were relieved). Patient stated that the product acted as an anti-inflammatory for him. Patient stated that this side effect was still ongoing at this time, but that it was starting to wane. Patient stated that he did not take any anti-inflammatories, no Advil, no Tylenol, so this was a totally raw experience. Patient received no other vaccines on the same day. Patient stated that he did not know if this was relevant, but he had blood type O Negative. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1010833
Sex: F
Age:
State: NC

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: She noticed on her chest and all around her neck is broken out in rash; she has welts on chest; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 11:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient noticed on her chest and all around her neck was broken out in rash and she had weltes on chest on 22Jan2021. Should she go to the emergency room? The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1010834
Sex: F
Age:
State: FL

Vax Date: 01/13/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: cellulitis from the shot in left arm; This is a spontaneous report from a contactable consumer reported for herself. This 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 in her left arm at single dose for covid-19 immunisation. Medical history and concomitant medications were none. There were no additional vaccines administered on same date of BNT162B2. The patient previously received a pneumococcal vaccine (reported as pneumonia shot) on unspecified date for immunisation where kind of the same thing happened, she had red, bumped up and itchiness at the injection. she didn't remember if she was diagnosed with cellulitis as it was a long time ago and she has no NDC, Lot, or Expiry for the product. The patient experienced cellulitis from the shot in left arm on 22Jan2021. The event did not require a visit to Emergency Room. She just called the doctor and was given a prescription, the name of the prescription was unknown. The outcome of event was not recovered. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1010835
Sex: F
Age:
State: NJ

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: Loss of taste; This is a spontaneous report from a contactable pharmacist (patient). A 47-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 21Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were none. No known allergies. There is no other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. The patient previously took the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 31Dec2020 14:30 at a single dose for covid-19 immunization. The patient experienced Loss of taste on 22Jan2021. There is no treatment received for event loss of taste and no covid test post vaccination. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1010836
Sex: M
Age:
State: NC

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: Chest pressure sensation; also accompanied with slight burning sensation/chest sensation as internal; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EL1283; expiry date: 30Apr2021) via an unspecified route of administration on 22Jan2021 about 10:57 AM at left arm at a single dose for COVID-19 immunization. Patient History and other products were reported as no. The patient experienced chest pressure sensation on 22Jan2021 with outcome of resolving. The details was as follows: the patient got the vaccine today (on 22Jan2021) about 10:57AM. When getting the vaccine they made his go through stalls, it was multiple cars on each side, what stood out to him was, when his vehicle moved up, he was the driver in this case, and so the vaccination was on his left arm, when the gentlemen went to insert the needle, he expected it to be a green needle attached, but the color of the syringe was black with a black band. He noticed the car before had a green attachment for their needle and the syringe, it was Green and clear looking but his was black. He asks if the color of the needle is suppose to be a certain color. Caller was informed that he may need to contact the facility from where he received the vaccine for this clarification. He also adds that he was okay for the 15 minutes, but then he left feeling a little sensation in the chest that he did not have before, it was not superficial on the skin it was internal in his chest. He was naturally calling to see, what he could find out, are there multiple colors for the needles or were they standard, green or clear plastic. He also would like to know if Pfizer directs the administration of the product to be drawn up in front of the client. The chest sensation started about 1:30 or 2 o clock PM the same day, he described the chest sensation as internal, in the center of the chest, sort of like a pressure downward, also accompanied with slight burning sensation, something that was different that he had never usually felt. He also asks if there was a certain protocol or standard the folks administering the vaccine were suppose to follow. The outcome of event was reported as the chest sensation has dissipated a little in terms of intensity, but he felt as if it was trying to be dormant in that area.

Other Meds:

Current Illness:

ID: 1010837
Sex: F
Age:
State: VA

Vax Date: 01/13/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: injection site red and hurting; injection site red and hurting; It is still swollen, red, with a big red circle/size of 2 half dollars; hot to touch; Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age receive the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Caller reports getting the first Covid vaccine on 13Jan2021 and is due for the second one on 03Feb2021. Having the first dose, after 8-9 days, in Jan2021 she is having some reaction to it. It's almost been 10 days. Had a reaction in beginning at the injection site, it was red and hurting and you can tell just by touching it. It is still swollen, red, with a big red circle, is hot to touch, and the size of 2 half dollars and this concerns her. Has had tiredness, headaches, and muscle pains. Thought the swelling would be gone by now, has been using cool compresses. She can deal with the other things, but wants to know why is the swelling and redness lasting so long. It's not hurting her, but it is worrisome. The area has gone down and it's not hot to touch. Has not had any fever. Has taken all safety precautions and does not feel like she has contracted Covid from anyone other than injection in 2021. The outcome of event Vaccination site erythema, Vaccination site swelling was not recovered; outcome of event Vaccination site warmth was recovered on 22Jan2021; outcome of other events was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1010838
Sex: F
Age:
State: NY

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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: itchy on face and other parts of body; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3247, expiration date: 31May2021), via unspecified route of administration on right arm on 21Jan2021 at 13:30PM at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient mentioned she didn't have any of the side effects they mentioned on the paper. Stated about two hours later she started to feel itchy on her face and then it became itchy on other parts of her body including her back. Added she had no rash or welts. This continued to midnight. Added she woke up about a quarter to twelve and then fell back to sleep so she thought it was better. She still felt slightly itchy this morning, so she took Zyrtec this morning at 08:00AM and now she felt perfectly fine. Mentioned she would have taken the Zyrtec last night but she took Amitriptyline 10mg at night and didn't want to take them together. She was scheduled for the second dose of the vaccine on 11Feb2021. None of adverse events required a visit to physician or ER. None prior vaccinations within 4 weeks. The outcome of the event was recovered on 22Jan2021.

Other Meds:

Current Illness:

ID: 1010839
Sex: F
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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: Fever 102.0; chills; vomiting; body aches; headache; This is a spontaneous report from a contactable nurse (patient). This 37-year-old female nurse (pregnant: No) received 2nd dose of BNT162B2 (lot number=El3249) intramuscular on 20Jan2021 01:45 AM at single dose on Left arm for covid-19 immunization. No other vaccine in four weeks. Concomitant drug was Amoxicillin. Historical Vaccine was first dose of BNT162B2 on 30Dec2020. Patient experienced Fever 102.0, chills, vomiting, body aches, headache on 21Jan2021 06:00 AM with outcome was recovered. No treatment. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds: AMOXICILLIN

Current Illness:

ID: 1010840
Sex: F
Age:
State: NC

Vax Date: 01/21/2021
Onset Date: 01/23/2021
Rec V Date: 02/08/2021
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: Diarrhea; stomach cramping; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 12:00 PM at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at vaccination was 35 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included hypothyroid, known allergy to milk and latex, and COVID-19 on an unspecified date. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM), escitalopram oxalate (LEXAPRO), montelukast sodium (SINGULAIR). On 23Jan2021 at 12:00 pm, the patient experienced diarrhea, stomach cramping, nausea, fatigue. No treatment was given for the events. The events were resolving. The patient was not tested for COVID-19 post vaccination. No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.

Other Meds: LEVOTHYROXINE SODIUM; LEXAPRO; SINGULAIR

Current Illness:

ID: 1010841
Sex: F
Age:
State: PA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/08/2021
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: 1st dose- 06Jan2021/ her 2nd dose received on 20Jan2021; wiped out/ tired; headache; had no energy; Rigors; fever of 102.6; This is a spontaneous report from a contactable nurse (patient). This 55-year-old female patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 at 8:45AM via an unknown route at right arm for Covid-19 immunization. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Medica history and concomitant drug were reported as "none". Patient previously had 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 in right arm (Lot/NDC/Expiry unknown). No other vaccinations within four weeks prior to the first administration date of the suspect vaccine; no adverse events following prior vaccinations. No family medical history relevant to adverse event. The patient reported some side effects from her 2nd dose received on 20Jan2021 at 8:45AM. She had a fever of 102.6 which started at 8pm on 20Jan2021 and broke this morning at 6am. The patient stated that the fever was gone, but she wouldn't say she has recovered completely because she still feels wiped out; had headache and was tired; also stated that she was not able to eat, and had no energy while she had the fever. The rigors started at 9pm on Wednesday, 20Jan2021. She stated that she couldn't do anything for the few hours it lasted. No other relevant diagnostic and confirmatory test results for events. No investigation assessment performed. The event did not require a visit to Emergency room or Physician office. The reported considered seriousness for fever was medically significant, for rigors was disabling. Outcome of fever was resolving. Outcome of rigors was resolved on 21Jan2021. Outcome of the other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia and chills cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1010842
Sex: F
Age:
State: MT

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/08/2021
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: feeling icky all day; Rash on front and back of nect; chest, and little bit down both arms; Muscle aches; This is a spontaneous report from a contactable consumer(patient).A 74-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3246), via an unspecified route of administration on 12Jan2021 16:45 at single dose, left upper arm for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient had a little bit of muscle aches on 12Jan2021 after the vaccine kind of all day. Other days it came and went. On 19Jan2021 the patient felt icky all day. She got a rash on the front and back of her neck. Rash was also on her chest and a little bit down both arms. She went to a walk-in clinic. Wasn't sure if it would be related to the COVID-19 Vaccine, but was advised to report it. Events required a visit to walk-in clinic. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1010843
Sex: F
Age:
State: VA

Vax Date: 01/03/2021
Onset Date: 01/03/2021
Rec V Date: 02/08/2021
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: She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to touch. She was sensitive all over.; Chest burning and hurting; Joint pain; extremely dizzy; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; arm was sore/soreness where they gave the vaccine on her arm all the sudden came back very suddenly; The lady that gave it was not gentle. She screamed.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL1284) via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient had headaches in the past. The patient's concomitant medications were none. The patient got vaccine on the 03Jan2021 and her arm was sore, but she felt like this was normal, just like it would feel after a flu shot. Throughout the next week, she was extremely stressed for work. By Friday, which would have been 6 days later. She was feeling really off wellness wise. She was very fatigued, and extremely dizzy on 07Jan2021. On Saturday night 09Jan2021, she felt very bad. She had a sore throat, she was coughing, her chest was burning and hurting. She had severe chills and aches. She thought maybe she needed more sleep because she works out 6 days a week. She felt like she was in over drive like she was killing herself. Sunday morning 10Jan2021, she felt bad. She has so much adrenaline. She was always on the go. She decided to take a nap before the gym Sunday, and she woke up with a huge migraine. She had headaches in the past, but never a migraine. Her head was hurting so bad it woke her up. It hurt all over. She also felt like she had taken a hammer to her joints and bones. Her joints and bones were hurting. She has never felt that before. Her muscles were so achy. Her skin even hurt to touch. She was sensitive all over. She had severe chills. The soreness where they gave the vaccine on her arm all the sudden came back very suddenly. It came back the same day as the other symptoms started. They mostly started on the 09Jan2021, and then on the 10Jan2021 they were worse while migraine and bone hurting were occurred on 10Jan2021. She assumed there were subtle symptoms leading up to the 09Jan2021, but she just didn't realize it. That was a Saturday and Sunday. The lady that gave it was not gentle. She screamed. The side effects lasted at least 5 days after the 10Jan2021. On the 10Jan2021, she did not feel well so she got tested for COVID because her boss told her to. They tested her Flu, COVID, and strep. She only tested positive for COVID on 10Jan2021. She felt like she wouldn't be able to drive. She couldn't walk for 4 days. She felt most of the symptoms had gone away around 5 days after the 10th except fatigue, feeling dizzy, and headaches here and there. She also had a little coughing here and there. That started 09Jan2021 and was ongoing but improved. She got the vaccine because the doctor at her practice really encouraged her to get it done. She also thought if she ever wanted to travel that she might need it. She thought in the long run she might benefit from having the vaccine. She felt peer pressured honestly to get it because she was sketched out to get it at all. She wants to know the rate of people testing positive for COVID after getting the vaccine. The outcome of the events sore arm, chest burning, joint and bone pain, skin even hurt to touch and sensitive was recovered on 15Jan2021, the outcome of the events screamed and couldn't walk was unknown and the outcome of the other events was recovering.

Other Meds:

Current Illness:

ID: 1010844
Sex: F
Age:
State: PA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/08/2021
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: Low grade temp 99.1; diarrhea; body aches; chills; migraine; sweats; severe fatigue; Dose Number 1, Date of start of drug 21Dec2020/ Dose Number 2, Date of start of drug 20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 20Jan2021 07:30 at left arm, at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included isotretinoin (ACCUTANE), cetirizine. The patient previously took pediazole and experienced Known allergies: pediazole. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 21Dec2020 09:15, at Left arm, at single dose for covid-19 immunization. The patient experienced low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue at 20Jan2021 12:00. No treatment was received for events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue. The outcome of the events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.

Other Meds: ACCUTANE; CETIRIZINE

Current Illness:

ID: 1010845
Sex: F
Age:
State: TX

Vax Date: 01/20/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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: soreness in right arm; numbness in right hand; tingling in right foot; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EL9262), via an unspecified route of administration in the right upper arm on 20Jan2021 at single dose for covid-19 immunisation. The patient medical history included ongoing diabetes. Concomitant medications were not reported. The patient experienced soreness in right arm, numbness in right hand and tingling in right foot on 22Jan2021 with outcome of not recovered. She was schedule for the second dose on 10Feb2021.

Other Meds:

Current Illness: Diabetes

ID: 1010846
Sex: F
Age:
State: SD

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/08/2021
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: could not get her head around what day it was/ her brain was not working right; disoriented/disorientation; body not responding/she couldn't function; This is a spontaneous report from a contactable Other Health Professional (patient). An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 by injection once to right deltoid (Batch/lot number: EL0142), second dose of BNT162B2 via an unspecified route of administration on 18Jan2021, both at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Investigation Assessment: No. The patient had second her COVID shot, the vaccine, on 18Jan2021, and she is a very healthy 84 years old with no health problems, and she woke up on 19Jan2021, and was disoriented, she could not get her head around what day it was, this was so rare, she normally goes to the fitness center and excursuses, but her body was not responding, her brain was not working right, it was a strange ordeal, so she got in the shower, to get her circulation going, and she couldn't shower, she got all wet, and had to get out and lay on a towel, she couldn't function, it was very scary, and very atypical. Her disorientation went away by 10AM on 19Jan2021- she did not see anyone or go to a provider. Her body started not responding around 7:30 when she got up, and by 9 or 10AM, she was functioning again. The patient didn't think this was from vaccine, she had seen enough vaccine reactions to various vaccines, and this was not a vaccine reaction, she thought what is happening? Is this a stroke, or a vascular event, she has since recovered but was still very shook, anxious about what it was, what happened until an hour or so after, it was still under her. Causality: Unknown, she didn't think of the connection until someone else did, she was describing it and the other person said it was because of the vaccine, as this person was a skeptic and doesn't want the vaccine herself, and this was not a typical response, but then she got to thinking. The outcome of disoriented/disorientation and body not responding/she couldn't function was recovered on 19Jan2021, the other event was unknown. Seriousness: it was disabling at the time, she was concerned she had a stroke, she was checking her grasps and her face and legs, she was obsessing. Seriousness for disoriented/disorientation and body not responding/she couldn't function was disability. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of serious events cannot be excluded, considering the plausible temporal relationship. The underlying medical conditions in the advanced old patient considered confounders. 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: 1010847
Sex: M
Age:
State: NC

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. 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: 1010848
Sex: F
Age:
State: CA

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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: sore arm; This is a spontaneous report from a contactable consumer reported for herself. A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route at the left arm on 01Jan2021 at single dose and the second dose via unspecified route at the right arm on 21Jan2021 around 10am at single dose, for COVID-19 immunization. Medical history included depression. The patient is not pregnant. The patient had no covid prior vaccination and no known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and birth control for awhile. On 01Jan2021 the patient experienced sore arm. The event was assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the event was unknown Information on the lot/batch number has been requested

Other Meds: WELLBUTRIN

Current Illness:

ID: 1010849
Sex: F
Age:
State: CA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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: sore arm; cannot sleep at all; chills; body aches; a bit of a hard time breathing; restless; feeling warm/heat; nauseous; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm, via an unspecified route of administration on 21Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included depression. The patient had no covid prior vaccination and no known allergies. Historical Vaccine included first dose of bnt162b2 taken on 01Jan2021 (Vaccine location: Left arm) for covid-19 immunisation and the patient experienced sore arm. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), and birth control for awhile. The first dose the patient just had a sore arm, the second dose which she took yesterday 21Jan2021 around 10:00 caused a much more sore arm than the first dose she felt this after 2-3 hours of 2nd dose of vaccine, tonight she cannot sleep at all Jan. From 21Jan2021 to 22Jan2021 she keep waking up every 2 hours with chills body aches very sore arm a bit of a hard time breathing feeling very restless and not able to sleep, feeling warm/heat as well and a bit nauseous. The adverse events started on 21Jan2021 13:00. The patient received no treatment for the adverse events. The patient had no covid tested post vaccination. The outcome of events was not recovered. Information on the lot/batch number has been requested.

Other Meds: WELLBUTRIN

Current Illness:

ID: 1010850
Sex: F
Age:
State: WI

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/08/2021
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: dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; chilled; in particular hands were very cold; pale color; slurred speech; mental fog; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3249), via an unspecified route of administration at site of right arm on 20Jan2021 09:30 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin D3 and iron (SLOW RELEASE IRON) and daily multivitamin. Within minutes of receiving the dose on 20Jan2021 at 09:45 AM, dizziness, increased heart rate, increased blood pressure, flushed, weakness, and shakiness. About an hour after receiving the dose on 20Jan2021, lethargy, chilled, in particular hands were very cold, pale color, mental fog, and slurred speech. The patient did not receive any treatment from events. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported temporary mental fog/mental impairment was likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Other Meds: VITAMIN D3; SLOW RELEASE IRON

Current Illness:

ID: 1010851
Sex: M
Age:
State:

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 02/08/2021
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: Vertigo; 101 F oral temperature; nausea; generalized weakness; rigors/ chills; generalized muscle aches; This is a spontaneous report from a non-contactable Nurse (patient). A 27 years old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 27 years old on 21Jan2021 09:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Vertigo, 101 F oral temperature, nausea, generalized weakness, chills, rigors, generalized muscle aches. Patient did not have covid prior vaccination and did not have covid tested post vaccination. The outcomes of events were unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1010852
Sex: M
Age:
State: TN

Vax Date: 01/19/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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: COPD is a whole lot better; COPD is a whole lot better; This is a spontaneous report from a contactable consumer reporting for himself and from another consumer. An 80-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration in left arm, on 19Jan2021 at 11:30, at single dose, for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (from 10 to 15 years), ongoing diabetes mellitus (from 10 to 15 years), ongoing cardiac disorder, ongoing bone disorder, ongoing body height decreased (due to natural aging). Concomitant medications included lisinopril (unknown manufacturer, 20 mg) from 10/15 years and ongoing for cardiac disorder, calcium, colecalciferol (CALCIUM + VITAMIN D3, 400IU/600mg) from 2020 (from 1 year) and ongoing for bone disorder and to help immunisation. The patient reported that COPD was a whole lot better on 21Jan2021 at 10:30. He had no popping in the lungs and his lungs were clear.

Other Meds: LISINOPRIL; CALCIUM + VITAMIN D3

Current Illness: Body height decreased (Due to natural aging); Bone disorder; COPD (from 10 to 15 years); Diabetes (from 10 to 15 years); Heart disorder

ID: 1010853
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
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 pain in her right ear cartilage; This is a spontaneous report from a contactable consumer(the patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246, expiration date Apr2021), via an unknown route of administration, on 19Jan2021 at 13:45 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was reported as "none." The patient was administered the vaccine in a clinic. The patient's concomitant medications were not reported. The patient had not received any other vaccines within four weeks prior to the vaccination. On 21Jan2021 at 16:30 the patient experienced severe pain in her right ear cartilage which she stated hurt unbelievably. The patient took an aspirin and Benadryl and went to bed, but the pain woke her up about every fifteen minutes throughout the night. She stated that as of the reporting date it was eighty percent better. The clinical outcomes of pain in ear was reported as recovering.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm