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: 1022071
Sex: M
Age:
State: FL

Vax Date: 01/24/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
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: hearing is off/his ears feel like they're full of water so he can't really hear; lost his voice; dizziness/Really dizzy; bottom of the feet is tingling; Slightly blurry vision; This is a spontaneous report from a contactable consumer (caregiver). An 82-years-old male patient (Father) received first dose of BNT162B2 (BNT162B2, lot number: EL1283), via an unspecified route of administration in left arm on 24Jan2021 13:30 at SINGLE DOSE as Scared to death to get COVID. Medical history included ongoing High blood pressure. Family history included Father died of melanoma. Concomitant medication included ongoing lisinopril (strength: 10mg) for High blood pressure. Caller stated her father received the pfizer covid vaccine first dose on this Monday and have weird side effects, he lost his voice, dizziness/ Really dizzy, hearing is off/ Ears feel like they're full of water so he can't really hear, bottom of the feet is tingling/ tingling in his feet and slightly blurry vision. Caller wanted to know if it is normal. Caller also said safety department told her to speak to quality department about the shot her farther received is it a bad batch or not. No visit to Emergency Room and Physician Office. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.

Other Meds: LISINOPRIL

Current Illness: Blood pressure high

ID: 1022072
Sex: F
Age:
State: FL

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 02/11/2021
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: She felt like she was passing out; Dizziness; Felt tingling of her tongue; Blood pressure was rising; She had tongue itching; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. This 73-year-old female consumer reported that she received 1st dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine; lot number FL1284) on 10Jan2021 1:00pm at left arm for COVID-19 immunization. Medical history included allergic to latex. Concomitant drugs included Atenolol for Blood pressure high from 2011, Furosemide from 2011 as Diuretic, Alprazolam from 2011 for Sleeping and anxiety, Simvastatin from 2011, all were ongoing. The patient experienced a reaction after the first dose on 10Jan2021 that she became dizzy and felt tingling of her tongue. Every 15 minutes they checked her blood pressure for an hour. Her blood pressure was going up slightly. She was monitored by fire rescue and her blood pressure was rising but not dangerously high. The fire rescue also checked her blood sugar (normal result) and other lab values and decided she did not need emergency room care and instructed her to take Benadryl when she got home. They felt she had a mild reaction. The patient stated the dizziness came in waves and she felt as if she was going to faint. The dizziness went in waves where she felt like she was passing out. The tingling on her tongue felt similar to the allergic reactions she has had in the past to latex but without swelling. She did not have tongue swelling. She had tongue itching. It was like having a reaction to the latex gloves when you go to the dentist. Her symptoms only lasted for two hours. After a total of 2.5 hours she had no symptoms. Dizziness, tingling, and elevated blood pressure initially that went away after taking Benadryl. She was scheduled to receive second dose on 31Jan2021. The events was resolved on 10Jan2021.

Other Meds: ATENOLOL; FUROSEMIDE; ALPRAZOLAM; SIMVASTATIN

Current Illness:

ID: 1022073
Sex: F
Age:
State: GA

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
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: Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left facial swelling; facial abscess; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 57-Year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date in Jan2021 for Covid-19 immunization. Medical history included hypertension diagnosed for years as of 27Jan2021, and dental cleaning (also reported unsure if it was after or before vaccine). Concomitant drug was reported as "none". She not sure of the exact date of administration, stated patient came in to the office to be seen on Friday morning, 22Jan2021. Patient told caller at that time that she had the vaccine last week as of 27Jan2021, was seen for severe left facial swelling, onset of symptom was on Wednesday 20Jan2021. She was treated for facial abscess with Clindamycin 300mg 4 x a day for 10 days, she took first dose of treatment on Friday 22Jan2021. She followed up with doctor on 27Jan2021 and was improved, about 75%better. Her Blood pressure was also a little elevated on 22Jan2021 visit, it was 196/106 and on 27Jan2021 it was 179/101, did not know if this related to vaccine or symptoms. Patient reported that she went to dentist and had cleaning, unknown exact date of cleaning, unsure if it was after or before vaccine. She stated that doctor thought the symptoms could be due to dental cleaning not the vaccine. Patient went to ENT on Monday 25Jan2021 and they cleared her of anything ENT related from her neck up; scoped her and looked at her sinuses, and everything was fine. The ENT doctors told the patient that it appeared to be a reaction to the vaccine and advised her not to get the second dose. The reporter inquired whether patient should get the second dose. No Investigation Assessment was performed. The event severe left facial swelling was reported as serious with seriousness criteria of other medically important condition. Outcome of the event severe left facial swelling and facial abscess was resolving. Outcome of the other event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the outcome of treatment, the reported events severe left facial swelling, facial abscess, and elevated BP are likely intercurrent medical conditions and are unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1022075
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: third migraine in 5 days after receiving second covid vaccination; nausea; This is a spontaneous report received from a contactable consumer and based on the information received by Pfizer from (Reference ID: Not provided). A male patient in his early 40's received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving the second "COVID vaccination", the patient experienced the third migraine in 5 days and nausea. The patient received ubrogepant (UBRELVY) to treat migraine. The events onset date and outcome were unknown at the time of the report. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022076
Sex: M
Age:
State:

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
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: unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. 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: 1022077
Sex: F
Age:
State: MI

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
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: headache; Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine.; could be sinuses; Dizziness; Sweating; lymph nodes swollen; she tends to get hot flashes, she is currently going through menopause; This is a spontaneous report from a contactable consumer, the patient. A 48 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EL3248 ), intramuscular in the left arm on 15Jan2021 at 06:34 as a single dose, for COVID-19 immunization. The vaccination was administered at a Hospital Facility. Patient contact her doctor who told her, she absolutely needed the COVID-19 vaccine. Medical history included ovarian cancer 2014 (stage 3B and 3C), lymphoedema 2015, (lymphedema after aggressive chemo/ told she would always have lymphedema), and menopause from an unknown date and ongoing (tends to get hot flashes). There were no concomitant medications. On 15Jan2021 (around noon), the patient experienced Lymph nodes swollen/her lymph nodes in her throat were swelling up, dizziness, and sweating. Patient explains she tends to get hot flashes, she is currently going through menopause. However, she ran to the store and she was really sweating heavily and felt dizziness and just ended up going home. She felt it was better to be at home if she was having a reaction. By Saturday, 16Jan2021, she woke up and felt fine. The swelling of her lymph nodes in her throat went away. The dizziness and sweating went away. On 19Jan2021 (Tuesday Evening) the patient experienced Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine. Also states it could be sinuses. She didn't know if this could be related to the COVID-19 vaccine and a reaction to it or her sinuses. On Jan2021 patient experienced Hot flashes. No other vaccines were given within 4 weeks. The clinical outcome of Dizziness, Sweating was recovered on 16Jan2021, the outcome of Headache/migraine was not recovered, and the outcome of lymph nodes swollen, hot flashes and sinuses were unknown.

Other Meds:

Current Illness: Menopause (tends to get hot flashes. Currently going through menopause)

ID: 1022078
Sex: F
Age: 43
State: PA

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/11/2021
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: Penicillin

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: ?Moderna COVID?19 Vaccine EUA Fever, chills, extreme headache, every single joint throbbing Dizziness

Other Meds: None

Current Illness: None

ID: 1022079
Sex: F
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
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: chest congestion; consisting of headache; sore throat; fever; shortness of breath; diarrhea; facial pain; burning sinuses; now she was weak; This is a spontaneous report based on the information received by Pfizer from Allergan (Manufacturer Report Number: AGN255108). A contactable consumer reported that a 6-decade-old female patient (not pregnant)received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took Botox for 8-10 years for Cervical Dystonia and in the beginning she had torticollis. The Botox straightened out her torticollis, which caused unspecified allergies for which she took Allegra-D. Her last Botox treatment was in Oct2020. She was past due for Botox due to having to take the Covid-19 vaccine. The patient got a Covid-19 vaccine on 20Jan2021. On 21Jan2021 she began having a "reaction" to the vaccine, consisting of headache, sore throat, fever, chest congestion, shortness of breath, diarrhea, facial pain, and burning sinuses. It took 24 hours after the vaccine to show symptoms, events began 21Jan2021. The symptoms were ongoing and now she was weak, and was unsure how long she will be at work today. There had been no treatment for the symptoms. The outcome of the events were not resolved. Information on lot number/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022080
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: slight fever; headache; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced slight fever, headache, soreness in arm. The outcome of the events was unkown. Information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1022081
Sex: F
Age: 66
State: FL

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/11/2021
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: none

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Patient stated she started feeling tingling on her forehead and seconds after it went away but she started to feel numbness on the top of her mouth. No allergies reported. No medications were administered, patient stated she is feeling better 15 minutes after. Patient refused to go to the hospital, she said she is doing better and wants to go home.

Other Meds: Statins

Current Illness: high cholesterol

ID: 1022082
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: between the time she was covid positive; between the time she was covid positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number not known) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient said she got her first dose and between the time she was covid positive she said that she is scheduled to have the second dose this Thursday the 28Jan. Caller was asking if she could get the second dose even though she is a covid positive she said that she will be out of quarantine today (26Jan2021). The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022083
Sex: M
Age:
State: OR

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 02/11/2021
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: evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; This is a spontaneous report from a contactable physician. A 62-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation. Medical history included diabetes and graft was 2.5 years old, partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. Concomitant medication included trazodone, rosuvastatin calcium (CRESTOR), zolpidem tartrate (AMBIEN), gabapentin, metformin. No COVID prior vaccination. Known allergies: Buspar. The patient previously received first dose of bnt162b2 on 28Dec2020 for COVID-19 immunization and experienced Cornea transplant rejection and inflammation/subepithelial infilatrates noted 1 week after the first vaccine. No other vaccine in four weeks. The patient experienced after 2nd vaccine, evidence of endothelial inflammation and anterior chamber cells and KP on endothelium. Clinical course reported as: Cornea transplant rejection. Graft was 2.5 years old. Partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. Signs of inflammation noted one week after each vaccine. Subepithelial infilatrates noted 1 week after the first vaccine. Resolved with Pred Forte. However, after 2nd vaccine, evidence of endothelial inflammation and anterior chamber cells and KP on endothelium noted on follow-up examination. Placed on stronger topical steroid with Durezol. Patient asymptomatic during entire process and this was found on routine follow-up exam and not because patient noted any symptoms. Vision not affected. Outcome of events was recovering. The doctor's office appointment was a routine appointment unrelated to receiving the vaccine. The temporal relationship with the COVID vaccine was reconstructed by the patient afterwards after thinking about it in retrospect. No COVID tested post vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: TRAZODONE; CRESTOR; AMBIEN; GABAPENTIN; METFORMIN

Current Illness:

ID: 1022084
Sex: F
Age: 48
State:

Vax Date: 01/21/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
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: Fever, chills, herpes outbreak

Other Meds: D, Zinc, Venous Support, Magnesium, B Complex

Current Illness:

ID: 1022085
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
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: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for a female patient (Wife) of unknown age that received first dose of bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Pharmacist said wife had 1st dose of covid vaccine 3 weeks ago, then tested positive for covid virus. Has fever and slight cough. Wondering if she can get 2nd dose of covid vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the COVID-19 infection is possible due to lack of efficacy of suspect vaccine BNT62B2.

Other Meds:

Current Illness:

ID: 1022086
Sex: F
Age:
State: IN

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
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: Within 24 hours of the injection my atrial fibrillation reoccurred; This is a spontaneous report from a contactable consumer. A 72-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262), via an unknown route, on 23Jan2021 (at 13:15) at a single dose on the left arm for COVID-19 immunisation, administered at hospital. Relevant medical history included high cholesterol, high blood pressure and atrial fibrillation (she had been treated for Afib in the past but had been off of all medications for many months). Relevant concomitant medications included atorvastatin for high cholesterol and metoprolol for high blood pressure. No other vaccine was received in four weeks. Within 24 hours of the injection, on 24Jan2021 at 13:30, atrial fibrillation reoccurred. Physician office visit was done. Therapeutic measures taken as result of the event included apixaban (ELIQUIS) and dofetilide. An electrocardiogram (EKG) was done and results were unknown. Post-vaccination COVID test was not performed. The patient had recovered from the event in Jan2021.

Other Meds: ATORVASTATIN; METOPROLOL

Current Illness:

ID: 1022088
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. This consumer reported similar events for two patients. This is first of two reports. A patient of unspecified age and gender received first dose Covid-19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history includes patients were exposed to the virus. The patient's concomitant medications were not reported. The patient received first dose of the covid-19 vaccine and then contracted covid-19. Caller stated it is not an AE since her patients were exposed to the virus. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085847 Same reporter/ drug/ event for different patients.

Other Meds:

Current Illness:

ID: 1022089
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is 2nd of two reports. A patient of unspecified age and gender received the first dose of Covid-19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization. The patient medical history includes patients were exposed to the virus. The patient's concomitant medications were not reported. The patient received first dose of the covid-19 vaccine and then contracted covid-19. Caller stated it is not an AE since her patients were exposed to the virus. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085846 Same reporter/ drug/ event, different patient

Other Meds:

Current Illness:

ID: 1022090
Sex: M
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
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: Caller tested positive after the first shot/COVID; Caller tested positive after the first shot/COVID; He had a little bit of a cough but thought it was allergies; He had chills and sensitive skin; He had chills and sensitive skin; This is a Spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient said he was fortunate to have received the Pfizer COVID Vaccine. He was retired Navy. He received the dose at Hospital on 22Jan2021. Apparently at that time he had initial symptoms of COVID. He had a little bit of a cough but thought it was allergies. After the vaccine, the next few days his symptoms developed. His cough got worse. He had chills and sensitive skin. On 25Jan2021 he was tested for COVID. He got his results this morning and they were positive. He has been talking with online nurses and doctors. He has specific questions for Pfizer. Patient wanted to know about could the shot itself have contributed to a positive test from forming antibodies. Second dose was scheduled for 12Feb2021. Wanted to know if he should get that one. He pulled his back coughing too hard. He was headed to the Emergency Room (ER) to get treated because he cannot go anywhere else due to COVID. The outcome of the events was unknown with treatment received. Information on the batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1022091
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
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: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) reported that a 37 years old female patient received 2nd dose of BNT162B2 (Batch/lot number: EL1283/EH9899, Expiry Date: Mar2021) on 08Jan2021 at single dose on Left Deltoid, upper left arm for Covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient received both doses of Covid vaccine and tested positive for Covid day 18 post second dose. She received the second dose on 08Jan2021. However, she tested positive for COVID-19 on 24Jan2021. She wanted to know if she will be an asymptomatic carrier in the future. Outcome of the event was unknown. No follow-up attempts possible. No further information expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1022092
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: infection; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient resided in an assisted living facility. The patient experienced infection on an unspecified date with outcome of unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1022093
Sex: M
Age:
State: WV

Vax Date: 01/07/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital: Y

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: diabetic wounds; end stage heart failure; He tested positive for COVID; He tested positive for COVID; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (reported as COVID-19 vaccine), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of the COVID-19 vaccine on 07Jan2021. He tested positive for COVID on 27Jan2021. Patient was in hospice care. He went to the hospital for treatment of diabetic wounds on 20Jan2021. In addition to diabetes he had end stage heart failure on an unspecified date. Event took place after use of product. The event outcome was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1022094
Sex: U
Age:
State: MO

Vax Date: 01/22/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
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: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and fender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Jan2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received their Pfizer vaccine on 22Jan2021. The patient then tested positive for COVID on Monday, 25Jan2021. The patient was to receive a monoclonal antibody infusion, bamlanivimab. Patient had to wait 90 days to get the Pfizer vaccine. Pharmacist asked after that 90 days was up, should the patient get the second dose, or start the series over. The outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.

Other Meds:

Current Illness:

ID: 1022095
Sex: M
Age:
State:

Vax Date: 12/21/2020
Onset Date:
Rec V Date: 02/11/2021
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: This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored Program. A male patient of an unspecified age received first dose of BNT162B2 (Lot number: EK5730) on 21Dec2020, second dose of BNT162B2 (Lot number: EL1284) on 11Jan2021, and both via an unspecified route of administration at single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient stating that he received his first dose of Covax on 21Dec2020 Lot#EK5730 and his second dose of Covax on 11Jan2021 Lot# EL1284, stating that after testing IGM and IGG he is negative for antibodies. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1022096
Sex: M
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
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: ankle is kinda swollen; This is a spontaneous report from a Pfizer Sponsored Program, received by a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Jan2021 (a week ago, as reported) at a single dose for COVID-19 immunisation. Relevant medical history included arthritis (he took ibuprofen as needed when he had a flare up). No relevant concomitant medications were provided. After vaccination, patient's ankle is kinda swollen. He clarified that he was not taking ibuprofen since he has had vaccine and he wanted to know if he could retake it. The outcome of the event was unknown. Information about Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 1022097
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: tested positive after taking the first dose of the vaccine; tested positive after taking the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age and gender received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient tested positive after taking the first dose of the vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022098
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: positive for COVID 6 days post first dose/Sore throat/body aches; positive for COVID 6 days post first dose/sore throat/body aches; This is a spontaneous report from a contactable nurse. This report was received via a Pfizer Sales Representative. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date (reported as a Thursday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first shot on a Thursday. 5 days later patient was exposed to a COVID patient. Patient got tested for COVID-19 and tested positive for COVID 6 days post first dose. Day 7 post dose experienced sore throat and body aches. Events took place after use of product. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship. This case will be reassessed once additional information is available.

Other Meds:

Current Illness:

ID: 1022099
Sex: F
Age:
State: PA

Vax Date: 01/14/2021
Onset Date: 01/18/2021
Rec V Date: 02/11/2021
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: Contracted Covid on 18Jan; Contracted Covid on 18Jan; Nasal congestion; Fever; Headache; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a 63 years old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date 31Mar2021) via an unspecified route of administration on 14Jan2021 around 8:30am-8:45am (vaccine location: left upper arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history included compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergic to sulfa when she was a child, seasonal allergies, graves disease in 2014, which was been in remission for the last few years. Other medical history included high cholesterol. Family history included Her mother has Type II Diabetes; she has some unknown cancers in her family; no further information to provide. There was none other prior vaccinations (within 4 weeks). The concomitant medications were reported as ongoing atorvastatin at 40mg taken once daily for High cholesterol (Taken for a long time, at least 10 years).The day after she got the Pfizer COVID- 19 Vaccine she was around someone who had traveled who she did not realize had not quarantined and had seen relatives who were positive for COVID. Patient was contracted Covid on 18Jan2021 (possibly overnight while sleeping or early morning) and had Mild symptoms. First started with nasal congestion; then developed fever; headache; and body aches. Events has improved, she has gotten much better; just been having a fever on and off and nasal congestion but getting better every day; still just having a little bit of symptoms. She was diagnosed with COVID after that administration. She is not saying the vaccine gave her COVID. She called to ask if she should still get the second dose of Pfizer COVID-19 Vaccine as scheduled for 04Feb2021 with this diagnosis. Rapid COVID test (nasal swab) on 21Jan2021 and Positive for COVID. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: ATORVASTATIN

Current Illness: Chromosomal abnormality NOS; Diabetes; Endocrine disorder; Graves' disease (in remission); Immune system disorder; Obesity; Respiratory disorder; Seasonal allergy; Sulfonamide allergy (when she was a child)

ID: 1022100
Sex: M
Age:
State: IL

Vax Date: 01/01/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
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: First covid-19 vaccine dose 2 weeks ago, tested positive for covid-19; First covid-19 vaccine dose 2 weeks ago, tested positive for covid-19; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient received first covid-19 vaccine dose 2 weeks ago(Jan2021), tested positive for covid-19 on 21Jan2021, he was questioning if he should have the second dose of covid-19 today as scheduled. The patient underwent lab tests and procedures, which included tested positive for covid-19 on 21Jan2021. The outcome of the events was unknown. Information on the Lot/Batch number has been requested

Other Meds:

Current Illness:

ID: 1022101
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: Grandma was tested positive 11 days after the first dose; Grandma was tested positive 11 days after the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporter's grandmother) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was tested positive 11 days after the first dose. Grandmother had an appointment for 2nd dose on 30Jan2021 and tested positive after 1st dose. He said his grandmother had a test again on an unknown date but this time she's negative for Covid-19. The outcome of the events was recovered on an unknown date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022102
Sex: F
Age:
State: AR

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 02/11/2021
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: swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EJ1685, via an unspecified route of administration on 22Dec2020 at 11:30, at 68 years of age, at single dose for COVID-19 immunization. Medical history included rheumatoid arthritis diagnosed 3 years before this report, coronary artery disease she has had for about 10 years and takes losartan for it, COVID-19 infection from Mar2020 to an unknown date; her family history is relevant for diabetes mellitus. In 2019 the patient got 2 flu vaccines at the same time, the regular flu and the one for seniors, and also the pneumonia shot. So she got 3 vaccines at once. Afterward she got sick and was in bed with chills and everything, she couldn't eat and was sick for the day. It was explained that she was at work but left for the day. This only lasted for the one day and she was fine and back to work the next day. There were no concomitant medications. On 23Dec2020 the patient experienced swollen lymph nodes on her left side; she got the shot on that side due to bad arthritis on the right side. It wasn't that bad and disappeared after 2 days. She did tell the doctor and was told by the doctor it was thought to just be inflammation from the shot. The patient recovered from the reported event on an 25Dec2020.

Other Meds:

Current Illness:

ID: 1022103
Sex: F
Age:
State: GA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
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: got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; her hands and feet were cold; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 25Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that while on the way home, the patient got real sick, she had a 102 fever, had chills and was freezing to death, and was nauseous. She is feeling a lot better than she did earlier. The husband put a heating pad on her feet, her hands were cold, she had chills, she was cold all over, when you touched her, her hands and feet were cold. The first time he checked, her temperature when she was first home was 101.7, then went up to 102, and stayed there for a while, but she feels like it came down. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022104
Sex: F
Age:
State: NC

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/11/2021
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: pain, redness, itching at site; pain, redness, itching at site; pain, redness, itching at site; Muscle ache; heaviness to arm; overall malaise; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number Ek9231), via an unspecified route of administration, on 13Jan2021 10:30 AM, in right arm as single dose for COVID-19 immunisation. The patient was vaccinated at workplace clinic. Patient age at vaccination was 56 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. Concomitant medications were not reported. On 13Jan2021 at 10:30 AM the patient experienced pain, redness, itching at site, muscle ache and heaviness to arm plus overall malaise as well lasting 2 weeks (clarification requested). No treatment was received for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has been tested for COVID-19 (Nasal Swabs, on 14Jan2021; 19Jan2021; 21Jan2021; 25Jan2021, all with negative result).

Other Meds:

Current Illness:

ID: 1022105
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received 1st dose of covid vaccine on Friday. Monday patient had tested positive. Called would like to know if and when patient can get 2 dose of covid vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022106
Sex: F
Age:
State: SC

Vax Date: 01/01/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
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: Her sister was diagnosed with covid today 27Jan2021/Positive with covid after the first dose; Positive with covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable nurse (patient's sister). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on unknown date in Jan2021 at single dose on right arm for preventative. Medical history and concomitant medications were not reported. Reporter's sister had gotten COVID in between the two vaccine doses. She clarified that her sister only had the first dose of the vaccine. Her sister was diagnosed with COVID today 27Jan2021. Lab data included SARS-CoV-2 test positive on 27Jan2021. Her sister will be done with quarantine the day before she gets her second dose. She was calling to ask if her sister can get the second dose. She read all the information and she thought it should be ok for her sister to get the second dose. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1022107
Sex: F
Age:
State:

Vax Date: 01/31/2021
Onset Date: 01/31/2021
Rec V Date: 02/11/2021
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: Pregnant at the time of vaccination: Yes; She is pregnant at time of vaccination; She is pregnant at time of vaccination; first, covid 19; first, covid 19; This is a spontaneous report from a non-contactable consumer A 33-year-old pregnant female patient received bnt162b2 (BNT162B2; Solution for injection) via an unspecified route of administration on 31Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had last menstrual on 31Jan2021. She is pregnant at time of vaccination while taking bnt162b2. On an unknown date in 2021, patient had first, covid 19. The mother was due to deliver on 07Nov2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. There was no treatment for the event covid 19. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1022108
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 01/12/2021
Rec V Date: 02/11/2021
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: covid positive; covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (patient) of an unspecified age reported that she received the first dose of 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 medical history and concomitant medications were not reported. The patient was covid positive on 12Jan2021 with outcome of unknown. The patient underwent lab tests included covid-19 virus test: positive on 12Jan2021. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022109
Sex: F
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
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: she had quite a rash, it was red, right where the injection was made; it was warm; her arm was hurting a bit; slight headache; This is a spontaneous report from a contactable consumer (patient) and contactable physician. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration at arm left on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history included COVID-19 (with symptoms: terrible headache, cough, shortness of breath for good 6 weeks and fatigue) from Nov2020 to an unknown date. The patient experienced slight headache on 23Jan2021, her arm was hurting a bit on 25Jan2021. On 26Jan2021, her arm was still sore, it was warm, she had quite a rash, it was red, right where the injection was made, the rest was more pink. The patient outcome of headache was recovered on 24Jan2021, the outcome of the other events was not recovered.

Other Meds:

Current Illness:

ID: 1022110
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: positive for the COVID-19 Virus; positive for the COVID-19 Virus; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history included congestion. Concomitant medications were unknown. She said she didn't realize she was asymptomatic, and tested positive for the COVID-19 Virus. She said she had already received her first COVID-19 Vaccine dose before she was told she was positive for the COVID-19 Virus. Consumer asked if she should delay getting the second dose of the COVID-19 Vaccine, or does she need to start from scratch. She asked if Pfizer has any specific COVID-19 Vaccine protocol for someone who has tested positive for the COVID-19 Virus after already receiving a COVID-19 Vaccine dose. Reported she had been experiencing some congestion, so she decided on a Monday to get tested for the COVID-19 Virus. She said her COVID-19 Virus test was negative. She said on that Friday she was still congested. She said she had her first COVID-19 Vaccine dose earlier on that Friday. She said after she had received the COVID-19 Vaccine on that Friday, someone who she had been in close contact with tested positive for the COVID-19 Virus. She said since her congestion started, she had developed other symptoms, so she retested for the COVID-19 Virus later in the day that Friday. She said she received a positive COVID-19 Virus test result on Monday. She said she was guessing that the was positive for the COVID-19 Virus at the time she received her first COVID-19 Vaccine dose on that Friday. Reported she looked at Pfizer's Medical Information website to see if she needed to repeat her first COVID-19 Vaccine dose, and didn't find any information directly related to her situation. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested.

Other Meds:

Current Illness:

ID: 1022111
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 2nd of 4 patient. A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has tested positive for covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1022112
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 3rd of 4 patient. A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for Covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1022113
Sex: F
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
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: checked for antibodies and had none; This is a spontaneous report from a contactable physician via a sales representative. A female patient of an unspecified age received first and second doses of 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 medical history was not reported. The patient's concomitant medications were not reported. The patient stated that she completed her two dose series of the Pfizer vaccine, waited a week and checked for antibodies and had none. Outcome of event was not recovered. information about lot and batch number has been requested.

Other Meds:

Current Illness:

ID: 1022114
Sex: F
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/17/2021
Rec V Date: 02/11/2021
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: Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.

Other Meds:

Current Illness:

ID: 1022115
Sex: F
Age:
State: AR

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
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: Ringing in ears; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3246) at single dose, in the left arm, on 25Jan2021, at 04:45 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included metoprolol, gabapentin, triamcinolone acetonide (SYMCORT), chlorthalidone and doxepin. On 26Jan2021, the patient experienced ringing in ears. No treatment was received. Clinical outcome of the adverse event was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19.

Other Meds: METOPROLOL; GABAPENTIN; SYMCORT; CHLORTHALIDON; DOXEPIN

Current Illness:

ID: 1022116
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 02/11/2021
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: Lower extremity myalgia; Right hip pain; Fever; This is a spontaneous report from a non-contactable physician. A 26-year-old male patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, lot number: EL324), intramuscular on 01Feb2021 07:00 at single dose for covid-19 immunisation. No other medical history, allergies to medications, food, or other products and concomitant medications were reported. Prior to vaccination the patient diagnosed with COVID-19 was unknown. The past medication included first dose of BNT162B2 (COVID 19, Pfizer, lot number: EK4176), intramuscular on 11Jan2021 07:00 at single dose for covid-19 immunisation. The patient experienced lower extremity myalgia, right hip pain and fever on 02Feb2021 07:00. The patient received acetaminophen as therapeutic measures of events. The outcome was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1022117
Sex: F
Age:
State: NY

Vax Date: 01/16/2021
Onset Date: 01/31/2021
Rec V Date: 02/11/2021
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: Ache in the lower left rib cage and left side; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 43-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL32Y6), via an unspecified route of administration on left arm on 16Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included congenital heart defect and dairy sensitivity. The patient's concomitant medications were not reported. The patient experienced ache in the lower left rib cage and left side on 31Jan2021 12:00. The adverse event result in doctor or other healthcare professional office/ clinic visit. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The event was assessed as non-serious by the reporter. The outcome of the event was reported as not recovered.

Other Meds:

Current Illness:

ID: 1022118
Sex: M
Age:
State: CA

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
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: high blood pressure; headache; body aches; joint pain; fatigue; lack of appetite; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e79263), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient medical history included high cholesterol and high blood pressure (controlled with medication), both from an unknown date and unknown if ongoing. The patient's concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) on 30Dec2020 at single dose for immunization, paracetamol (TYLENOL), atorvastatin and olmesartan medoxomil (BENICAR). On 25Jan2021, the patient experienced high blood pressure, headache, body aches, joint pain, fatigue and lack of appetite. No therapeutic measures were taken in response to the events. The patient outcome of the events was not recovered.

Other Meds: TYLENOL; ATORVASTATIN; BENICAR

Current Illness:

ID: 1022119
Sex: F
Age:
State: MO

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
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: Fever; Headache; Chills; Feeling like a heavy weight on her body; Back pain; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EZ3247), via an unspecified route of administration in the left arm on 23Jan2021 at 15:20 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included gestational diabetes (first pregnancy) from an unknown date to an unknown date and two pregnancies on unknown dates. Concomitant medications included unspecified post-natal multivitamins and paracetamol (TYLENOL; Lot Number: SBA22; Expiration Date: Jan2023) taken before getting the vaccine on 23Jan2021 to prevent soreness. The patient previously received the first dose of BNT162B2 on 03Jan2021 (at the age of 34-years-old; Lot Number: EL0142) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 24Jan2021 at 04:00, the patient experienced chills and had a feeling like a heavy weight on her body. On 24Jan2021 at 07:00, the patient had a fever and headache. On 24Jan2021, she also had back pain. The clinical course was as follows: On 23Jan2021, the patient took paracetamol before getting the vaccine as she heard one can feel sore after getting it. The patient received the second dose on 23Jan2021 at 15:20. The patient was okay after she got the vaccine. However, early the next morning (24Jan2021), she had shivering without any fever (later referred to as chills). The chills were something she never experienced in her life. It was like she was in the cold. She could not move, it was that bad. She felt a heavy weight on her whole body. She could not get out of bed. A few hours later at 07:00, she checked her temperature and it was 102.5 degrees Fahrenheit. She took paracetamol. The headache started with the fever around 07:00. She stated she kept taking paracetamol. She did try to stop using paracetamol, but without it, the headache was still there. The back pain was also severe on 25Jan2021. The chills recovered on 25Jan2021 and the fever was recovered on 26Jan2021. The clinical outcomes of the headache and felt like a heavy weight on the body were unknown; while that of the back pain was not recovered. The events of chills, fever, headache, and back pain were reported as serious by the patient (nurse) for being medically significant. The patient (nurse) assessed the events of chills, fever, headache, back pain, and felt like a heavy weight on her body were related to the vaccine.; Sender's Comments: Based on a compatible temporal association and known BNT162B2 vaccine safety profile causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) 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: TYLENOL

Current Illness:

ID: 1022120
Sex: F
Age:
State: TX

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 02/11/2021
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: Severe chills; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received bnt162b2, via an unspecified route of administration on 30Jan2021 at 04:45, single dose in the Left arm for covid-19 immunization. Medical history included Hashimotos Thyroiditis. Concomitant medication included thyroid (ARMOUR THYROID). The patient previously took Levoquine and experienced allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Feb2021, the patient experienced severe chills and joint pain still 4 days later. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds: ARMOUR THYROID

Current Illness:

ID: 1022121
Sex: M
Age:
State: WA

Vax Date: 01/21/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
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: Dizziness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021at a single dose in left upper arm for Covid-19 immunisation at the age of 73-year-old. Lot number was EL9262. Medical history and concomitant medications were none. On 26Jan2021, the patient experienced Dizziness, it started in the morning, when he got out of bed, the first time he woke was at 5 AM and right at the time of report it was going on 11 AM and he was taking it easy, sitting back and relaxing, he fell asleep. The patient did not recover from the event.

Other Meds:

Current Illness:

ID: 1022122
Sex: M
Age:
State: NJ

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/11/2021
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: On 25Jan2021 tested positive for COVID; On 25Jan2021 tested positive for COVID; Headache; Loss of appetite; Dry skin patches; This is a spontaneous report from a Contactable Consumer (patient) via a Pfizer-sponsored program. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 18:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Prior Vaccinations within 4 weeks. The patient took the first dose of the COVID vaccine on 08Jan2021 and was due to get his second dose but on 25Jan2021 tested positive for COVID. The patient wanted to know if he was allowed to take the second dose. He had a PCR nasal swab that showed the positive COVID diagnosis. He took headache medication after, Tylenol. He had a headache starting on 21Jan2021 and it was lingering on and off but has resolved at this point. He noticed about 8-9 pm the night he got the shot, 08Jan2021, on both feet he had dry skin patches and this lasted about 2 hours; it resolved as this point. He also had a loss of appetite the next day though he ate anyway. That lasted about 8 hours. The outcome of Loss of appetite, Dry skin patches, Headache was resolved. The outcome of other events was unknown. Information about Lot/ Batch has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm