VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1767566
Sex: U
Age:
State: SC

Vax Date: 05/04/2021
Onset Date: 08/06/2021
Rec V Date: 10/07/2021
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: Sick with covid; Sick with covid; Sick with Covid; extreme chills; no taste; sore; can't really move; GI issues; headache; slight cough; This is a spontaneous report from a non-contactable consumer (patient). This is the first of two reports with events experienced under the first dose. A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 04May2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 06Aug2021 patient experienced sick with covid, extreme chills, no taste, sore, can't really move, Gastrointestinal (GI) issues, headache and slight cough. It was reported that on 06Aug2021 patient was sick with Covid and following symptoms: No fever but extreme chills, no taste, sore, can't really move, GI issues, headache, and slight cough. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265501 Same patient and drug, different event and dose

Other Meds:

Current Illness:

ID: 1767567
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: Covid test; Test Result: Negative

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: I start to panic; mental problems; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number and Expiry date: unknown), via an unspecified route of administration, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included heavy head cold. It was reported that she does not normally take vaccines, flu or otherwise, only had a tetanus. Lived on a farm on a board, rusty nail, rushed and got tetanus shot. Concomitant medications were not reported. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On an unknown date, the patient felt panic. The patient had mental problems and decided not to get the second shot. The patient underwent lab tests and procedures, which included Covid test showed result negative. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1767568
Sex: F
Age:
State:

Vax Date: 09/17/2021
Onset Date:
Rec V Date: 10/07/2021
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: not quite IM in the Deltoid, it was potentially located more towards the elbow; chills; I felt a little off; local reaction with redness at the site of the injection; local reaction with redness at the site of the injection; it felt hot; she received her booster dose, 3rd dose, of the Pfizer COVID19 Vaccine; she received her booster dose, 3rd dose, of the Pfizer COVID19 Vaccine; This is a spontaneous report from a contactable pharmacist (patient son), from Pfizer medical information team. A 65-year-old female patient (nurse) received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 17Sep2021 as dose 3 (Booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), received via an unspecified route of administration on Jan2021 as dose 2, single for COVID-19 immunization. It was reported that, the pharmacist, calling on behalf of his mother, also on the line and also a RN, states she received her booster dose, 3rd dose, of the Pfizer COVID19 Vaccine 17SEP2021 and they have concerns that the vaccine was given in the wrong region of the arm. The reporter states that the injection was given not quite IM in the Deltoid, it was potentially located more towards the elbow. Patient states that it was given too low and was mid way from her acromial process and elbow, given at 90 degree angle. May have hit a muscle; it was bicep or tricep. The patient is a 65 year old female who is school nurse and fighting it everyday out there. Each of the reporters, the patient and the son have read the CDC document regarding not having to repeat dose and potential worsening local or systemic side effects, they state they hope it still as effective. Reporter wants to know if her booster dose is effective enough to really have boosted her immunity since she had 2nd dose 8 months ago. The reporter does report also his mother having systemic side effects, chills and some redness but that is all he states. The son saw a picture of it. The patient states that she did have a local reaction with redness at the site of the injection. Started and it felt hot like any other reaction to an IM injection and it was low. she knew where the Band-Aid was placed, she thought it was a little low and the redness really made me think it was low. Patient further states that the next day, she felt a little off. Maybe she did get a dose of it in the IM. Like she said, she dont know... she dont think it went in the deltoid at all, if so it went bicep or tricep. Reporter was hoping to get something regarding efficacy but states obviously information is not known. The reporter states he is speculating but hoping she has some immune response but unable to back this up with data as he is speaking to his mother during the call. The patient states she did report it to the pharmacy to have them enter into the VAERS database as a vaccine error because she felt it was or she wouldn't have perused it. The reporters are calling today to see if we have any clinical data for potential wrong route of administration and the efficacy of the product thereafter such an event. The outcome of the events was unknown. Batch/lot number not reported it will be requested during follow-up activities.

Other Meds:

Current Illness:

ID: 1767569
Sex: F
Age:
State: NV

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: fever; Result Unstructured Data: Test Result:102

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: chills; fever 102; headache; stomach; fatigue; arm pain; immediatly felf dizzy; nausea after shot; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in right arm on 23Feb2021 (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included covid-19 from 03Jan2021 to 24Jan2021. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 45-years-old) as dose 1, single for COVID-19 immunization after which the patient experienced chills, fever, headache, stomach discomfort, fatigue and arm pain. The patient experienced chills, fever 102, headache, stomach discomfort, fatigue, arm pain on an unspecified date and dizzy and nausea after shot on 23Feb2021. The outcome of all the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1767570
Sex: F
Age:
State: NY

Vax Date: 09/25/2021
Onset Date: 09/25/2021
Rec V Date: 10/07/2021
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: Vomiting; Diarrhea; Fever; Knee and ankle pain; Fatigue; Headaches; Dehydrated; This is my 3rd dose; This is my 3rd dose; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FL 3183), via an unspecified route of administration, administered in Arm Left on 25Sep2021 13:45 as DOSE 3, SINGLE for covid-19 immunisation (at the age of 45 years). Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history included rubber sensitivity from Latex , drug hypersensitivity from Penicillin and Sulphate. Concomitant medications included doxycycline and tessalon perle. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient previously took first and second dose of BNT162B2 for covid-19 immunisation. The patient experienced vomiting, diarrhoea, fever, knee and ankle pain, fatigue, headaches, dehydration, off label use and immunisation on 25Sep2021 16:45. Since the vaccination, the patient had not been tested for COVID-19. Treatment received was unknown. The clinical outcome of the events was recovered for vomiting, diarrhoea, fever, knee and ankle pain, headaches, dehydration and unknown for Off label use, booster, fatigue. Follow-up (28Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: DOXYCYCLINE; TESSALON PERLE

Current Illness:

ID: 1767571
Sex: F
Age:
State:

Vax Date: 09/22/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: He and his wife received the third dose of the Covid-19vaccine; He and his wife received the third dose of the Covid-19vaccine; They have also received the Influenza Flu vaccine on the same day; His wife can barely walk; Weak; Headache; This is a spontaneous report from a non-contactable physician reported from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Sep2021 as dose 3 (booster), single for COVID-19 immunisation; influenza vaccine (INFLUENZA) via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as single for immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration on an unspecified date as single, and dose 2 via an unspecified route of administration on an unspecified date as single, both for COVID-19 immunisation. The patient experienced as, he and his wife received the third dose of the covid-19vaccine, they have also received the influenza flu vaccine on the same day on 22Sep2021, his wife can barely walk, weak, headache on Sep2021. Reported as, reporter and his wife (patient) received the third dose of the Covid- 19 vaccine yesterday. They have also received the Influenza Flu vaccine on the same day. Reporter told that his wife (patient) can barely walk, was weak and has a headache. Outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1767572
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/07/2021
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: COVID-19; COVID-19; TROUBLE SLEEPING; Right Lung Weak; Voice was different and felt like were going to die; Impending doom; This is a solicited report based on information received by Pfizer (manufacturer control number: 21K-163-4084076-00) from a contactable consumer(patient) A 69-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 01Mar2021 at single dose intramuscular for COVID-19 immunization and adalimumab (HUMIRA) for moderate to severe rheumatoid arthritis. Relevant medical history included Moderate to Severe Rheumatoid Arthritis. Concomitant medications were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02May2021 at single dose intramuscular for COVID-19 immunization. On an unspecified date the patient experienced vaccination failure, COVID- 19, trouble sleeping, right lung weak, voice was different and felt like were going to die and impending doom. At the time of the reporting event outcome was unknown. The reporter's causality for all the reported events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was provided as possible. The reporter's causality for the event of covid-19 with Humira(adalimumab) was provided as no reasonable possibility. The Reporter's causality for the events of trouble sleeping, right lung weak, Voice was different and felt like were going to die with Humira(adalimumab) was not provided. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19, insomnia (non-serious) , lung disorder (non-serious), dysphonia (non-serious) and anxiety (non-serious) and BNT162B2.

Other Meds: HUMIRA

Current Illness:

ID: 1767573
Sex: U
Age:
State:

Vax Date: 08/27/2021
Onset Date: 09/23/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210923; Test Name: COVID-19 test; Test Result: Positive

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Tested positive of COVID-19; Tested positive of COVID-19; This is a spontaneous report from a non-contactable consumer (patient) via the Pfizer sponsored program. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 27Aug2021, as 1st single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Sep2021, the patient was sick and tested positive for COVID-19. The patient was asking if they could get the 2nd dose. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1767574
Sex: F
Age:
State:

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/07/2021
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: I have been bleeding from my finger nail; This is a spontaneous report from a contactable nurse (patient herself). A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration, on 22Sep2021 at single dose (dose number unknown) for COVID-19 immunization. No relevant medical history and concomitant medications were provided. On 22Sep2021, the patient has been bleeding from her finger nail. The outcome of the event wass unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Hemorrhage 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:

Current Illness:

ID: 1767575
Sex: M
Age:
State: OH

Vax Date: 03/29/2021
Onset Date: 09/15/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210915; Test Name: COVID 19; Result Unstructured Data: Test Result: Positive.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: positive for COVID; positive for COVID; like a bad flu; shortness of breath with activity; Headache; head congestion; Fatigue; mild coughing to bring up flem; This is a spontaneous report from a contactable nurse (patient). A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6201, Expiry date: not reported), via an unspecified route of administration in left arm on Feb2021 as dose 1, single for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730, Expiry date: not reported), via an unspecified route of administration in left arm on 29Mar2021 15:00 (at age of 71-years-old) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from Dec2020 to an unknown date States he and his wife got the COVID virus back in Dec2020. Patient's medical history (including any illness at time of vaccination) were none. Family medical history relevant to adverse event were none. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. There were no adverse events following prior vaccinations. Additional vaccines administered on same date of the bnt162b2 suspect were none. On 15Sep2021, the patient experienced positive for covid, like a bad flu, shortness of breath with activity, headache, head congestion, fatigue, mild coughing to bring up flem. Registered nurse called regarding the bnt162b2 vaccine. Stated he and his wife got the COVID virus back in Dec2020. Added he thought he might have more immunity having had it and then getting the shot. Added their symptoms were very minimal and they were told to wait 90 days for the COVID vaccine. Reports they got the vaccine in Mar2021; then on the 16Sep2021 he was positive for COVID. Added he imagined it was the new variant. His wife also had symptoms at the same time. Patient mentioned that he ate a low carb diet, he had eliminated sugar, and had lost 90 pounds; he thought low sugar helps and that a high blood sugar puts you at risk. Reports he noticed symptoms of the virus and got tested on 15Sep2021. He experienced fatigue; shortness of breath with activity; headache; mild coughing to bring up flem; head congestion. Stated the head congestion had been the worst for him and wife. Rated his events all as medically significant. States he was improving. The adverse events did not result in Emergency Room or Physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Sep2021. Treatment: Reports he tested positive for COVID and went into isolation. Therapeutic measures were taken as a result of the events. The outcome of the events like a bad flu, shortness of breath with activity, headache, head congestion, fatigue, mild coughing to bring up flem was recovering. Indication was he wanted to prevent COVID. When asked causality he stated no, not related. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events covid19, drug ineffective, influenza like illness, dyspnoea, headache, head discomfort, fatigue and cough cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1767576
Sex: M
Age:
State: NC

Vax Date: 01/20/2021
Onset Date: 09/13/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210913; Test Name: COVID-19 Test; Test Result: Positive ; Comments: result on 15Sep2021

Allergies:

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

Symptoms: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from contactable consumer (patient's parent). A 34-years-old male patient of received at the age of 33-years-old second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm on 20Jan2021 (Batch/Lot number was not reported) as dose 2, single, and first dose via an unspecified route of administration, administered in arm three weeks before the second on Dec2020 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient received the doses probably in the morning, but can't guarantee. The route was reported as arm, but unknown which arm. First dose was the side he sleeps on, second dose was the opposite arm. Medical history included arm soreness from an unknown date and unknown if ongoing. There were no concomitant medications. The patient tested positive for COVID-19. Had the Pfizer COVID-19 Vaccines. He was an Athletic Trainer. Patient started feeling bad on 10Sep2021-11Sep2021. Didn't do a rapid COVID test, did the extensive test. Test was done by his work. Is employed with Health System. Employer had patient come in on Monday for a COVID test and was confirmed he was positive. Went for the COVID-19 test on Monday, 13Sep2021, results came back positive on Wednesday, 15Sep2021. Went back to work on 22Sep2021. Patient is feeling fine. COVID-19 Vaccine saved him from being in the hospital. The patient received his COVID-19 test at a hospital facility, but it was done outside. Did not have to see a doctor. The patient had heavy contact with unvaccinated people because of his job. Before he got COVID-19 tested, patient thought he had a cold. Patient used an antihistamine and Tylenol. Then patient lost smell and taste. At the time of reporting the patient was good and back and to work. Only felt bad for a day or two. The outcome of event was resolved on an unspecified date in Sep2021. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767577
Sex: F
Age:
State: IN

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210924; Test Name: Fever; Result Unstructured Data: Test Result:102.7

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Fever 102.7; Chills; Sweats; Fatigue; Nausea; Headache; Body aches; from the booster- 3rd shot; from the booster- 3rd shot; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Right on 24Sep2021 11:00 (At the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. No relevant past drug history, known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 and dose 2 via an unspecified route of administration (At the age of 39-year-old) as single dose for COVID-19 immunisation and the patient previously received FLU vaccine via an unspecified route of administration, administered in Arm Left on 23Sep2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Sep2021 23:00 the patient experienced fever 102.7, chills, sweats, fatigue, nausea, headache, body aches, from the booster- 3rd shot. The patient underwent lab tests and procedures which included body temperature: 102.7 on 24Sep2021. The outcome of the event from the booster- 3rd shot was unknown and outcome of other events was not recovered, The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767578
Sex: F
Age:
State: OH

Vax Date: 03/28/2021
Onset Date: 09/15/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 202012; Test Name: Covid-19 test; Test Result: Positive

Allergies:

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

Symptoms: like a bad flu; congestion; they thought she must have the COVID virus as well; they thought she must have the COVID virus as well; Headache; more fatigue; loss of appetite; This is a spontaneous report from a contactable Nurse (patient's husband) via Pfizer sponsored program. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8730) via an unspecified route, administered on Left arm on 28Mar2021 in the morning (71-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The report was related to study or programme. Vaccination facility type was reported as pharmacy. The patient's medical history included asthma, Covid-19 from Dec2021 to an unknown date. The patient's family medical history was reported as none. The patient's concomitant medications were not reported. No additional vaccines were administered on the same date of Pfizer suspect. The patient had not received any other vaccine within four weeks prior to vaccination. The patient had not experienced any adverse events following prior to vaccinations. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: Unknown) via an unspecified route, administered on Left arm on 28Feb2021 in the morning (71-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. Registered nurse called regarding the Pfizer COVID 19 vaccine. The reporter stated he and his wife got the COVID virus back in Dec2020. Added their symptoms were very minimal and they were told to wait 90 days for the COVID vaccine. Reported they got the vaccine in Mar2021; then on the 16Sep2021 he was positive for COVID. Added he imagined it was the new variant. His wife also had symptoms at the same time. Reported his granddaughter, who lives with them, had the first dose 10Sep2021 but then showed symptoms of the virus on 14Sep2021. He took her to have the COVID test and it was positive. They all got like a bad flu. She had asthma so he wanted to verify she had COVID so they could put her on steroids prophylactically. She was not tested but had the same symptoms at the same time on 15Sep2021, as the reporter who tested positive for COVID so they thought she must have the COVID virus as well. He reported that his wife had more fatigue; congestion; headache; and loss of appetite. Added she was so fatigued she was going to bed at 10:00 PM. No relevant tests were reported. These adverse events did not result emergency room/physician office visit. Rated all of patient's events as medically significant. States she was improving. When asked causality reports stated no, not related. The outcome of the events influenza like illness and nasal congestion, headache, fatigue, and loss of appetite were recovering, drug ineffective and suspected covid19 were unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Decreased appetite, Suspected Covid-19, Drug ineffective, headache , Nasal Congestion, Influenza like illness,Fatigue )and the administration of the 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:

Current Illness:

ID: 1767579
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: having reaction to the vaccine./I really don't feel good; This is a spontaneous report from a contactable consumer reported for self. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Reason for no lot number: of COVID-19 Vaccine: Complainant hung up abruptly/transfer incomplete. The patient medical and concomitant medication history were reported. Patient stated, really did not feel good and really can not understand. Patient had reaction to the vaccine. Patient went to the emergency room and nobody can help patient. Patient was unwilling to share further information, hence, product details (LOT#, expiration date, NDC#, UPC#) and other details were unknown. The outcome of event was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767580
Sex: F
Age:
State: FL

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 10/07/2021
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: Throat felt enclosed; redness on neck; difficulty breathing; hives on chest, arm, and head; nausea; diarrhea; fever; This is a spontaneous report from a contactable consumer reported for herself. A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FC3182; Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 17Sep2021 16:00 (at the age of 30-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included zinc (ZINC); vitamin c [ascorbic acid] (VITAMIN C); fish oil (FISH OIL); folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced throat felt enclosed, redness on neck, difficulty breathing, hives on chest, arm, and head, nausea, diarrhea, fever on 18Sep2021 10:30. Therapeutic measures were taken as a result of the events. AE (adverse event) resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for AE. AE treatment included nausea medication. There was no prolonged hospitalization. The events were not serious and seriousness criteria included none. Clinical outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: ZINC; VITAMIN C; FISH OIL; FOLIC ACID

Current Illness:

ID: 1767581
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: cough after two months it stopped, and started back; had booster shot in 2021; had booster shot in 2021; This is a solicited report based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4085446-00). A contactable consumer (patient herself) reported a 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) (at the age of 64-years-old) as dose 3 (booster), single for COVID-19 immunisation; influenza vaccine via an unspecified route of administration on 2021 (Batch/Lot number was not reported), as single dose for immunization and adalimumab (HUMIRA solution for injection in pre-filled syringe), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, as citrate free for moderate to severe rheumatoid arthritis. Medical history included asthma and rheumatoid arthritis. Concomitant medication included hydrocortisone (CORTIZONE) taken for unknown indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (at the age of 64-years-old); both intramuscular and for COVID-19 immunisation and experienced bad foot problems lost all functions of toes, nine toe fracture, dietary restrictions, did not felt great with grains, dark veggies, cough, pain in hip, angst in body sounds like body was fighting itself. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had booster shot in 2021 and got flu shot. In 2021, she had cough after two months it stopped and started back. She takes inhaler for life history of asthma. The action taken in response to the events for adalimumab was unknown. Outcome of event was not recovered. The reporter assessed the event as Other medically important condition. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event of cough and with Humira (Adalimumab) was a reasonable possibility. The reporter's assessment of the causal relationship of the event with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Cough" and suspected vaccine BNT162B2 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: CORTIZONE

Current Illness:

ID: 1767582
Sex: F
Age:
State: OH

Vax Date: 03/02/2021
Onset Date: 08/16/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:190/100; Test Name: blood pressure; Result Unstructured Data: Test Result:125/82; Test Name: Fever; Result Unstructured Data: Test Result:100.3; Test Name: Fever; Result Unstructured Data: Test Result:97.5; Test Name: PET; Result Unstructured Data: Test Result:osteoporosis; Test Date: 20210816; Test Name: Covid test; Test Result: Positive ; Comments: swab up her nose thing for COVID; Test Name: X-ray; Result Unstructured Data: Test Result:little nodule on the right side and that she had l; Comments: they saw a little nodule on the right side and that she had little collapsed air sacs at the bottom, they called it mild alterio bilateral (documented as provided by caller), but they were not concerned with that.

Allergies:

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

Symptoms: felt sick but she had fatigue for 10 days; cough got so bad; headache; received their Pfizer COvid-19 Vaccine series, tested positive for COVID-19.; received their Pfizer COvid-19 Vaccine series, tested positive for COVID-19.; viral bronchitis; sneezing all day; sore throat from her seasonal allergies and then it just got horrible, the sore throat did; sore throat from her seasonal allergies and then it just got horrible, the sore throat did; blood pressure there was 190/100/blood pressure was 125/82; little nodule on the right side; fever of 100.3; felt sick but she had fatigue for 10 days; This is a spontaneous report from contactable consumer (patient) via a Pfizer sponsored program support. A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number-EN6200) via an unspecified route of administration on 02Mar2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number E19267) via an unspecified route of administration on 11Feb2021 (age at the time of vaccination was 69-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history included osteoporosis, when she was in her 40s she had the flu for a week, she could not get out of bed because her fatigue was that bad and she already had a sore throat, post nasal drip from her seasonal allergies. There were other products. The patient's concomitant medications included ongoing alendronate sodium (FOSAMAX), 70 mg weekly, indicated for osteoporosis from 01Aug2021. It was reported that Patient had 2nd doses back in Mar2021 and then both her and her husband had breakthrough COVID cases. She tested positive on 16Aug2021. Hers also went into viral bronchitis. The caller is calling today because she is wondering about the booster vaccine, it says to get it at least 6 months afterwards but how soon should she get it after having COVID. Caller states that her specific question is if they both had the Pfizer COVID vaccine and then had the breakthrough case of the delta variant when should they get the booster. She confirms that she would like to complete the report prior to speaking to medical information because the isn't keeping track and she knows of 20 people who have had COVID and none of them have had any contact with each other including her 40 year old nephew who is vaccinated and was as sick as her and she doesn't know why. For the booster is says to wait at least 6 months but does that mean no sooner than 6 months or what. It is very confusing. Attempted to confirm when the viral bronchitis had began and she started to speak on how her case of COVID was like the worst case of the flu that she has ever had, when she was in her 40s she had the flu for a week and she couldn't get out of bed because her fatigue was that bad. With COVID she had started out sneezing all day and she already had a sore throat from her seasonal allergies and then it just got horrible, the sore throat did, then she had a headache, fever of 100.3, her normal is 97.5 so she felt sick but she had fatigue for 10 days to where she just laid in bed or on the couch and watched TV. She would have headache all day long and all the doctor said was to take Tylenol and Mucinex and if she got bad then she needed to go to the emergency room. You just never know when a person walks in that door because she knows a 30-year-old cop, he wasn't vaccinated, but he died in about 5 to 10 days and he was getting ready to get vaccinated. She says after COVID she had felt better for like 7 days and she had a great time then because it was labor day weekend and they had went kayaking, swimming and boating and then on 10Sep2021 she had an acute attack of viral bronchitis and went to the urgent care who said she also had oral thrush but then she went to an ENT doctor two weeks later who said that she didn't have oral thrush. They gave her a wash because she had a sore throat even though she felt fine and she thought that it was just her post nasal drip from the seasonal allergies so she had a virtual visit and was prescribed 5 days of prednisone. That made her throat better but then 2 days afterwards she had quit and it hurt just as bad as before. The doctor had prescribed her prednisone, Mucinex tablets and nystatin to swish in her mouth for the oral thrush, even though the ENT said that she didn't have that. She also had an x-ray when she first went to the urgent care and they thought that they saw a little nodule on the right side and that she had little collapsed air sacs at the bottom, they called it mild alterio bilateral (documented as provided by caller), but they were not concerned with that. Then 3 days later her cough got so bad and she had went back to urgent care because she wanted another x-ray to be sure that she didn't get pneumonia and her blood pressure there was 190/100 so they kicked her out and said to go to the emergency room because they thought that maybe she had a blood clot. She went to the emergency room and they took another x-ray and said that they saw nothing and that her lungs look totally fine. By the time she left the emergency room her blood pressure was 125/82 or something like that so they said to go home and finish her prednisone and if she didn't feel better to follow up with her primary care provider. And that's where she is and she finally got to go see the ENT again and they looked at her throat and prescribed two nasal sprays. Her post nasal drip is about 95% cleared and her throat is about 95% cleared so she is feeling good. Her question is just about getting the booster, why do they say 6 months and not any sooner. Everyone who she knows who had a breakthrough case got it within 4 to 4 1/2 months. she only takes Fosamax which she started on 01Aug2021 because her PET scan showed osteoporosis. It is the generic form that starts with "A" but it is 70 mg once a week, or 70 whatever the units are. she provided that she actually went the the urgent care on 11Aug2021 and she was negative for COVID at that time and they said that maybe she came in too soon so she went back 5 days later and that's when she was positive. she provided that she forgot to mention this but both her and her husband had lost their smell and taste. On labor day weekend she wasn't able to smell bleach and couldn't smell anything but now her taste and smell are about 95% back and her husband is starting to get his taste back but he said that everything smelt like diesel fuel and he still has not gotten his back all the way. The patient underwent lab test and procedures included blood pressure measurement: 190/100 and 125/82, Body temperature: 100.3 and 97.5, Positron emission tomogram: osteoporosis, X-ray: little nodule on the right side and on 16Aug2021, swab up her nose thing for COVID (SARS-CoV-2 test): positive. The outcome of sneezing all day, sore throat, cough was recovering and outcome of other events was unknown. No follow-up attempts were possible. No further information was expected.

Other Meds: FOSAMAX

Current Illness:

ID: 1767583
Sex: U
Age:
State: MO

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital: Y

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: body convulsions; torn muscle; subsequent muscle spasms; This is a spontaneous report from a contactable consumer (patient) A patient of unspecified age and gender received COVID-19 VACCINE ? MANUFACTURER UNKNOWN via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced body convulsions (hospitalization) on an unspecified date with outcome of unknown , torn (hospitalization) on an unspecified date with outcome of unknown , subsequent muscle spasms (hospitalization) on an unspecified date with outcome of not recovered. The clinical course was reported as follows:When I received my Pfizer J&J COVID-19 vaccination in April, I had extremely severe reactions that included full body convulsions, which resulted in a torn muscle and subsequent muscle spasms that eventually led to my hospitalization. I'm still having muscle spasms from the injury due to the convulsions caused by the vaccine. The lot number for the vaccine, [COVID-19 VACCINE], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767584
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: for my face to go numb/my arm to go numb on the side of the injection site?"; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, and Expiry Date are unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that is it normal to loose, for her face to go numb and her arm to go numb on the side of the injection site? on an unspecified date. The outcome of event was unknown. Follow-up attempts have been completed. Batch/lot number is not available for [BNT162B2]. No further Information is expected.

Other Meds:

Current Illness:

ID: 1767585
Sex: M
Age:
State:

Vax Date: 09/02/2021
Onset Date:
Rec V Date: 10/07/2021
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: he had a stroke; her husband can't drive; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: not reported, expiration date: not reported, NDC number: not reported) via an unspecified route of administration on 02Sep2021 as Dose 1, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received their second dose was unspecified. on an unspecified date, patient experienced he had a stroke and her husband can't drive. The outcome of all the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1767586
Sex: F
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: She did start getting menstrual bleeding again; I'm going through the menopause since right after 50; I'm having menstrual cycle and it's going on 3 days now; I hadn't had a period from 4 years; This is a spontaneous report from a Pfizer sponsored program reported by contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date in Apr2021 as single dose, and first dose via an unspecified route of administration on an unspecified date in Apr2021 as single dose for COVID-19 immunization. The medical history included menopause (I'm going through the menopause since right after 50). Concomitant medication included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) ongoing. The patient reported that, she had to got to take Prempro. "I'm 54 years old, I'm taking Prempro (as she was going through the menopause and had not had a period from 4 years) 45mg whatever menopausal anyway Prempro is giving me period". On an unspecified date in Sep2021, the patient experienced "she did start getting menstrual bleeding again; I'm going through the menopause since right after 50; I'm having menstrual cycle and it's going on 3 days now; I hadn't had a period from 4 years (now 54 years now)". The patient was asking "will you think that it ends or otherwise I continue to bleed." The patient was asking if she was eligible for the third dose of COVID-19 vaccine, but she also did mention that she was on Prempro. She did start getting menstrual bleeding again but she was having better sex life so that was great, but she wanted to report those AEs and then medical information regarding the third dose. The patient was told by pharmacy that she is not eligible for any third shot. Consumer hung up the call abruptly, further probing could not be done. Hence, limited information available over the call. The outcome of the event was reported as not resolved. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds: Prempro

Current Illness:

ID: 1767587
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:294 IU/l; Comments: (H); Test Date: 2021; Test Name: Paraneoplastic autoantibody panel; Test Result: Negative ; Test Date: 2021; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:149 IU/l; Comments: (H); Test Date: 2021; Test Name: Acid-fast bacteria culture in Cerebral spinal fluid; Test Result: Negative ; Test Date: 2021; Test Name: Cryptococcus Ag in Cerebral spinal fluid; Test Result: Negative ; Test Date: 2021; Test Name: Liver biopsy; Result Unstructured Data: Test Result:demonstrated high grade neuroendocrine tumor of; Comments: demonstrated high grade neuroendocrine tumor of unclear origin plus mild acute rejection in his graft prompting initiation of prednisone; Test Date: 2021; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:233 IU/l; Comments: (H); Test Date: 2021; Test Name: Total bilirubin; Test Result: 2.1 mg/dl; Comments: (H); Test Date: 2021; Test Name: Chromogranin-A; Result Unstructured Data: Test Result:403 ng/ml; Test Date: 2021; Test Name: Blood culture; Test Result: Negative ; Test Date: 2021; Test Name: IgA; Test Result: 214 mg/dl; Test Date: 2021; Test Name: IgG; Test Result: 1194 mg/dl; Test Date: 2021; Test Name: IgM; Test Result: 71 mg/dl; Test Date: 2021; Test Name: Thyroid stimulating hormone; Result Unstructured Data: Test Result:1.83 MiU/L; Test Date: 2021; Test Name: Carcinoembryonic antigen; Result Unstructured Data: Test Result:36 ng/ml; Test Date: 2021; Test Name: C-reactive protein; Test Result: 1 mg/dl; Test Date: 2021; Test Name: Glucose in Cerebral spinal fluid; Test Result: 87 mg/dl; Comments: (H); Test Date: 2021; Test Name: Protein in Cerebral spinal fluid; Test Result: 107 mg/dl; Comments: (H); Test Date: 2021; Test Name: Red blood cells in Cerebral spinal fluid; Result Unstructured Data: Test Result:2 cells/uL; Test Date: 2021; Test Name: Cerebrospinal fluid; Result Unstructured Data: Test Result:showed elevated protein without pleocytosis; Test Date: 2021; Test Name: White blood cells in Cerebral spinal fluid; Result Unstructured Data: Test Result:1 cells/uL; Test Date: 2021; Test Name: Aerobic cultures; Test Result: Negative ; Test Date: 2021; Test Name: Aerobic cultures in Cerebral spinal fluid; Test Result: Negative ; Test Date: 2021; Test Name: Urine culture; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: Cytomegalovirus; Test Result: Negative ; Test Date: 2021; Test Name: Electromyography; Result Unstructured Data: Test Result:demonstrated prolongation of lower extremity; Comments: demonstrated prolongation of lower extremity f-waves and reduced recruitment of voluntary motor units without active denervation.; Test Date: 2021; Test Name: Serum studies; Result Unstructured Data: Test Result:SPEP with few tiny oligoclonal bands in gamma; Comments: SPEP with few tiny oligoclonal bands in gamma region; Test Date: 2021; Test Name: Epstein-Barr virus; Test Result: Negative ; Test D

Allergies:

Symptom List: Unevaluable event

Symptoms: Acute Inflammatory Demyelinating Neuropathy; Guillain-Barre syndrome; This is a literature report from Liver transplantation, entitled "Guillain-Barre syndrome after COVID-19 mRNA vaccination in a liver transplant recipient with favorable treatment response". Herein, we report a case of acute inflammatory demyelinating polyneuropathy (AIDP), the most common subtype of Guillain-Barre syndrome (GBS), following initial dose of mRNA COVID-19 vaccine in an adult LTR. PATIENT CASE A 65-year-old (patient race: redacted) male with cryptogenic cirrhosis underwent an uncomplicated deceased donor liver transplant in June 2020. In February 2021, he was hospitalized for subacute lower extremity weakness and paresthesia ascending to bilateral hands over 4 days. He denied fever, cough, diarrhea, rash, sick contacts, surgery, or trauma. He had received his first dose of the Pfizer-BioNTech COVID-19 vaccine two days prior to symptom onset. Pertinent medications included cyclosporine 75mg twice daily. Medical history was notable for coronary artery disease, diabetes mellitus, and hyperlipidemia. Neurological examination on admission showed bilateral lower extremity weakness, hyporeflexia and loss of pinprick sensation. He could only stand with support and required assistance for ambulation. By hospital day 3, the patient developed bilateral cranial nerve 7 palsies. He had extensive serum and infectious studies (White blood cells 3,500/uL (L) mild monocytosis (17%) ,Platelets 89,000/uL (L),Aspartate transaminase 149 IU/L (H),Alanine aminotransferase 294 IU/L (H) ,Alkaline phosphatase 233 IU/L (H), Total bilirubin 2.1 mg/dL (H),Westergren RBC sedimentation rate 20 mm,C-reactive protein 1 mg/dL,SPEP with few tiny oligoclonal bands in gamma region,Vitamin B12 884 pg/mL,IgA 214 mg/dL, IgM 71 mg/dL, IgG 1,194 mg/dL,Thyroid stimulating hormone 1.83 mIU/L,Paraneoplastic autoantibody panel negative,Chromogranin-A 403 ng/mL (ULN <93 ng/mL),Carcinoembryonic antigen 36 ng/mL (ULN <3 ng/mL, SARS-CoV-2 negative by nasopharyngeal swab PCR,Human immunodeficiency virus negative ,Epstein-Barr virus negative ,Cytomegalovirus negative ,Fungal cultures negative,Aerobic cultures negative,Rapid plasma reagin non-reactive,QuantiFERON-TB-Gold negative,Blood culture negative,Gastrointestinal pathogen panel stool PCR negative,Urine culture,Cerebral spinal fluid studies,Red blood cells 2 cells/cmm,White blood cells 1 cell/cmm,Protein 107 mg/dL (H),Glucose 87 mg/dL (H),HSV DNA by PCR negative,Cryptococcus Ag negative ,Acid-fast bacteria culture negative ,Flow cytometry negative for atypical or malignant cells,Cytology negative for carcinoma). Brain and spine MRI were normal. Cerebrospinal fluid showed elevated protein without pleocytosis. Electromyography (EMG) demonstrated prolongation of lower extremity f-waves and reduced recruitment of voluntary motor units without active denervation. He was diagnosed clinically and electrodiagnostically with Acute Inflammatory Demyelinating Neuropathy (AIDP) and treated with intravenous immunoglobulin (IVIG). Notably, his liver enzymes were newly elevated .Liver MRI showed innumerable new bilobar lesions. Liver biopsy demonstrated high grade neuroendocrine tumor of unclear origin plus mild acute rejection in his graft prompting initiation of prednisone. The patient exhibited good response to IVIG including improvement of facial palsies and ambulation. After 2 weeks in rehabilitation, he could walk independently (Table 2). Several etiologies were considered as inciting trigger for this patient's GBS. Infectious etiology was considered given his immunocompromised state, but extensive workup was negative . A rare paraneoplastic-associated GBS was also considered but deemed unlikely given negative serology plus improvement with IVIG alone prior to any treatment of his malignancy. Ultimately, his presentation including temporal association of symptoms and progression appeared most consistent with post-COVID-19- vaccination GBS. With respect to timing of vaccination, our patient received COVID-19 vaccination 8 months after transplant so his baseline immunosuppression would less likely inhibit immunogenicity. In conclusion, our report describes a strong temporal relationship between COVID-19 vaccination and onset of neurological symptoms consistent with post-vaccination GBS. An extensive medical evaluation failed to demonstrate any infectious, malignant, or alternative precipitant. We recognize that the patient's GBS following COVID-19 vaccination is strictly correlative, and appreciate the very real challenges of defining causality of vaccination with onset of GBS.9,10 However, we feel reporting this potential association is important given current gaps in understanding of COVID-19 vaccine safety among LTR. It is also important to note the patient demonstrated good response to standard GBS treatment once the diagnosis was established. Since the overall clinical benefit gained from COVID-19 vaccination outweighs the risk of rare adverse events like post-vaccination GBS, we recommend all LTR undergo COVID-19 vaccination. Finally, transplant providers should report all potential vaccine-related adverse events to the VAERS registry.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Acute Inflammatory Demyelinating Neuropathy and Guillain-Barre syndrome and the suspect drug bnt162be 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: CYCLOSPORINE

Current Illness:

ID: 1767588
Sex: F
Age:
State:

Vax Date: 09/24/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient had the 1st dose of the Pfizer COVID 19 vaccine on 02Apr2021, She only got her 2nd dose on 24Sep2021; headache; sore arm; a little bit of nausea; This is a spontaneous report from a contactable consumer (Patient, reported for self). A 64-year-old female patient received second dose of bnt162b2 ((COMIRNATY), COVID 19 Vaccine, mRNA, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 24Sep2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had earlier received first dose of Pfizer COVID-19 vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Apr2021 (at the age of 64-year-old) and experienced miserable headache, stomach ache, nausea (mentioned that she was so sick). Patient only got her 2nd dose on 24Sep2021. On an unspecified date in Sep 2021, patient experienced headache, sore arm and a little bit of nausea. Patient reported that she thought she had to restart the series of vaccination since it had been months since she had her first dose. Vaccinator told her (not sure if pharmacist or nurse) that she is already fully vaccinated and no need to repeat the series - She was also advised to come back after 6 months for the booster, and she wanted to confirm if that was true. The clinical outcome of events was unknown The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767589
Sex: U
Age:
State:

Vax Date: 09/25/2021
Onset Date: 09/25/2021
Rec V Date: 10/07/2021
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: I had the strange side effect; lips tingling; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Sep2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Sep2021, the patient had the strange side effect, lips tingling. The patient after receiving the first dose of vaccine left the vaccination center, but they said to stay for 50 minutes. The pateint's whole family received the COVID Vaccination but only the patient had the strange side effect and was not sure if it was real or not and if anyone had complained about lips tingling right after the COVID Vaccination. The patient was not interested in filing any report, but just called to ask if it was a common side effect. The outcome of events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1767590
Sex: M
Age:
State:

Vax Date: 01/04/2021
Onset Date:
Rec V Date: 10/07/2021
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: He had an adverse reaction; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported; Expiration Date: Apr2021) via an unspecified route of administration on 04Jan2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had received the Pfizer COVID vaccine back in Jan2021 and he had an adverse reaction (Allergic reaction-hypersensitivity) on an unspecified date in 2021 and he believed that he had documented this with Pfizer on an incident report back then and he was wondering if it was possible to get any documentation on that or not. Later he confirmed that he has had no new events since his original report, he said he was pretty well within about 4 to 5 days. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767591
Sex: U
Age:
State:

Vax Date: 09/16/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:180/100 and 154/90 mmHg; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown; Test Name: CT Scan; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Name: D-Dimer test; Test Result: Positive ; Comments: My D-Dimer test came back positive

Allergies:

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

Symptoms: Hypertensive Urgency; I have sharp pains in my chest; heart was pounding out of chest; tachycardia; D-Dimer test came back positive; my headache was excruciating/head pounding; booster dose; booster dose; my blood pressure increased/My normal BP of 120/70 or 75, skyrocketed to 180/100; my body began to hurt like hell; fever; pain at the injection site; nausea; chills; my tongue and mouth tasted horrible; my lymp nodes under my left arm swole with a lump the size of a golf ball, my groin lymph nodes and even behind my knee and ankle on my left side swole.; exhausted; I felt horrible; My vision was blurry; This is a spontaneous report received from consumer (patient) in response to the query mail. A patient of unspecified age and gender received booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 16Sep2021 as dose 3 (booster), single for COVID-19 immunization. Patient decided to get the booster shot because patient donated left kidney to sister in Feb2021. Medical history for the patient included kidney donor [donated left kidney to sister in Feb2021]. Concomitant medications were none. Patient previously received dose 1 and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. On 16Sep2021, patient received booster shot of the Pfizer vaccine, within hours of receiving the vaccine, patient body began to hurt like hell on an unspecified date in Sep2021. The vaccine wreaked havoc on patient's system and one kidney obviously couldn't take it. Patient had a fever, pain at the injection site, nausea, chills, body aches, tongue and mouth tasted horrible and blood pressure increased. Over eight (8) days, post-booster, patient's lymph nodes under left arm swollen with a lump-the size of a golf ball, groin lymph nodes and even behind knee and ankle on left side were swollen, blood pressure continued to rise, headache was excruciating, patient was extremely exhausted and felt horrible on an unspecified date in Sep2021. Normal BP of 120/70 or 75, skyrocketed to 180/100. Patient went to see Primary Care Physician, both the doctor and her nurse confirmed extremely high pressure. Patient left the office and went home to rest and monitored pressure hourly and it remained high. The next day patient went to ER. Patient's vision was blurry, head pounding and blood pressure elevated but a little less than before 154/90. They ran tests, did a CT scan w/o contrast, gave a steroid, headache cocktail and sent patient home. A day later, patient still felt horrible. Now it was Friday, a full 8 days or so post vaccine and patient came back to the ER. Heart was pounding out of chest, had head aching and have sharp pains in chest. Patient was diagnosed with tachycardia and Hypertensive Urgency on an unspecified date in Sep2021. They give patient Valium and ran blood tests, and D-Dimer test came back positive. So, patient stayed in the hospital overnight for observation. Outcome of all the events were unknown.

Other Meds:

Current Illness:

ID: 1767592
Sex: M
Age:
State:

Vax Date: 05/17/2021
Onset Date:
Rec V Date: 10/07/2021
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: Test Name: Pulse Ox; Result Unstructured Data: Test Result:high 80's-low 90's; Test Name: Pulse Ox; Result Unstructured Data: Test Result:mid 90's.; Test Name: COVID; Test Result: Positive

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: tested positive for Covid; tested positive for Covid; pulse ox in to high 80's-low 90's; sick; This is a spontaneous report from a contactable pharmacist (patient's wife) via the Medical Information Team. This pharmacist reported similar events for 5 patients. This is the 5th of 5 reports. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 26Apr2021 (age at the time of vaccination was 46 years) as DOSE 1, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on 17May2021 (age at the time of vaccination was 46 years) as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested positive for covid, pulse ox in to high 80's-low 90's and sick. The reporter, her husband, and her other two daughters also tested positive for Covid. She and her husband had received both doses already but her other two daughters have not. She says this was the sickest she has been in twenty years. Reportedly, the patient was also very sick with a pulse ox in to high 80's-low 90's and still has not returned to normal. He was a marathon runner and now has a pulse ox in the mid 90's. The reporter enquired what was the optimal interval post COVID infection, to administer the second dose (ex. wait until clinical symptoms resolve vs. wait 3 more weeks vs don't exceed 6w from first dose vs do not complete series vs give ASAP regardless). On an unspecified date, the patient underwent lab tests and procedures which included Pulse Ox: high 80's-low 90's, Pulse Ox: mid 90's and COVID: positive. The outcome of the event tested positive for covid was unknown. The outcome of the event pulse ox in to high 80's-low 90's and sick was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Amendment: This Amendment report is being submitted to amend previously reported information (To update narrative leadline): This is a spontaneous report from a contactable pharmacist (patient's wife) via the Medical Information Team. This pharmacist reported similar events for 5 patients. This is the 5th of 5 reports.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event s Drug Ineffective and COVID-19 and the suspect drug bnt162b2

Other Meds:

Current Illness:

ID: 1767593
Sex: F
Age:
State: DE

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: covid-19; Result Unstructured Data: Test Result:positive; Comments: Now what about all of the vaccinated I know ALL are getting covid-19.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: all of the vaccinated I know ALL are getting covid-19; all of the vaccinated I know ALL are getting covid-19; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's 1st daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller reported that all the vaccinated people the reporter knows were getting covid-19 including reporter's two daughters and two granddaughters. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. the outcome of events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101281144 same reporter, different patient

Other Meds:

Current Illness:

ID: 1767594
Sex: U
Age:
State: CA

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Name: Various test; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: electric shock in my left size of my body like I exploded my head; dizziness; nausea; Heavy head/ head pressure; I felt weird and tired; I felt weird and tired; Stress; Fear; This is a spontaneous report from a contactable consumer. A 63-year-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EW0153), on 15Apr2021 (at the age of 50-years-old) (at the age of 63-year-old ) at single dose for COVID-19 immunization. The patient had received the first dose of BNT162B2 (Lot number: ED6204) on 25Mar2021. Medical history and concomitant drugs were unknown. The consumer reported that the second dose of vaccine for Covid 19 had second effects which she had to be in the emergency at the hospital. The patient suffered from an electric shock in the left size of the body like exploded the head, and truly the patient got scared because never experienced this in the life. This was the reason the next day the patient felt dizziness and with nauseas, heavy head, and pressure. The patient felt weird and tired, since they administered the second dose, the patient started with nauseas but the next day it was horrible that the patient ever felt in the life, that's the reason the patient went to the emergency hospital, they did various tests which the patient thought something exploded inside the head, but fortunate in the studies they did everything came out normal (according to the Doctor) because until now still feel dizzy and nauseas. Fortunate the patient had not felt the electric shock that felt before. The only thing the patient still feeling were dizzy and nausea which were daily basis. The doctor told the patient that everything was normal and go back to rest everything improved but not the dizziness and nauseas. The was in perfect condition before the vaccine and now the patient lives with stress, fear, nausea and dizziness, the patient life has totally changed. The outcome of the events was unknown. Follow-Up (05Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1767595
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: two flutter episodes in eight months; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history included COVID in Dec after which she had rate and rhythm heart issues for approximately 3 months. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. After being first Pfizer COVID vaccine, frequently and intensity of cardiovascular issues decreased. After second Pfizer vaccination the CV symptoms essentially stopped. On an unspecified date, the patient had two flutter episodes in eight months since being fully vaccinated. Event took place after use of product. The outcome of the event was unknown. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1767596
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 08/01/2021
Rec V Date: 10/07/2021
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: COVID; COVID; Felt achy; Not feeling well; This is a solicited report (FACILITATED COLLECT) from a contactable consumer (patient), based on the information received by Pfizer from Regulatory Authority (Mfr. Control No. 21K-163-4084993-00). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 1, single, and second dose intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for rheumatoid arthritis. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced COVID on Aug2021, not feeling well on 2021 and felt achy on 2021.It was reported that in 2021, the patient experienced might be not feeling well and felt achy after covid-19 vaccine. In Aug2021, the patient experienced covid. In 2021, the might be not feeling well and felt achy after covid-19 vaccine resolved. The action taken in response to the events for adalimumab was unknown. The outcome of event COVID was recovering, the other events were resolved. The reporter's assessment of the causal relationship of the reported events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment Causality for humira(adalimumab): the reporter's causality for the event(s) of might be not feeling well and felt achy after covid-19 vaccine was not provided. The reporter's causality for the event(s) of covid with humira(adalimumab) was a reasonable possibility. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective, COVID-19, pain and malaise cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 1767597
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Date: 20210902; Test Name: Covid-19 Virus Test; Test Result: Positive

Allergies:

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

Symptoms: patient contracted and tested positive; patient contracted and tested positive; had a headache for a day; This is a Non-Interventional report from Facilitated Collect based on the information received by Pfizer from Regulatory Authority (MFR Control No. 21K-163-4090044-00) from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Jan2021 (Batch/Lot number was not reported), intramuscular, and the second dose in Feb2021 (Batch/Lot number was not reported) intramuscular as single dose for covid-19 immunisation (both doses at the age of 55); upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced patient contracted and tested positive (covid-19) on 02Sep2021, had a headache for a day on Feb2021. The patient was hospitalized for patient contracted and tested positive (covid-19) for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Sep2021. The action taken in response to the event(s) for upadacitinib was unknown. Headache recovered in Feb2021. The outcome of the other events was recovering. The reporter's causality for the events COVID-19 and headache of Rinvoq (Upadacitinib): no reasonable possibility. The reporter's causality for the events COVID-19 and headache of Pfizer Biontech COVID-19 vaccine: No reasonable possibility. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Vaccination failure, Covid-19 and Headache (non-serious) and BNT162B2.

Other Meds:

Current Illness:

ID: 1767598
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: he had a family member who had vaccines and had covid; Test Result: Positive

Allergies:

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

Symptoms: He also mentioned that he had a family member who had vaccines and had covid.; He also mentioned that he had a family member who had vaccines and had covid.; This is a spontaneous report from a Pfizer-sponsored program Support from a non-contactable consumer (Family member) A patient of unspecified age and gender received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) , both on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was informed that patient experienced drug ineffective and COVID-19 infection as it was mentioned that patient ?had vaccines and had covid'. At the time of the reporting event outcome was unknown. No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

Date Died: 09/27/2021

ID: 1767599
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Breakthrough covid case after being fully vaccinated with Pfizer vaccine resulting in death from COVID; Breakthrough covid case after being fully vaccinated with Pfizer vaccine resulting in death from COVID; This is a spontaneous report from a contactable consumer (Pfizer colleague). An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 45 years (as reported) and not pregnant on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. In Sep2021, patient experienced breakthrough covid case after being fully vaccinated with Pfizer vaccine resulting in death from COVID. Covid was treated at medical center. Seriousness criteria was reported as results in death, no life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect involved. Therapeutic measures were taken as a result of the events. The patient died on 27Sep2021. Death cause was Covid. It was unknown if an autopsy was performed. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: covid; covid

Other Meds:

Current Illness:

ID: 1767600
Sex: F
Age:
State: FL

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/07/2021
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: I had an attack of angina; Pain in all muscles; Pain in all muscles and joints; could not stand or walk; could not stand or walk; Severe pain in arms and legs; Severe pain in arms and legs with swelling; body felt like patient was retaining water; This is a spontaneous report from a contactable consumer (patient). A 78-year-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 23Sep2021 09:00 (at age of 78 years old) as single dose for COVID-19 immunization. Medical history included Heart capillary deficiency, Known allergies: Yes. No COVID prior vaccination. No COVID tested post vaccination. Patient had other medications in two weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592) on 01Sep2021 10:00 AM (at age of 78 years old) at left arm as single dose for COVID-19 immunisation. On 23Sep2021 06:00 PM, the patient had pain in all muscles and joints so severe patient could not stand or walk. Severe pain in arms and legs with swelling; body felt like patient was retaining water. Patient had an attack of angina (severe), which was under treatment for. Patient had similar, but less severe problems with the first shot. Patient will not take any more COVID shots as feel symptoms will get worse and life will be in danger. AE resulted in: Life threatening illness immediate risk of death from the event. No treatment received for all other events (except attack of angina). The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1767601
Sex: F
Age:
State: VT

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 10/07/2021
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: Bruising; This is a spontaneous report from a contactable other health care professional (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EU0168 and expiration date: not reported), via intramuscular, in Left Deltoid, on 10Aug2021 (at the age of 36-year-old) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient experienced bruising on 10Aug2021. No treatment was received for the adverse event. The outcome of event was not recovered at time of report.; Sender's Comments: The event of bruising is assessed as possibly related to the suspect vaccine Comirnaty based on strong temporal association "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."

Other Meds:

Current Illness:

ID: 1767602
Sex: M
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital: Y

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: couldn't breathe at all; heart issues; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), has been sick for so many years, pulmonary distress, 100% disabled. The patient's concomitant medications were not reported. During the call caller stated her husband got his 1st shot and the next day was in the ICU struggling for his life. States he has very bad COPD and he also got the Pfizer Covid-19 vaccine Wednesday morning and by 4am Friday he couldn't breathe at all and they called 911 and he went to the hospital. States they wanted to intubate him but he knew because of his COPD he would not get off the vent so they used CPap and got him back breathing. States that such pulmonary distress has created heart issues and he is now on heart medications, he also had a reaction to the vaccine and he has very bad COPD. Caller states her husband was not going to get his 2nd shot, she is the one that wants to make sure she is somewhat better protected. States he is 100% disabled plus the COPD. Caller states her husband has been sick for so many years and she has dealt with so many health professionals for her husband that when your mind is used to this type of thinking it automatically goes there and that is where it has been since. Therapeutic measures were taken as a result of events. Emergency Room Visit and Physician Office Visit for events. The outcome of events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767604
Sex: F
Age:
State:

Vax Date: 08/25/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210915; Test Name: Nasal Swab; Test Result: Negative ; Comments: Covid test type post vaccination: Nasal swab

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Myocarditis; Fibromyalgia development; Chest pain; palpitations; Joint pain; Fatigue; Muscle aches; This is a spontaneous report from a non-contactable consumer (the patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was unknown due to misplaced/discarded) via an unspecified route of administration on 25Aug2021 08:30 at age of 24-year-old at single dose for COVID-19 immunisation. The patient had no medical history (reported as "None never"). No known allergies. The patient had no COVID prior vaccination. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. On 28Sep2021, the patient experienced myocarditis, fibromyalgia development, chest pain, palpitations, joint pain, fatigue and muscle aches. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. No treatment received for the events. COVID-19 test=Nasal Swab was taken on 15Sep2021 with negative result. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1767605
Sex: U
Age:
State: MA

Vax Date: 03/04/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210927; Test Name: PCR test; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: Lack of efficacy. Fully vaccinated for COVID19 with symptoms and confirmed positive PCR test result on 9/27/21.; Lack of efficacy. Fully vaccinated for COVID19 with symptoms and confirmed positive PCR test result on 9/27/21.; This is a spontaneous report from a contactable Pfizer colleague (Nurse) reported for a patient. A 46-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247), dose 2 via an intramuscular route of administration, administered in Arm Left on 04Mar2021 (at the age of 46-year-old) as DOSE 2, SINGLE and dose 1 via an intramuscular route of administration, administered in Arm Left on 11Feb2021 (Lot Number: EL3247), (at the age of 46-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. It was unknown prior to vaccination, the patient diagnosed with COVID-19. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Sep2021, the patient experienced COVID19. The reported stated that Lack of efficacy, fully vaccinated for COVID19 with symptoms and confirmed positive PCR test result on 27Sep2021. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures, which included PCR test: Positive on 27Sep2021, Nasal Swab. It was unknown if the patient received treatment for the events. The patient outcome of the event was unknown at the time of this report. No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2.

Other Meds:

Current Illness:

ID: 1767606
Sex: F
Age:
State:

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: Headache; She received her booster dose; She received her booster dose; She tossed and turned all night last night; This is a spontaneous report from a contactable consumer(patient). An 80-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 80 years), dose 3 via an unspecified route of administration on 28Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) as dose 2, single and first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) as dose 1, single via an unspecified route of administration on an unspecified date for covid-19 immunisation. She had no issues with the first two doses. The patient reported she tossed and turned all night last night and received her booster dose on 28Sep2021 and experienced headache on 29Sep2021. Therapeutic measures were taken as a result of headache. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767607
Sex: F
Age:
State:

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: Her Pfizer booster shot was yesterday; Her Pfizer booster shot was yesterday; felt very tired; wasn't able to sleep good; body aches; woke up with sore arm; diarrhea; vomiting; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself. A 75-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 3 via an unspecified route of administration on 28Sep2021 10:30 (at the age of 75-year-old) (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first and second dose of BNT162B2 on an unspecified date for covid-19 immunisation and experienced sore arm in both doses. Patient previously took flu shot and she just got really sick, diarrhoea and vomiting but not same time, after some time got butter just colds sweat. She also added that it also happened years ago with her mom. The patient had her Pfizer booster shot 3 on 28Sep2021 at 10:30, which was an extra dose and was exposed to an off-label scenario, and experienced body aches, diarrhoea, vomiting, felt very tired, wasn't able to sleep good and woke up with sore arm. Also stated she was unsure if maybe the side effects were really because of the booster shot or maybe there is something in your system beforehand, she would just talk to her doctor. The outcome felt very tired, wasn't able to sleep good, body aches, woke up with sore arm, diarrhea and vomiting was not recovered. The outcome of all the other events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767608
Sex: F
Age:
State: NJ

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: COVID-19; Test Result: Positive

Allergies:

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

Symptoms: having COVID-19/ I am fully vaccinated/ had a breakthrough positive case of COVID with a lot of symptoms; had a breakthrough positive case of COVID with a lot of symptoms; This is a spontaneous report from a contactable other health care professional (patient, reported for herself) via medical information team. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number: EK923), via unspecified route of administration on 11Jan2021 (at the age of 46-year-old) as a dose 2, single and patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number: EL0140), via unspecified route of administration on 21Dec2020 (at the age of 46-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history include Asthma, Sleep apnoea. The patients Concomitant medications was not reported. It was reported that reporter was an interventional radiotechnology technician but is calling as a patient. She queried if there was information regarding receiving the Pfizer-BioNTech COVID-19 Vaccine booster after receiving the Regeneron's monoclonal antibodies. She even queried for if Pfizer-BioNTech COVID-19 Vaccine booster can be given after having COVID-19 as she had a breakthrough case. It was reported that patient was fully vaccinated and on unspecified date had a breakthrough positive case of COVID with a lot of symptoms. Patient had not received any other vaccine 4 weeks prior vaccination. Product- Description (CR) COMPOUND BNT 162 COVID- 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot-# (CR): EL0140) Conclusion of Previously Completed Investigation (FCI/SI/OffCI): [Truncated Conclusion - See PR ID of Previously Completed Inv for full text] For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5515143 (see File attachment in this investigation record) The complaint for "Adverse Event Safety Request" of "PFIZER-BIONTECH COVID-19" was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot "EL0140". A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. The outcome of event was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine.

Other Meds:

Current Illness:

ID: 1767609
Sex: F
Age:
State:

Vax Date: 09/09/2021
Onset Date: 09/12/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210912; Test Name: tested positive; Test Result: Positive

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got their first dose of the Pfizer covid vaccine on 09sep2021 and tested positive on 12sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Sep2021. The outcome of the event covid-19 was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767610
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: he was down for the afternoon; This is a spontaneous report from a contactable consumer or other no-health care professional. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot: not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for covid-19 immunization. The patients medical history and concomitant medications was not reported. Patient reported that on unspecified date after the second Pfizer Covid 19 vaccine he was down for the afternoon but then he picked up. The outcome of the event was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767611
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Name: Height; Result Unstructured Data: Test Result:5'11"; Comments: shrunk from 5'11", almost 6 feet tall, to now almost 5'9"; Test Name: Weight; Result Unstructured Data: Test Result:170 lbs

Allergies:

Symptom List: Vomiting

Symptoms: heart fails; He had the lub dub in his heart and he had that after his 2nd shot; He can't remember what they call it because of his memory; his brain isn't working; in a lot of pain; This is a spontaneous report from a contactable HCP (patient himself). A 78-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose 2, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Caller said that he was laying in the hospital bed at the name withheld and after his 2nd shot he had something and he can't remember the name but it was when the heart fails or something. He couldnt remember what they call it because of his memory. He was in the hospital under their care and he also has had his third shot. He had the lub dub in his heart and he had that after his 2nd shot and he heard on the news as soon as he got home that this was a possible side effect of the shots. He couldnt think of the name of it right now but he got it and it had been with him but it started after the second shot. He didn't have a bad feeling but the nursing staff there said that it was two terms and he just can't think of it now. He was surprised because he had never had anything with his heart before. Caller stated that he was admitted inpatient at the hospital due to this. When probed for admission and discharge dates he said that was unknown to him, he was in bed and he couldnt give that information. He was in the hospital now. Clarified and confirmed that caller was currently still hospitalized. He said that he didn't know about it but he was in bed late at night and the nurse said the terms for it, it was with the chambers of the heart and it was very common but he can't think of it right now. He was in a lot of pain and laying here with all these problems. Attempted to clarify if caller was hospitalized prior to this side effect and he said that he was just laying there and they asked if he knew that he had that and he said that he had never had that happen before and it was right after his second shot. He heard on TV that some were having that with some shots. He can't remember the name of the thing with his heart. It was two of them, kind of like a lub dub but something in that area. It was common and he had heard of it many times in his life and his brain isn't working because it was full of drugs and he was just laying there. The patient underwent lab test which included body height, result: 5'11" (shrunk from 5'11", almost 6 feet tall, to now almost 5'9") and weight, result: 170 lbs on an unspecified date. The outcome of the events was unknown. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds:

Current Illness:

ID: 1767612
Sex: F
Age:
State:

Vax Date: 09/03/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: after getting her third dose; after getting her third dose; after getting her third dose she could not raise her injected arm as high as dining table; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose (BOOSTER) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FD8448), via an unspecified route of administration, administrated in left arm on 03Sep2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/ Lot Number: EM9809), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization and experienced Sore arm and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 24Feb2021, as a single dose for COVID-19 immunization and experienced Sore arm. The patient took third dose was on 03Sep2021, rash that was about 3 inches across and in a circle at the injection site, pain at the injection site in her left arm, extreme fatigue, in her left arm where she received the injection, when she bends her arm a certain way, like a 90-degree angle at the elbow, her arm locks there, left arm is immobile for a time. Added that she knows a woman that after getting her third dose she could not raise her injected arm as high as dining table on Sep2021. Asking maybe if she should have tested her antibody first before getting her third dose. As maybe if her antibody result was high, the side effect that she would. The outcome for all the events was Unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1767613
Sex: F
Age:
State: OH

Vax Date: 02/26/2021
Onset Date: 09/08/2021
Rec V Date: 10/07/2021
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: Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:slight fever; Test Date: 20210910; Test Name: covid/COVID swab; Test Result: Positive

Allergies:

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

Symptoms: she had the Delta variant; she had the Delta variant; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 26Feb2021 at around 7:30 in the morning or 8:00 in the morning (at the age of 68-year-old) as DOSE 2, SINGLE and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 68-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included cholesterol from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient's historical vaccine included flu shot in Sep2020. Prior to vaccinations (within 4 weeks), the patient had received no other vaccines. The patient had a breakthrough case in Sep2021. On 08Sep2021, the patient started to have COVID symptoms which further clarified as stuffy nose/stuffiness in nose, stuffy ears, slight fever, drainage, and sore throat. The patient also had tiredness, loose stools, and headache, stuffiness, stuffiness in nose and ears really bad. At first, the patient thought it was just sinus issue, went to the doctor and was tested for COVID. The test came back positive on 10Sep2021. The doctor informed the patient that they have been seeing breakthrough cases. The patient was assuming she had the delta variant. The patient was unsure what was happening, at first thinking it's a sinus infection. The adverse events resulted in physician office visit. The doctor was concerned that the patient was at the end of her shot period. The patient does not know how long the shot period was. The patient wanted to know if the booster shot will against the delta variant. The patient underwent lab tests and procedures which included body temperature: slight fever on 08Sep2021, covid/COVID swab: positive on 10Sep2021. The clinical outcome for the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1767614
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: Test Name: Thyroglobulin antibody; Result Unstructured Data: Test Result:3.4 IU/ml; Comments: 3.4; Test Name: Thyroid peroxidase antibody; Result Unstructured Data: Test Result:less than 0.5 IU/ml; Comments: less than 0.5; Test Name: Thyrotropin receptor antibody; Result Unstructured Data: Test Result:less than 1.10 IU/l; Comments: less than 1.10; Test Name: Thyrotropin; Result Unstructured Data: Test Result:0.009 uiU/mL; Comments: 0.009; Test Name: Thyrotropin; Result Unstructured Data: Test Result:less than 0.008 uiU/mL; Comments: less than 0.008; Test Name: Temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: febrile; Test Name: Pulse; Result Unstructured Data: Test Result:137; Comments: beats/min; Test Name: Examination; Result Unstructured Data: Test Result:revealed right thyroid gland enlargement with diff; Comments: revealed right thyroid gland enlargement with diffuse tenderness, and no proptosis, lid lag, or periorbital edema; Test Name: Thyroid stimulating immunoglobulin; Result Unstructured Data: Test Result:less than 0.10 IU/l; Comments: less than 0.10; Test Name: T4 total; Result Unstructured Data: Test Result:17.4 ug/dL; Comments: 17.4; Test Name: thyroxine (T4) free; Result Unstructured Data: Test Result:2.6 ng/dL; Comments: 2.6; Test Name: thyroxine (T4) free; Result Unstructured Data: Test Result:1.92 ng/dL; Comments: 1.92; Test Name: Triiodothyronine; Result Unstructured Data: Test Result:137 ng/dL; Comments: 137; Test Name: Thyroid ultrasound; Result Unstructured Data: Test Result:showed an asymmetrically enlarged hypervascular he; Comments: showed an asymmetrically enlarged hypervascular heterogeneous right thyroid lobe suggestive of thyroiditis

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: thyrotoxicosis; Thyroiditis; Myalgia; Fatigue; Nausea; Chills; This is a literature report from the entitled Letter to the Editor: Thyroiditis and Thyrotoxicosis After the SARS-CoV-2 mRNA Vaccine. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was reported that, rapid COVID-19 vaccine development and uptake are critical to mitigating the ongoing epidemic. Current vaccine candidates are at various stages of development and regulatory approval. These vaccines are broadly considered safe, though adverse effects have not yet been fully characterized. In this study we present the first description of thyroiditis linked to SARS-CoV-2 vaccination. It was mentioned that, no medical history received the first dose of the Pfizer-BioNTech SARS-CoV-2 vaccine 34 days before presentation, with associated fatigue, nausea, chills, and myalgias lasting 1.5 days. Patient received the second dose 13 days before presentation, and within 24 hours had recurrence of symptoms associated with new progressive anterior neck pain and swelling. Patient was referred to the hospital by out-patient provider for thyrotropin (TSH) 0.009 uU/mL, thyroxine (T4) free 2.6 ng/dL, and T4 total 17.4 mcg/dL (outpatient normal ranges [NRs] unavailable). On hospital arrival, patient was febrile to 38.3 Centigrade with a pulse of 137 beats/min. Examination revealed right thyroid gland enlargement with diffuse tenderness, and no proptosis, lid lag, or periorbital edema. Laboratories showed TSH <0.008 uU/mL (NR: 0.4-4.2), free T4 1.92 ng/dL (NR: 0.8-1.5), triiodothyronine (T3) total 137 ng/dL (NR: 87-178) with thyrotropin receptor antibody <1.10 U/L (NR: 0-1.75), thyroid stimulating immunoglobulin <0.10 U/L (NR: 0-0.55), thyroid peroxidase antibody <0.5 U/mL (NR: 0-5.6), and thyroglobulin antibody 3.4 U/mL (NR: 0-4.1). Thyroid ultrasound showed an asymmetrically enlarged hypervascular heterogeneous right thyroid lobe suggestive of thyroiditis. The patient underwent lab tests and procedures which included antithyroid antibody: 3.4 IU/ml, antithyroid antibody: less than 0.5 IU/ml, antithyroid antibody positive: less than 1.10 IU/ml, blood thyroid stimulating hormone: 0.009 uiu/ml and less than 0.008 uiu/ml, body temperature: 38.3 centigrade febrile, heart rate: 137 beats/min, physical examination: revealed right thyroid gland enlargement with diff revealed right thyroid gland enlargement with diffuse tenderness, and no proptosis, lid lag, or periorbital edema, thyroid stimulating immunoglobulin: less than 0.10 iu/l, thyroxine: 17.4 ug/dl, thyroxine free: 2.6 ng/dl and thyroxine free: 1.92 ng/dl, tri-iodothyronine: 137 ng/dl, ultrasound thyroid: showed an asymmetrically enlarged hypervascular, showed an asymmetrically enlarged hypervascular heterogeneous right thyroid lobe suggestive of thyroiditis. Patient was treated with propranolol and ibuprofen and later started on prednisone as an outpatient. The outcome of the event hyperthyroidism and thyroiditis were unknown while other events were recovered on 2021.

Other Meds:

Current Illness:

ID: 1767615
Sex: M
Age:
State: IL

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 10/07/2021
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: kidney stone/kidney stone infection; severe internal bleeding; blood clotting; bleeding; This is a spontaneous report from a contactable consumer (Consumer Husband) and also from a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 18Feb2021 as dose 2,single for COVID-19 immunization. Medical history included diabetes mellitus. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on as dose 1 ,single for COVID-19 immunization. Reporter stated her husband received his second dose of the Pfizer BioNTech Covid-19 Vaccine on 18Feb2021 and is now looking to get a booster dose of the vaccine. Reporter stated, however, that her husband had outpatient surgery for a kidney stone and ended up with severe internal bleeding (lost blood) and blood clotting. And also her husband resulted in two pints of blood on 10Aug2021. Caller asked, given the blood clots and blood transfusion, he was scheduled for the booster shot in 15 minutes and questioned if her husband can safely get a booster dose of the Pfizer BioNTech Covid-19 Vaccine and she works in the hospital and got Moderna so she is looking for information. Therapeutic measures were taken as a result of kidney stone/kidney stone infection, blood clotting, bleeding. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1767617
Sex: F
Age:
State:

Vax Date: 07/05/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: pain; Result Unstructured Data: Test Result:10

Allergies:

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

Symptoms: pain; bleeding; This is a spontaneous report received from a contactable consumer or other non hcp (patient herself) via medical information team. A 21-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 05Jul2021 as dose 2, single (at the age of 21-years-old) for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date for COVID-19 immunization. Medical history included endometriosis Treatment: BCP unspecified start date and ongoing. The patient's concomitant medications were not reported. On unspecified date of 2021 the patient experienced pain, bleeding. Patient wants to know anyone else reported these side effects and information is available regarding menstrual changes. The patient underwent lab tests and procedures which included pain: 10/10 on unspecified date. The outcome of events was unknown. The lot number for the vaccine, [Pfizer COVID-19 Vaccine], was not provided and will be requested during follow up.

Other Meds:

Current Illness: Endometriosis (Treatment: BCP)

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am