VAERS 2021 Database www.vaers.hhs.gov

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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: 1756058
Sex: F
Age:
State: NC

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 10/02/2021
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: Covid exposure; Runny nose, after booster shot; Caller started sneezing, after booster shot; Felt out of sorts, after booster shot; felt tired; Booster; off label use; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 09Sep2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced covid exposure on an unspecified date, runny nose, after booster shot on an unspecified date, caller started sneezing, after booster shot on an unspecified date, felt out of sorts, after booster shot on an unspecified date, felt tired on an unspecified date, booster on 09Sep2021, off label use on 09Sep2021. Caller stated that she was exposed from her friend, and she just wanted to relay her experience to support the booster dose. The outcome of the events exposure to sars-cov-2, rhinorrhoea, sneezing, malaise, fatigue was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1756059
Sex: F
Age:
State: VA

Vax Date: 06/29/2021
Onset Date: 06/29/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: I had uterine cramping within five minutes of administration; Then I missed my menstrual cycle for two months directly following administration.; I also developed a large painful ovarian cyst on my right ovary; This is a spontaneous report from a non-contactable consumer (Patient reported for herself). A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EU10181), via unspecified route of administration, in left arm on 29Jun2021 (at the age of 32-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 29Jun2021 the patient had uterine cramping within five minutes of administration. Then patient missed menstrual cycle for two months directly following administration. Patient also developed a large painful ovarian cyst on right ovary. The patient receives ultrasound treatment and had a physician office visit. Outcome of all the reported events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1756060
Sex: F
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 10/02/2021
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: Microembolisms on her right side blocking flow to lungs; Enlarged heart that is most likely caused by the pulmonary embolism; Pulmonary embolism; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from another Manufacturer. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 71-years-old) as dose 2, single for COVID-19 immunisation; treprostinil sodium (Batch/Lot number was not reported), nasal from an unspecified date to an unspecified date, at 18-54 mcg (3-9 breaths), qid, inhalation for secondary pulmonary (pulmonary arterial hypertension). Medical history included ongoing pulmonary arterial hypertension. Concomitant medications included apixaban (ELIQUIS) and amlodipine, both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date (at the age of 71-years-old) for COVID-19 immunisation. The patient experienced pulmonary embolism on May2021, micro embolisms on her right-side blocking flow to lungs and an enlarged heart that is most likely caused by the pulmonary embolism on an unspecified date. The clinical course was as follows: The patient reported that she had a pulmonary embolism in May. She stated that she thought it was a result of the second Pfizer Covid vaccine dose. She also had micro embolisms on her right-side blocking flow to lungs. She also had an enlarged heart that was most likely caused by the pulmonary embolism. The events pulmonary embolism and microembolism were assessed as serious and medically significant. The action taken in response to the events for TREPROSTINIL SODIUM was unknown. The 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: Based on the reported information ,a causal relationship between the events and suspected drug 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: ELIQUIS; AMLODIPINE

Current Illness: Pulmonary arterial hypertension

ID: 1756061
Sex: F
Age:
State:

Vax Date: 09/18/2021
Onset Date: 09/19/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: she was so much pain; head was sore; Joint pain; Slight fever; Feels so weak; This is spontaneous report from contactable consumer. A contactable female consumer (patient) of an unspecified age reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 18Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and When she took the first dose, she did not experience any of that. Investigation assessment was not provided. Received call from consumer regarding the Pfizer COVID Vaccine. She took the second dose on 18Sep2021 afternoon. She felt ok, but on 19Sep2021 morning, she was so much pain and her head was sore. She had joint pain, a slight fever and felt so weak also. She would like to know if she could take Tylenol for the pain. Her head was hurting her so bad and felt weak and her joints was hurting her, so she did not wish to complete report. She would contact her pharmacy, where she got the vaccine, to see if they could advise her if she could take Tylenol. The 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: 1756062
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: After the first shot, her arm hurt; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in 2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2021, after the first shot, the patient experienced pain in arm. Then, the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, in May2021, at single dose, for COVID-19 immunisation. It was confirmed that the patient was fully vaccinated with the Pfizer Covid 19 vaccine in May2021, and since then, has experienced extreme arm pain. The adverse event was described as "extreme arm pain, both arms, after both vaccinations, felt like a needle was in her arm or like she was being punched over and over again. After the first shot, her arm hurt and then she used the opposite arm for the second shot, and that probably was not a good idea". She was treated with Tylenol and Advil for the pain, but both medications were not effective to help her pain. Clinical outcome of the adverse event was unknown at time of this report. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1756063
Sex: M
Age:
State:

Vax Date: 07/09/2021
Onset Date: 07/01/2021
Rec V Date: 10/02/2021
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: Test Date: 2021; Test Name: COVID-19; Test Result: Positive

Allergies:

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

Symptoms: Tension in body; Brain fogg; Memory issues; Headache; COVID-19; COVID-19; This is a solicited report from a Non-Interventional Study based on information received by Pfizer. Solicited report by a non-contactable 31-year-old male patient with events of non-serious COVID, tension in body, brain fogg, memory issues and headache with HUMIRA (adalimumab). PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Medical history and concomitant medications were not reported. On unspecified date, patient started to receive adalimumab (HUMIRA) subcutaneous, at unspecified dose, for moderate to severe adult Crohn's disease and ankylosing spondylitis. On 09Jul2021, patient received COVID-19 Vaccine (manufactured by Pfizer/biontech, lot number and expiration date were unknown) at the age of 31-years-old as dose 1, single, for COVID-19 immunization. On an unknown date in 2021, the patient experienced COVID. Patient showed a positive SARS-CoV-2 test on unspecified date in 2021. In Jul2021, the patient experienced tension in body, brain fogg, memory issues and headache. In 2021, the tension in body, brain fogg, memory issues and headache were resolved. On an unknown date in 2021, COVID was resolved. Action taken with adalimumab was unknown. Causality for Humira (ADALIMUMAB): The reporter's causality for the event COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of tension in body, brain fogg, memory issues and headache were not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN): The reporter's causality for the event COVID-19 was not reported, while for events muscle tension, foggy feeling in head, memory impaired, and headache was possible. Change History: On 09Sep2021, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. The events of "tension in body", "brain fogg", "memory issues" and "headache" were added. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed upon receipt of follow-up information. 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: 1756064
Sex: F
Age:
State:

Vax Date: 08/23/2021
Onset Date: 08/01/2021
Rec V Date: 10/02/2021
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: Memory loss; Off label use/received third dose of BNT162B2; Extra dose administered/received third dose of BNT162B2; Rheumatoid arthritis flare up; Psoriasis; This is a solicited report received from a contactable consumer (patient) from marketing program based on the information received by Pfizer. A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular on 23Aug2021 (at 63 years old) as dose 3, single for covid-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date and ongoing, at an unknown dose and frequency (citrate free (as reported)) for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient received dose 1 of BNT162B2 on 06Apr2021 and then the second dose on 26Apr2021, both via intramuscular route as COVID-19 immunization (at the age of 63 years old). On 23Aug2021, the patient received third dose of BNT162B2 (off label use/extra dose administered). In Aug2021, the patient experienced rheumatoid arthritis flare up and psoriasis. On an unspecified date in 2021, patient had memory loss. The action taken in response to the events for bnt162b2 was not applicable, while for adalimumab was dose not changed. The outcome of the events reported was unknown. A 63-year-old contactable female consumer (patient) reported for herself that: Describe reactions (including relevant test/lab data): Memory loss- Unknown; Psoriasis- Unknown; Rheumatoid arthritis flare up- Unknown: Solicited report by a consumer of a 63 year old female with events of non-serious normal memory loss, psoriasis on feet and rheumatoid arthritis flare up with humira (adalimumab). there was no reported medical history. on an unknown date, the patient experienced normal memory loss. in august 2021,the patient experienced psoriasis on feet and rheumatoid arthritis flare up.pfizer biontech COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 6Apr2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer. On 26Apr 2021, patient received second dose COVID-19 Vaccine manufactured by Pfizer. Describe Reaction(s)(Include relevant test/lab data): On 23Aug2021, patient received booster shot COVID-19 Vaccine manufactured by Pfizer. The reporter's causality for the events of normal memory loss and rheumatoid arthritis flare up with humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of psoriasis on feet was not provided. The reporter's causality for the event of normal memory loss with BNT162B2 was not reported. The reporter's causality for the events of psoriasis on feet and rheumatoid arthritis flare up was probable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events memory loss, psoriasis on feet and rheumatoid arthritis flare up cannot be totally excluded/assessed. However, role of co-suspect humira (adalimumab) cannot be denied. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1756065
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 06/01/2021
Rec V Date: 10/02/2021
Hospital: Y

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

Lab Data: Test Name: Chest x-ray; Result Unstructured Data: Test Result:Pulmonary embolism; Test Date: 20210612; Test Name: computed tomography; Result Unstructured Data: Test Result:Pulmonary embolism; Test Date: 202106; Test Name: computed tomography scan; Result Unstructured Data: Test Result:Unknown result; Comments: done without contrast; Test Date: 202106; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210612; Test Name: Lab test; Result Unstructured Data: Test Result:Blood clot; Test Date: 20210612; Test Name: Ultrasound; Result Unstructured Data: Test Result:Pulmonary embolism; Test Date: 202106; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Shortness of breath; Chest pain; Hidradenitis suppurativa; Hidradenitis suppurativa break out at original sites/hidradenitis suppurativa flare up; Injection site stinging; Pulmonary embolism; Injection site reaction; She developed bruise on her spine after she fell.; blood clots in calves and two blood clots on each of her lower leg and one in her lung.; Pulmonary thrombosis; Thrombosis leg; Contusion of back; Fall/falling; Carotid artery occlusion; This is a solicited report from a FACILITATED COLLECT based on information received by Pfizer from Other Company. A contactable consumer (patient) reported that a 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 63-year-old), dose 2 intramuscular on an unspecified date in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation; adalimumab (HUMIRA, strength: 40MG/0.8ML, 40 Milligram, Solution for injection in pre-filled pen), subcutaneous in 2019 (Batch/Lot number was not reported), at 40 mg, 1 in 1 week for moderate to severe hidradenitis suppurativa. Medical history included three time cancer survivor, non-smoker (as reported), abstains from alcohol, spinal stenosis, degenerative disc disease, chronic obstructive pulmonary disease, had chemotherapy, radiation, lung cancer in 2007, smoker started in 2007, gastroesophageal reflux disease, carotid blockage, pain, and allergies. Concomitant medications included citalopram; pantoprazole taken for gastrooesophageal reflux disease; omeprazole taken for gastrooesophageal reflux disease; atorvastatin calcium (LIPITOR) taken for carotid artery thrombosis; oxycodone (OXYCODONE) taken for pain; and fluticasone propionate (FLONASE ALLERGY RELIEF) taken for hypersensitivity. The patient previously took ZITHROMAX IV and iodine and experienced allergy, near anaphylactic shock with iodine; and LEVAQUIN. Historical vaccine included PFIZER-BIONTECH COVID-19 VACCINE dose 1 on 15Mar2021 for COVID-19 immunisation. A 63-year-old female with events of blood clots in calves and lungs, carotid artery blockage located in shoulder near common artery, shortness of breath, pain on left chest, blood clots on each of lower leg and pulmonary embolism and non-serious fell in the bath room, recurred falling, hidradenitis suppurativa break out at original sites/hidradenitis suppurativa flare up, regular HUMIRA shot stung, bruise on back and injection site mark with HUMIRA 40MG/0.8ML (ADALIMUMAB) and HUMIRA 40MG/0.4ML (ADALIMUMAB). The patient had a relevant medical history of lung cancer, smoker, three time cancer survivor, non smoker, abstains from alcohol, iodine allergy manifested by near anaphylactic shock, spinal stenosis, degenerative disc disease, chronic obstructive pulmonary disease, had chemotherapy, had radiation, Levaquin allergy manifested by brain fog, Levaquin and zithromax allergy. On unknown dates, the patient experienced hidradenitis suppurativa break out at original sites/hidradenitis suppurativa flare up, regular HUMIRA shot stung, pulmonary embolism and injection site mark. In 2020, the patient experienced Carotid artery blockage located in shoulder near common artery. In June2021, the patient experienced fell in the bathroom and bruise on. On 12Jun2021, the patient experienced shortness of breath, pain on left chest and blood clots on each of lower leg. On 15Jun2021, the patient experienced blood clots in calves and lungs. On 16Jun2021, the patient experienced Recurred falling. On 16Jun2021, the Recurred falling resolved. In June2021, the shortness of breath, pain in left chest and fell in the bathroom resolved. On unknown dates, Hidradenitis supprativa break out at original sites/hidradenitis suppurativa flare up and injection site mark resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient was admitted in hospital on 12Jun2021 until 16Jun2021, due to shortness of breath and chest pain and said during her stay, she fell. On 15Jun2021, she was in hospital with blood clots in calves and two blood clots on each of her lower leg and one in her lung. She had pulmonary embolism. She had blood works done while in the hospital, but it was not specified. While she was in the hospital she fell in the bathroom, she thinks is was because of the strong pain medication she was receiving. She developed bruise on her spine after she fell. After went to home at night of 16Jun2021, she had an instance of falling again and could not get back up and laid on the floor for 13 hours. On 19Jun2021, she decided to go to the hospital again, as she felt she was prematurely discharged but as this time was though, she was not admitted but was sent to a nursing facility where she was being treated until 21Jun2021. She could not recall which of the laboratory tests done determined the blood clot. She clarified the carotid artery blockage was not in her neck but located in the shoulder near the common artery, and she was not admitted in the hospital due to it. She was off medication and had breakout at original sites due to blood clot. It was slowly improving since restarting medication. She had regular shot stung. She usually had injection site mark after injecting Humira. She was on unspecified blood thinners and unknown anti-depressant. The alternative etiology for blood clot was reported as Covid 19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 15Mar2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. On Apr2021, she received second dose COVID-19 Vaccine manufactured by Pfizer. On Aug2021, she received third booster dose COVID-19 Vaccine manufactured by Pfizer. Primary reporter did not have the lot number information, because the packaging was discarded. The patient was treated with XARELTO. Relevant Laboratory & Other Diagnostic Tests: Unknown date CHEST X-RAY: Pulmonary embolism ; 12Jun2021 COMPUTED TOMOGRAPHY: Pulmonary embolism ; June2021 COMPUTED TOMOGRAPHY SCAN: done without contrast - Unknown ; June2021 ECHOCARDIOGRAM: Unknown ; 12Jun2021 LAB TEST: Blood clot ; 12Jun 2021 ULTRASOUND: Pulmonary embolism ; June2021 X-RAY: Unknown. The action taken in response to the events for adalimumab was dose not changed. The outcome of shortness of breath and chest pain was recovered in Jun2021; thrombosis leg, pulmonary thrombosis, carotid artery occlusion, injection site stinging was not recovered; while outcome of fall, hidradenitis suppurativa and condition aggravated was recovered. The outcome of clot blood, pulmonary embolism, contusion of back, injection site reaction and she developed bruise on her spine after she fell was unknown. Causality for HUMIRA 40MG/0.8ML(ADALIMUMAB). The reporter's causality for the event(s) of Blood clots in calves and lungs onset 15Jun2021, Shortness of breath and pain on left chest with humira 40MG/0.8ML(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event of Carotid artery blockage located in shoulder near common artery , Hidradenitis suppurativa break out at original sites/Hidradenitis flare up, regular humira shot stung, blood clots on each lower leg, pulmonary embolism, bruise on back and injection site mark was not provided. The reporter's causality for the event(s) of Fell in the bath room and recurred falling with humira 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility. Other Company's opinion is that there is no reasonable possibility that the events of blood clots in calves and lungs onset 15Jun2021, Carotid artery blockage located in shoulder near common artery, Blood clots in calves and lungsonset 15Jun2021, Shortness of breath and pain on left chest, Fell in the bath room, recurred falling, Hidradenitis suppurativa break out at original sites/Hidradenitis suppurativa flare up, blood clots on each of lower, pulmonary embolism, bruise on back and injection site mark are related to humira 40MG/0.8ML(ADALIMUMAB). Other Company opinion is that there is a reasonable possibility that the event of regular humira shot is related to HUMIRA 40MG/0.8ML(ADALIMUMAB). Causality for HUMIRA 40MG/0.4ML(ADAL

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1756066
Sex: M
Age:
State:

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 10/02/2021
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: Ankylosing spondylitis flare up; Tendons thick/ ridged from inflammation; Tendon thickening/ Tendons thick/ ridged from inflammation; Joint stiffness; FACILITATED COLLECT This is a Solicited report based on the information received by Pfizer from Facilitating Company from a contactable male consumer reporting for himself. A 53-year-old male subject received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 01May2021 (Batch/Lot number was not reported) (at the age of 53-year-old) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date and ongoing (Batch/Lot number was not reported), at unspecified dose for ankylosing spondylitis. Medical history included surgery for spinal cord stimulator from Feb2021 and ongoing, ongoing ankylosing spondylitis. The subject's concomitant medications were not reported. The subject previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 01Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation and experienced fatigue. The subject experienced ankylosing spondylitis flare up on an unspecified date with outcome of not recovered, tendons thick/ ridged from inflammation on an unspecified date with outcome of not recovered, tendon thickening/ tendons thick/ridged from inflammation on an unspecified date with outcome of not recovered and joint stiffness on 02May2021 with outcome of unknown. The action taken in response to the events for adalimumab was dose not changed. The reporter's causality for the events tendons thick/ridged from inflammation unknown onset, tendons thick/ridged from inflammation unknown onset and ankylosing spondylitis flare up with adalimumab (HUMIRA) was a reasonable possibility. The reporter's causality for the event stiff joints with adalimumab (HUMIRA) was no reasonable possibility. The reporter's assessment of the causal relationship of the event with 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and considering drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the reported events Ankylosing spondylitis flare up, Tendonitis, Tendon thickening, and Joint stiffness cannot be completely excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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: Ankylosing spondylitis; Spinal nerve stimulator implantation (Spinal Cord Stimulator The patient had surgery for spinal cord stimulator on Feb2021.)

ID: 1756067
Sex: F
Age:
State: NJ

Vax Date: 08/31/2021
Onset Date:
Rec V Date: 10/02/2021
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 Name: blood pressure; Result Unstructured Data: Test Result:93/50; Comments: blood pressure dropped way down to 93/50; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown Results

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: They think there is a blood clot in her lung; My blood pressure dropped off to absolutely nothing; all of a sudden it down below 100 then down to in the 50's; I am not on any medication now my blood pressure is rolling good by a far; bad cough; I got the booster shot on August 31 since then all of a sudden my blood pressure dropped off to absolutely nothing; I got the booster shot on August 31 since then all of a sudden my blood pressure dropped off to absolutely nothing; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181), via an unspecified route of administration on 31Aug2021 as dose 3, single for COVID-19 immunization (at the age of 79-year-old). Medical history included ongoing high blood pressure, ongoing stage 3 kidney disease and knees replacement from 2009. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 20Jan2021 as dose 1, single for COVID-19 immunization. The patient previously also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EM9809), via an unspecified route of administration on 10Feb2021 as dose 2, single for COVID-19 immunization. The patient stated, "This probably has nothing to do with it but yet again we can't come up with anything else. She had a high blood pressure since she was 35, never changed in all those years and had basically the same medication is forever no problem. She was not on any medication now his blood pressure is rolling good by a far be best for sure. She had blood work had it half a dozen times and electrocardiogram and have another test on Tuesday and we can come up with nothing the only variation in anything that she had done would be the booster shot (COVID-19 vaccine) nothing else. They just wonder if possibly is that how some is connected, she don't know. His blood pressure would, if they doing a lot of stuff for fooling around even with the medication his blood pressure might be 185 over 95, you know probably the time it would run 135-140 down to 89 may be somewhere around like that all of a sudden it down below 100 then down to in the 50's. Received follow up for consumer regarding the third dose, booster of the Pfizer COVID vaccine. She had the booster dose on 31Aug2021. The next day, she did not feel good. From that time on, until 2-3 days ago, she had a bad cough. Within the last week or longer, her blood pressure dropped way down to 93/50. She had high blood pressure since she was 35. She quit taking medication and all that. Today, she is going for CTA test for blood clots. They think there is a blood clot in her lung. She also has to go for another heart test tomorrow and had one last Friday. Right now, they did blood work on Friday and D-Dimer test came back. It should have read 0.80 and instead read 1.83. She does not know if it is related to the vaccine, but something happened extreme. The only thing that happened that was different was the vaccine. Her primary care doctor does not even know it yet. She has been dealing with her cardiologist and nephrologist. She has to leave in 30 min to go for next test and they said they would probably put her in the hospital for next test. She did not know the name of the test that she would be hospitalized for. Her nephrologist paperwork said everything on paper except what test name is. She did not wish to provide names of the doctor's yet until she gets more information and results. She called over the weekend and she spoke with someone in Pfizer Medical Information. She does not have a report number for previous report. She thinks last digit is 1 or could be 7, but is pretty sure it is a 1. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Blood pressure high (Verbatim: High blood pressure); Kidney disorder

ID: 1756068
Sex: M
Age:
State:

Vax Date: 09/10/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
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: 20210917; Test Name: Nasal Swab; Test Result: Negative ; Comments: Nasal Swab,

Allergies:

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

Symptoms: Had a terrible cough starting 2 days after first dose. Continued to get worse and was diagnosed with pneumonia 1 week after my 1st dose; Had a terrible cough starting 2 days after first dose. Continued to get worse and was diagnosed with pneumonia 1 week after my 1st dose; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in left arm on 10Sep2021 12:30 (at the age of 25-years-old) as dose 1, single for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient experienced a terrible cough starting 2 days after first dose which continued to get worse and was diagnosed with pneumonia 1 week after first dose in Sep2021. The patient underwent lab tests and procedures which included Nasal swab: negative on 17Sep2021. Therapeutic measures taken as a result of the events included antibiotics. The outcome of all events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1756069
Sex: F
Age:
State:

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: fainting sensation but she didn't pass out; fainting sensation/dizziness; flushing; numbing sensation on her jaw; tingling; weakness; jaw became heavy for a short time; experienced sore arms; This is a spontaneous report from a Contactable Nurse (patient).A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Aug2021 (Batch/Lot number was not reported) (at the age 46-years-old) as dose 1, single for covid-19 immunization. Medical history and concomitant were none. The patient was healthy person. On 14Aug2021, the patient experienced fainting, dizziness, flushing, numbness facial, tingling, weakness, tightness in jaw and pain in arm. The patient reported that she experienced side effects after getting the first dose last 14Aug2021. She specified she had it at the moment while on site. She experienced dizziness, had a fainting sensation but did not actually pass out, flushing, numbing sensation on her jaw, tingling all over the body but most especially on her jaw, jaw became heavy for a short time, and had sore arms. She mentioned that those that she mentioned did not last as she was able to walk out of the establishment. She added that she still experienced overall weakness after she left the vaccination site and a mild tingling sensation for 24 hours. The overall weakness and the mild tingling sensation only lasted for 24 hours that then they both went away, she does not have any side effects to now. The tingling sensation for the most part was kind of mild and she would say that the flushing was moderate because she felt like she had been standing under the sun for hours. The Causality reported as all related because they happened right after the vaccine. On 14Aug2021, the patient recovered from fainting, dizziness, flushing, numbness facial, tightness in jaw, pain in arm and on 15Aug2021, the patient recovered from tingling and weakness. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Syncope, Dizziness, Flushing, Hypoaesthesia, Paraesthesia, Asthenia, muscle tightness, Pain in extremity and suspect drug 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:

Current Illness:

ID: 1756070
Sex: F
Age:
State: TX

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 10/02/2021
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: 20210823; Test Name: Hearing; Result Unstructured Data: Test Result:Cleared all good; Test Date: 20210725; Test Name: Blood work; Result Unstructured Data: Test Result:High WBC; Test Date: 20210731; Test Name: Blood work; Result Unstructured Data: Test Result:WBC was higher; Test Date: 202101; Test Name: Stress test; Result Unstructured Data: Test Result:Everything great; Test Date: 20210725; Test Name: CT Scan; Result Unstructured Data: Test Result:Good; Test Date: 20210727; Test Name: CT Scan; Result Unstructured Data: Test Result:Everything looks ok; Test Date: 20210725; Test Name: ECG; Result Unstructured Data: Test Result:Good; Test Date: 20210902; Test Name: ECG; Result Unstructured Data: Test Result:Good; Comments: wear a Heart monitor; Test Date: 20210826; Test Name: EEG; Result Unstructured Data: Test Result:Good; Test Date: 20210902; Test Name: Investigation; Result Unstructured Data: Test Result:Still doing; Comments: Heart monitor; Test Date: 20210723; Test Name: MRI; Result Unstructured Data: Test Result:Good; Test Date: 20210727; Test Name: MRI; Result Unstructured Data: Test Result:Everything looks ok; Test Date: 20210731; Test Name: monocytes; Result Unstructured Data: Test Result:High; Test Date: 20210731; Test Name: absolute neutrophils; Result Unstructured Data: Test Result:Unknown results; Test Name: Physical; Result Unstructured Data: Test Result:Unknown results; Comments: Yearly Physical done; Test Date: 20210731; Test Name: platelet count; Result Unstructured Data: Test Result:High

Allergies:

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

Symptoms: ulcerative colitis; nerve damage from vaccine; ulcerative colitis; stress; always been regular but not since the shot; She didn't have cramps during it, but after her period has ended; mestrual cycle has been different; dizzy; platelet count high; monocytes high; absolute neutrophils high; fainted; high white blood count; something happened to my nerves with the vaccine; jolt down left leg, foot off and on numb; tingling nerve mainly down left leg but also off/ on in body; my eye lids both twitch off and on; Pressure in head on right side started right away after shot; extremely sensitive to heat outside/bad heat sensitivity; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Number: EW0175 and expiration date was not reported), intramuscular, administered in Arm Right on 08Jul2021 (at the age of 42-years-old) at dose 2, single for covid-19 immunization. Medical history included colitis ulcerative from 2005 and ongoing, had benign tumor removed from breast (Left) and was cleared all done; breast biopsy on 27Apr2021- breast extension biopsy surgery to remove tumor and tumor ended up being benign, arachoid cyst between cerebellum but told most likely born with it and also had bad anxiety. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot Number was EW0175, and expiration date were not reported), intramuscular, administered in Arm Right on 16Jun2021 at dose 1, single for covid-19 immunization and experienced pressure on right side of head. The most recent vaccine was administered at Doctor's office/Urgent Care. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jul2021 after second shot, patient experienced pressure in head on right side started right away after shot and right eye lid twitched all day after shot. On 19Jul2021, she had tingling Off and on numbness down the left leg and foot. On 20Jul2021 patient saw a doctor for everything and told to take Prednisone 20mg after MRI. On 23Jul2021, MRI was done, and results showed everything was okay. There was an arachoid cyst between cerebellum but told most likely born with it. On 25Jul2021, patient fainted outside around 12:30pm went to ER. She felt extremely sensitive to heat since shot and it has not gone away. On 25Jul2021, ECG, Blood work and CT Scan has been done. CT scan showed everything was okay. Blood work had high white blood count but most likely due to 3 days on Prednisone or possible vaccine doing its thing. She stopped taking Prednisone after that day. On 27Jul2021, she went to Neurologist and looked at MRI and CT scan and was said everything looks okay. She believed something happened to her nerves with the vaccine. She was prescribed Gabapentin 100mg to take at night and did EEG study and started taking Gabapentin 100mg 3xday. On 31Jul2021, she had another set of blood lab done because Prednisone should be out of her system. Her white blood count was higher then at ER, Absolute Neutrophils, Absolute Monocytes high, and Platelet count high too. Spoke with PCP and she said to just redo labs 6 weeks out from having vaccine to make sure vaccine out of her system. If it was still high, then she would be referred to blood specialist. She stated that her ulcerative colitis (UC) was acting up but most likely due to stress of everything going on. She was working with GI doctor to figure out what was going on. On 11Aug2021, PCP gave Z pack and it helped with some UC a bit but not to head stuff or nerve stuff. On 11Aug2021 she saw nurse Practitioner at another location for opinion because dizzy spells were getting bad. She showed her something to adjust crystals in ear and told to wear apple watch to watch heart rate. She was given a few xanax medication to take when she had bad anxiety. And also given Flonase and patient tried it twice and dizziness got stopped. She said she should see a cardiologist and ENT. Patient started epson salt baths a few times a week. On 19Aug2021 patient saw PCP to touch base and was given vertigo medicine but it didn't work and said would call in Klonopin as needed (not taking Xanax any longer). Patient was told not to take gabapentin and klonopin at same time. On 23Aug2021, she saw ENT and was told that everything in ears looked good and had good hearing too and was told to go for further testing for inner ear but probably would be okay if she didn't. Hear monitor on 02Sep2021- placed for 2 weeks ENT: Ear hearing checked for post inner ear stuff and results showed cleared all good. She said she should see a cardiologist. On 24Aug2021, patient saw eye doctor for yearly appointment, and he said everything was okay with eyes, but patient was not sure why she was having twitching. On 26Aug2021, she had EEG and results came back good. On 02Sep2021, patient went to cardiologist and he said it sounded like she had nerve damage from vaccine possibly and did ECG and was having her wear a heart monitor for 2 weeks and was scheduled for heart ECHO on 28Sep2021. On 08Sep2021, patient saw PCP to see if it was better and to go over everything she has done in last visit. Patient was referred to new Neurologist since previous doctor left practice. On 09Sep2021 Currently, patient was taking Gabapentin 2-3 a day and Klonopin usually every other day but still have pressure in right side of head (not a headache) it was like someone pushing on her head. She was extremely sensitive now to heat outside. get lightheaded and dizzy if it was warm outside. Her eye lids both twitched off and on during the day. She felt tingling throughout her body during the day. Her foot numbness has gotten better but it still comes and goes. Patient's menstrual cycle has been different since the vaccine and it was started early and not as heavy. She didn't have cramps during it, but after her period has ended. She has always been regular but not since the shot. She had an appointment with a doctor in November who was specializing in Covid long haul and even thought to never had it. His staff said she has qualified since having so many of the same symptoms occurred from the shot. Scheduled to have blood labs done again next week at the time of report. Yearly physical test was done on 30Dec2021 and all labs were great then. In Jan2021, she had stress test and they said everything great. The events (tingling/numbness in left foot off and on, eye lids both twitch off and on, Pressure in head on right side) resulted in physician office visit; fainted resulted in emergency room visit. The outcome of the events platelet counts high, monocytes high, absolute neutrophils high, high white blood count, something happened to my nerves nerve damage from vaccine and stress was unknown while rest events were not recovered. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021900657 Same reporter/ patient, different dose/similar events

Other Meds:

Current Illness: Ulcerative colitis

ID: 1756072
Sex: F
Age:
State: NY

Vax Date: 09/10/2021
Onset Date: 09/13/2021
Rec V Date: 10/02/2021
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: hives; This is a spontaneous report from a contactable pharmacist. A 24-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 10Sep2021 (at the age of 24-years-old) (Batch/Lot Number: FD0809) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included irritable bowel syndrome. The patient's concomitant medications were not reported. On 13Sep2021, the patient experienced hives (medically significant). The Hives were noticed to be first experienced on the torso on Monday 13Sep2021. The Xifaxan was started on 17Sep2021. On an unspecified date, irritable bowel syndrome disorder. The outcome of the events was unknown.; Sender's Comments: Based on the temporal relation, the association between the event of Urticaria and the suspect product of BNT162B2 cannot be completely ruled out. 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: 1756073
Sex: M
Age:
State: CA

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 10/02/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: headache; high blood pressure; administered a non-diluted version of vaccine, injected him with 6 times of the medically recommended amount of the vaccine; administered a non-diluted version of vaccine, injected him with 6 times of the medically recommended amount of the vaccine; administered a non-diluted version of vaccine, injected him with 6 times of the medically recommended amount of the vaccine; This is a spontaneous report from a contactable lawyer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 22Aug2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was administered with a non-diluted version of vaccine, injected him with 6 times of the medically recommended amount of the vaccine on 22Aug2021. As a result of improper injection, patient was hospitalized with high blood pressure, headaches, and other such extreme side effect. The reporter stated that this will hereafter be referred to as the incident. Outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1756074
Sex: F
Age:
State: MD

Vax Date: 04/24/2021
Onset Date: 05/14/2021
Rec V Date: 10/02/2021
Hospital: Y

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

Lab Data: Test Date: 20210514; Test Name: COVID -19; Test Result: Positive ; Comments: covid test positive; Test Date: 202106; Test Name: COVID -19; Test Result: Negative ; Comments: covid test negative; Test Date: 202107; Test Name: COVID -19; Test Result: Negative ; Comments: covid test negative; Test Date: 202108; Test Name: COVID -19; Test Result: Negative ; Comments: covid test negative

Allergies:

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

Symptoms: Reports that she initially got her first Pfizer Covid vaccine dose on April 24th but afterwards got Covid and was hospitalized; Reports that she initially got her first Pfizer Covid vaccine dose on April 24th but afterwards got Covid and was hospitalized; has kidney issues/ Covid it attacked her kidneys; She tested positive for Covid it attacked her kidneys and put her into Type 2 diabetes; She lost 44 pounds.; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old female patient received first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171, Expiration date: unknown), via an unspecified route of administration in Arm Left on 24Apr2021 at 10:00 (age at time of vaccination was 55-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The reporter stated patient initially got her first Pfizer Covid vaccine dose on 24Apr2021 but afterwards got COVID positive on 14May2021 and had to quarantine in the hospital. she was admitted on 21May2021 and discharged on 27May2021. The patient recovered fully and everything and moving forward she would go every month to get tests, she underwent lab test in Jun2021, Jul2021 and Aug2021, that the patient was tested for COVID and all the tests shown negative. The patient was on her way to get the 2nd COVID shot on 15May2021 and when she tested positive for COVID it attacked her kidneys and put her into Type 2 diabetes and she was working with her doctor to get back to good health with her kidneys. The patient also lost 44 pounds. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14May2021 resuls in covid test positive ,sars-cov-2 test: negative on Jun2021 resulted covid test negative ,sars-cov-2 test: negative on Jul2021 resulted covid test negative , sars-cov-2 test: negative on Aug2021 covid resulted test negative. The outcome of the event COVID-19 was recovered, Type 2 diabetes mellitus was not recovered and other events was unknown. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756075
Sex: F
Age:
State: KY

Vax Date: 05/05/2021
Onset Date: 05/06/2021
Rec V Date: 10/02/2021
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 Date: 20210506; Test Name: crp; Result Unstructured Data: Test Result:Elevated; Comments: elevated sed rate and crp.; Test Date: 20210506; Test Name: sed rate; Result Unstructured Data: Test Result:Elevated; Comments: elevated sed rate and crp.

Allergies:

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

Symptoms: prolonged palpatations; tachycardia; SOA; sweats; fevers; anxiety; abdominal pain; lymphadenopathy axialla; elevated sed rate and crp; elevated sed rate and crp; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration on 05May2021 (at the age of 31-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date (at the age of 31-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had prolonged palpitations, tachycardia, shortness of air (SOA), sweats ,fevers, anxiety, abdominal pain lymphadenopathy axilla, elevated erythrocyte sedimentation rate and C-reactive protein (CRP) on 06May2021. These events were lasting for 2 to 3 months without other explanation with extensive workup basically a prolonged immune response to the vaccine. These events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment with beta-blockers for palpitations and tachycardia and had a close monitoring with extensive work ups. This case was considered as serious but not specified. The outcome of the events was recovering at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1756076
Sex: F
Age:
State: CA

Vax Date: 08/24/2021
Onset Date: 08/01/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: Covid testing; Result Unstructured Data: Test Result:Posiive

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: but she did not go; couldn't wake up; heart problems; breathing problems; vomiting; headaches; weight it either 110 or 120 pounds since she has been on steroids last month; Had suffered stomach issues and ended up getting diarrhea and is doing good with the stomach; got covid from grandson drinking out of her cup; doctor ordered a Covid test and it came back positive; didn't go to the emergency room because she kept falling asleep; Was still really sick from the vaccine; only had body pain; Ended up with Covid a week later; Ended up with Covid a week later; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program from medical information team. A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0178) intramuscular at left arm on 24Aug2021 at 11:00 am (at the age of 42-years-old) as dose 1, single for covid-19 immunization. The patient's medical history included enlarged heart, inflammation disorder, ulcerative colitis, irritable bowel syndrome (IBD), and heart trouble, autoimmune disorder from an unknown date and unknown if ongoing as she had been hit by a car, had surgery 10 years ago on an unknown date. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Does not like taking medicines very much, stays away from taking anything. Has taken antibiotics once and had no reaction. Can take Ibuprofen and Nothiscle without any serious reactions. The patient's concomitant medications were not reported. The patient was ended up with Covid a week later, weight it either 110 or 120 pounds since she has been on steroids last month, had suffered stomach issues and ended up getting diarrhea and is doing good with the stomach, got covid from grandson drinking out of her cup; doctor ordered a Covid test and it came back positive, didn't go to the emergency room because she kept falling asleep, was still really sick from the vaccine, had body pain on Aug2021, but she did not go; couldn't wake up, heart problems, breathing problems, vomiting, headache on 24Aug2021. The patient taking Covid 19 vaccine because of job would fire her if she did not get it. She received the first Covid vaccine and had heart problems and breathing problems the first day. Had vomiting as well. Her doctor told her to go to the Emergency room, but she did not go. The patient is having minor issues with her heart and it's been about a month since she received the vaccine and is wondering how long they might last. Got a headache a month since receiving the vaccine and wonders if that was reported. States it's been 3 weeks, almost a month and she is still having issues. Is going to see a heart doctor to check out her heart to see if it. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The adverse event resulted to attend the Physician Office. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse event following prior vaccinations was none. Family Medical History Relevant to adverse event was none. The patient had a positive test for SARS-CoV2. The patient have SARS-CoV2 antibodies at diagnosis was unknown whether IgM /IgG or both. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit. The patient required supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation was unknown. The patient had provided information on any new or worsened symptoms/signs during the COVID-19 illness experienced (including date of onset/worsening) had cardiovascular still has heart problems and pain. The patient did not received any additional therapies for COVID-19. The event did not required the initiation of new medication or other treatment or procedure. The patient relevant medical test included covid test was positive on Sep2021. The outcome of the event Covid-19 was recovering, but she did not go; couldn't wake up, weight it either 110 or 120 pounds since she has been on steroids last month, got covid from grandson drinking out of her cup; doctor ordered a Covid test and it came back positive, didn't go to the emergency room because she kept falling asleep, was still really sick from the vaccine and had body pain was unknown, vomiting was recovered on an unknown date and the outcome of the other events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756077
Sex: F
Age:
State: NY

Vax Date: 03/28/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 2020; Test Name: Vitamin D deficiency; Result Unstructured Data: Test Result:16

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: has an autoimmune condition of her skin and a flare up of the condition; has an autoimmune condition of her skin and a flare up of the condition; has an autoimmune condition of her skin and a flare up of the condition; This is a spontaneous report from a contactable consumer (parent). A 38-year-old (also the age at vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 28Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included vitamin D deficiency diagnosed last year (2020) and ongoing which her level was 16. She also had ongoing autoimmune skin disorder which she used to having flare up and initially received DUPLICIT (as reported) and tried other antibiotics which nothing seems to work. She also mentioned that got large lymph nodes because of her skin condition (ongoing), had breast cancer and a carcinoid tumor in left lung which she had radiation and chemo a while ago prior to COVID shots. The patient also had birth control as she doesn't get her period every month, sores in her mouth due to acne medicine and iron deficiency. Concomitant medications included ustekinumab (STELARA) taken for autoimmune skin disorder from an unspecified start date to Aug2021 and unspecified birth control. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 07Mar2021 (Batch/Lot number was not reported) at the age of 38-year-old as for COVID-19 immunization. Then, received the 2nd dose on 28Mar2021. A couple weeks after, she had a mild flare up of the condition (has an autoimmune condition of her skin). The flare up that doesn't seem to be going away which her doctor give her steroids because she's not sleeping due to the flare up. Outcome of the events were not recovered. Information on the lot/batch number has been requested.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness: Autoimmune disorder (used to having flare up); Lymphadenopathy (because of her skin condition); Skin disorder (used to having flare up); Vitamin D deficiency (Diagnosed last year (Her level is 16))

ID: 1756078
Sex: M
Age:
State: OH

Vax Date: 09/13/2021
Onset Date: 09/19/2021
Rec V Date: 10/02/2021
Hospital: Y

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: Patient developed documented endocarditis on day 7 post administration; This is a spontaneous report from a contactable pharmacist. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 intramuscular, administered in left arm on 13Sep2021 (Batch/Lot Number: EC0179) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on an unspecified date (Batch/Lot Number: EC0179) as dose 2, single for COVID-19 immunisation. The patient experienced patient developed documented endocarditis on day 7 post administration on 19Sep2021. The event led to hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient been tested for COVID-19. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of endocarditis cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1756079
Sex: F
Age:
State: CO

Vax Date: 09/01/2021
Onset Date: 09/02/2021
Rec V Date: 10/02/2021
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: Minor flu like symptoms; Low-grade fever; Headache; Fatigue; Muscle weakness in my right hand and arm; Swelling in my right foot; I have a neuromuscular disease that affects the right side of my body, and the vaccine seems to have made the disease worse; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Sep2021 14:30 (at the age of 41-year-old) (Lot Number: EW0167) as dose 2, single for COVID-19 immunization. Medical history included unknown neuromuscular disease - possibly Charcot Marie tooth or a rare form of muscular dystrophy. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included lysine (LYSINE) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop dates were not reported. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Aug2021 14:00 (at the age of 41-year-old) (Lot Number: EW0167) as dose 1, single for COVID-19 immunization. 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 and since the vaccination, the patient has not been tested for COVID-19. On 02Sep2021 14:00, the patient had had minor flu like symptoms including low-grade fever, headache, fatigue. The most concerning side effects as reported by the patient were a daily headache that does not respond to OTC pain meds, muscle weakness in her right hand and arm, and swelling in her right foot. The patient had a neuromuscular disease that affects the right side of her body, and the vaccine seemed to have made the disease worse. The patient received treatment for the events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: LYSINE; ALLEGRA

Current Illness:

ID: 1756080
Sex: F
Age:
State:

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Very very severe menstrual cramping, heavy bleeding with clots.; Very very severe menstrual cramping; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 17Sep2021 at 11:30 AM (Batch/Lot number was not reported) (at the age of 54-year-old) as dose 1, single for COVID-19 immunization. Facility type vaccine was pharmacy or drug store. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant. The patient's medical history included allergies to penicillin and shellfish. Concomitant medications included estradiol, progesterone (PROGESTIN), ascorbic acid (VITAMIN C), vitamin D NOS (VITAMIN D), and probiotic; all taken for unspecified indications, start and stop dates were not reported. On 18Sep2021 18:00 (06:00 PM), the patient experienced very very severe menstrual cramping, heavy bleeding with clots. The patient was not tested for COVID post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds: ESTRADIOL; PROGESTIN; VITAMIN C [ASCORBIC ACID]; VITAMIN D

Current Illness:

ID: 1756081
Sex: U
Age:
State: GA

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 10/02/2021
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: extensive testing; Result Unstructured Data: Test Result:no other cause; Comments: Testing tied the shot directly to the stroke

Allergies:

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

Symptoms: stroke; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. The patient experienced stroke 17 hours later of vaccination of second dose, on an unknown date in Feb2021. The patient went through extensive testing which revealed no other cause, tied the shot directly to the stroke. The patient also reported that on 05Jan2021, the patient was extensive and perfect physical. It was also reported that the patient recovered somewhat but will have to live with symptoms for a lifetime. The outcome was recovered with sequel for the reported event. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1756082
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: angioedema; welts/hives; random swelling over different areas; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on an unknown date for Covid-19 immunisation. Concomitant medication included adalimumab (HUMIRA) taken for immune suppressed, start and stop date were not reported. The patient reported that since receiving the second dose of the vaccine, he/she developed angioedema on an unspecified date and believed to be caused by the vaccine. Patient also had welts/hives and random swelling over different areas on an unspecified date. The symptoms were somewhat under control with a Claritin once a day. Patient was on Humira therefore immune suppressed. Although patient take steroids when having flare, he/she takes steroids and rest. Patient was prescribed Epi pens as well as a precaution. Outcome of the events was unknown.

Other Meds: HUMIRA

Current Illness:

ID: 1756083
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: COVID-19; COVID-19; FACILITATED COLLECT This is a solicited report based on information received by Pfizer from a Facilitating Company. A contactable consumer (patient) reported that a 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), intramuscular on an unspecified date as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose (reported as CF) for moderate to severe hidradenitis suppurativa. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced COVID-19. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of the events was not recovered. Causality of COVID-19 and adalimumab as per reporter (Drug/Vaccine) was not reported. Causuality of COVID-19 and BNT162B2 as per reporter (Drug/Vaccine) was Possible. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of event covid19 and drug ineffective cannot be totally excluded.

Other Meds:

Current Illness:

ID: 1756084
Sex: U
Age:
State: NJ

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: balance problems where I have to hold on to walls, door knobs, or any fixed item; nausea; I my THIRD Booster Covid Vaccine; I my THIRD Booster Covid Vaccine; the shoulder was sore; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Sep2021 (Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. Medical history included crohn's disease for 52 years. The patient's concomitant medications were not reported. Immediately after third booster covid vaccine on 08Sep2021, patient's left arm at the shoulder was sore and no problem. But, after 5 days on 13Sep2021 and continuing to date of 19Sep2021, when patient got up in the morning (slowly), patient had balance problems where patient had to hold on to walls, doorknobs, or any fixed item to hold on to, to get to the bathroom. At the same time, patient had bad nausea which continues for hours, or until a 20mg Nausea Pill was taken as a treatment. The outcome of all events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1756085
Sex: F
Age:
State: NJ

Vax Date: 02/13/2021
Onset Date: 02/21/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: I haven't had menstrual cramps since I have been a teenager. These have been entry month since the shot.; This is a spontaneous report from a contactable consumer. This 46-Year-old female consumer (patient) reported that: A 46-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection; Lot Number: EN5318), via an unspecified route of administration, administered in left arm as dose 2, single on 13Feb2021 13:00 (at the age of 45-year-old) for COVID-19 immunization at Pharmacy. Patient had no medical history and had no known allergies. Historical vaccine included patient previously took first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection; Lot Number: EL3246), via an unspecified route of administration, administered in left arm as dose 1, single on 14Jan2021 13:45 (at the age of 45-year-old) for covid-19 immunisation. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]); vitamin D nos (VITAMIN D NOS); vitamin B nos (VITAMIN B NOS) and bupropion hydrochloride (WELLBUTRIN) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received any other medications with Vitamin E, D and B. Wellbutrin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 21Feb2021 14:00, the patient had severe menstrual cramps and didn't have menstrual cramps since she was a teenager. These have been entry month since the shot. No treatment was received for the adverse events. At the time of this report, the outcome of event was unknown. Follow-Up (23Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1756086
Sex: F
Age:
State: MN

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Bell's Palsy symptoms; Right sided facial paralysis; Inability to close the right eye; Right sided facial numbness; Lop-sided smile; Patient received Pfizer COVID vaccine 01Mar2021,15Mar2021; This is a spontaneous report from a contactable Nurse. A 45-year-old female patient received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for COVID-19 immunization and received POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on 26Jul2021. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 on 01Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. On 30Jul2021, patient experienced Bells Palsy symptoms, right sided facial paralysis, inability to close the right eye, right sided facial numbness, and lop-sided smile. The patient was treated with Valacyclovir 1000mg TID for 5 days, and Medrol dose pack 4 mg X 6 days. The outcome of event Inappropriate schedule of vaccine administered was unknown and for other events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the event bells palsy and facial paralysis and the suspect drug BNT162B2 cannot be ruled out. 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: 1756087
Sex: U
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: EEG's; Result Unstructured Data: Test Result:ruled out brain tumors, spots, etc.; Test Name: MRI's; Result Unstructured Data: Test Result:ruled out brain tumors, spots, etc.

Allergies:

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

Symptoms: seizures; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient just wanted to make sure that severe side effect was reported to you. Patient knew it was reported to VAERS but could not seem to find it anywhere. Patient had seizures since the day after second dose on an unspecified date. The patient underwent lab tests and procedures which included electroencephalogram (EEG): ruled out brain tumors, spots, etc., magnetic resonance imaging (MRI): ruled out brain tumors, spots, etc. The neurologists had ruled out brain tumors, spots, etc. with MRI's, EEG's, and a stay in the emergency multidisciplinary units (EMU) at a hospital. 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: 1756088
Sex: M
Age:
State: CO

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: developed hearing loss in his right ear; This is a spontaneous report from a contactable consumer (patient's parent). A 15-year-old male patient (reporter's son) received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: 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. Reporter's family and reporter had all been vaccinated with BNT162B2, about 6 to 7 weeks later reporter's son who was a healthy 15-year-old developed hearing loss in his right ear. Reporter had sent him to an ear, nose, and throat (ENT), he was on steroids medication, but he still had not recovered the doctors could not figure out why he lost his hearing. Reporter had spoken to several others who have lost their hearing after testing positive with COVID. Reporter liked to speak with someone regarding a connection. Therapeutic measures were taken as a result of event and included treatment with steroids. The outcome of event was not recovered. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1756089
Sex: F
Age:
State: MN

Vax Date: 09/15/2021
Onset Date: 09/19/2021
Rec V Date: 10/02/2021
Hospital: Y

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

Lab Data: Test Name: CT; Result Unstructured Data: Test Result:Unknown; Test Name: EEG; Result Unstructured Data: Test Result:Unknown; Test Name: MRI; Result Unstructured Data: Test Result:Unknown; Test Date: 20210919; Test Name: Pcr; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Injection site pain

Symptoms: Stroke like symptoms and seizures. Hospitalized 2 days; Stroke like symptoms and seizures. Hospitalized 2 days; This is a spontaneous report from a contactable Nurse (patient). A 50-years-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Right on 15Sep2021 09:00 (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. Medical history included cross sensitivity reaction from an unknown date and unknown if ongoing. The patient was taking an unspecified concomitant medications. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination. On 19Sep2021 15:00, patient had Stroke like symptoms and seizures. Hospitalized 2 days. On 19Sep2021 patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) and computerised tomogram, electroencephalogram, magnetic resonance imaging on an unknown date with unknown results. Therapeutic measures were taken as a result of seizures, stroke like symptoms. The patient visited Emergency room and Physician office. The clinical outcome of the events were not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As per the information in the case provided, the causal association between the events Seizures and Cerebrovascular accident and the suspect drug bnt162b2 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: 1756090
Sex: F
Age:
State: MS

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hot flashes; night sweats; extremely heavy menstrual periods; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 02Apr2021 13:00 (Batch/Lot Number: ER8733) as dose 2, single (age at vaccination 37-year-old) for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on Mar2021, administration site (Left arm), administered at 01:00 PM (age at vaccination 37-year-old), lot number EN6204 for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. The patient was not pregnant at the time of vaccination. On 02Apr2021, the patient experienced hot flashes, night sweats, extremely heavy menstrual periods. Adverse event: New gynecological symptoms: hot flashes, night sweats, extremely heavy menstrual periods. Patient did not received treatment for events.The outcome for all events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756091
Sex: F
Age:
State: IN

Vax Date: 09/20/2021
Onset Date: 09/21/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: but now my whole neck is swollen.; like I was wrapped in million blanket and taking tons of hand gloves and then breaking out into giant sweat.; I had severe chills like Tuesday it was really bad; My neck is like super swollen like my lymph node.; I started getting like the arm that''s whatever I know your arm is going to hurt; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 36-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration, administered in Arm Left on 20Sep2021 17:00 (Age at vaccination: 36-years-old) as dose 2, single for covid-19 immunization. (Vaccination facility: pharmacy). Medical history was reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (Age at vaccination: 36-years-old) for covid-19 immunization. It was reported that patient god second dose and next day she started getting like the arm that whatever she know your arm is going to hurt but now her whole neck is swollen and she had severe chills like Tuesday it was really bad like she was wrapped in million blanket and taking tons of hand gloves and then breaking out into giant sweat now on her neck is like super swollen like her lymph node like they think they are and she just do not know what do. Wait or to go way. Wanted to ask Is that normal Or have to make doctor appointment. Patient did not done any lab test. The outcome for the event was reported as unknown at the time of this report. Follow-Up (01Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756092
Sex: F
Age:
State: CO

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 10/02/2021
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: Heart palpitations/if she didn't get enough rest or sleep she would get minor heart palpitations; Extreme tiredness for days; Extreme arm swelling at the site of the injection; I got sick again; I have GI issues; I am still not feeling well; Heart palpitations could be due to dehydration, anemic; she got sick from something that she ate and it seems to have done something with her blood vessels, almost like sciatica in her leg and her side; Heart palpitations could be due to dehydration, anemic; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FL3181) via an unspecified route of administration on 17Aug2021 (at the age of 68-year-old) as a single dose for COVID-19 immunization. Patient medical history include E. Coli UTI from Jul2021 to Aug2021 and she has so many drug allergies and Mild reaction. She had taken other medications for this. Concomitant medication included ergocalciferol (VIT D [ERGOCALCIFEROL]). On 17Aug2021, patient experienced extreme arm swelling at the site of the injection like a balloon, extreme tiredness fur days for the next 2-3 weeks from 18Aug2021. On 20Aug2021 she suffered heart palpitations when she didn't sleep well the night before. Heart palpitations started on 20Aug2021, could be due to dehydration and anaemia started on an unspecified date in 2021. Last night she got sick again. she have GI issues from 2021 but it was never diagnosed. Terrible night last night. She was sick for two hours, and hour and half. She still not feeling well. She was supposed to get her 2nd dose on 07Sep2021 afternoon but that was exactly 2 weeks to her mammogram and she read that you can't get the vaccine that close to a mammogram so she didn't get it. her allergies she thought this was mild and good, but she doesn't know if she can get this again but worse with the 2nd dose. She also has been having issues and she got sick from something that she ate and it seems to have done something with her blood vessels, almost like sciatica in her leg and her side since 2021. She usually sleeps on her left side and lately she has had to sleep on her right side because she can't sleep on the left side because of the vaccine, and she doesn't know if the vaccine restricts blood vessels or not. The seriousness of events was reported as non-serious by the reporter. The outcome of the event extreme tiredness was resolved on Aug2021 while palpitation on an unspecified date in 2021 and for other events it was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1756093
Sex: F
Age:
State: FL

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 10/02/2021
Hospital: Y

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

Lab Data: Test Name: Covid tested; Result Unstructured Data: Test Result: Unknown; Comments: post vaccination.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: start having a seizure; continued to cry for headaches; the doctors say she has thyroid; bacterial meningitis; then viral meningitis; autoimmune encephalitis; vomit a few times; chills; headaches/continued to cry for headaches; This is a spontaneous report from a contactable consumer or other non hcp (parent). An 18-year-old female non-pregnant patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 02Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation at the age of 18-year-old. The patient medical history was none. No covid prior vaccination. The patient previously received dose 1 (Batch/Lot number was not reported) on 12Aug2021. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced chills and headaches on 02Sep2021, vomit a few times on 05Sep2021, start having a seizure and continued to cry for headaches on 08Sep2021, the doctors say she has thyroid, bacterial meningitis, then viral meningitis, autoimmune encephalitis on 08Sep2021. The patient was hospitalized for 13 days and hospitalization was prolonged as a result of the events. Therapeutic measures taken as a result of events included steroids, IVIG etc. Outcome of events was not recovered. Covid tested post vaccination with unknown result. The clinical course was reported as: On 02Sep202, after the patient took it she got the chills, headaches continuously until she vomit a few times on the Sunday at her dad 05Sep2021 and then she went to work on 08Sep2021 she start having a seizure the ambulance brought her to (Hospital Name Withheld) they released her then she continued to cry for headaches now she is at (Hospital Name Withheld) the doctors says she as thyroid, bacterial meningitis, then viral meningitis now autoimmune encephalitis all that reacted from the vaccine as per doctors. The events resulted in Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The lot number for, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1756094
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: hives on trunk after 1st dose recurring with second dose; This is a spontaneous report from a contactable other health professional. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers and expiry dates not reported), via unspecified routes of administration, on unspecified dates as dose 1, single and dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives on trunk after first dose recurring with second dose on unspecified date. 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: 1756095
Sex: F
Age:
State: CA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 10/02/2021
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: Test Date: 2021; Test Name: CT scans; Result Unstructured Data: Test Result: pneumonitis; Test Date: 2021; Test Name: Pet scans; Result Unstructured Data: Test Result: pneumonitis.

Allergies:

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

Symptoms: Could not breathe; Anaphylactic reaction; anaphylactic shock; Allergic reaction; wheezing like crazy; pneumonitis; This is a spontaneous report from a contactable consumer (patient) and a follow-up spontaneous report from the contactable consumer (patient) from a Pfizer Sponsored Program with Regulatory Authority support. A 62-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on 17Mar2021 15:00 (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for covid-19 immunisation at the age of 62-year-old. Medical history included Lung Cancer diagnosed in 2004 and she has had more than half of her lungs removed, Asthma diagnosed after all the cancer in 2007 or 2008, chemotherapy caused some of the blood clots, She got it by IV and she does not have lot or expiration for Chemotherapy. She received chemotherapy from 2004 to 2018. She did immunotherapy also.5 blood clots in each kidney in Feb2005 (1 on each kidney, 1 in Porta Cath, 1 in Heart and 1 in lungs at one time) and was hospitalized for that, Heartburn, systemic yeast from chemo, AFib and radiation and cyber knife, allergic to Penicillin, Sulfa, Ceftin, Benadryl, Dilaudid, and Carboplatinum. Concomitant medications included warfarin sodium (COUMADIN) taken for Blood clots from 2004 to an unspecified stop date; fluconazole (DIFLUCAN) taken for systemic yeast from chemo; omeprazole (PROTONIX [OMEPRAZOLE]) taken for Heartburn. The patient experienced anaphylactic reaction/anaphylactic shock/allergic reaction on 17Mar2021 15:45 with outcome of recovered with sequelae, could not breathe on 17Mar2021 and wheezing like crazy on 17Mar2021 with outcome of unknown, pneumonitis in 2021 with outcome of unknown. The patient was hospitalized from 19Mar2021 to 26Mar2021. The patient underwent lab tests and procedures which included computerised tomogram: pneumonitis in 2021, positron emission tomogram: pneumonitis in 2021. Therapeutic measures were taken as a result of the events. The clinical course was reported as: Patient received the 1st dose of the Pfizer COVID 19 vaccine on 17Mar2021. She had an anaphylactic reaction/shock and was hospitalized with the 1st shot. She was highly allergic with the vaccine almost killed her. The patient experienced allergic reaction which went into Anaphylactic shock on17Mar2021. It happened 45 minutes after receiving the vaccine. The patient saw Pulmonologist on 19Mar2021. She thought he would just give her a shot and a breathing treatment and he did, but said she needed to get to the hospital because it was not asthma, it was the vaccine. On 19Mar2021, she was hospitalized. She has Asthma already previously. At home she had a nebulizer. She has Lung cancer and had it prior to getting vaccine. She went and got the vaccine which is around the corner from her house and all the doctor's finally agreed she should get it because the virus is really bad, so she got it and they knew she was high risk and kept her for 30 minutes. She came home 5 minutes from there. When she got home and sat down. All of a sudden, she could not breathe. She was wheezing like crazy and thought she was having an asthma attack (She lives 50 miles from her doctor. That is why she did not go and thought she was having asthma attack). She got her nebulizer and started doing a breathing treatment. It wasn't getting better and she took a handful of steroids. She did it around the clock and did not think it was vaccine, but asthma. The medicine's were not working. She was taking Brovana inhaler in nebulizer and Budesamide in nebulizer as well. Budesamide Lot 11920 Expiration Mar2022, (Manufacturer withheld), Brovana Lot S20C019, Expiration Sep2021, (Manufacturer withheld). Steroid was Methylprednisolone. Pill 4mg. IT is in a pharmacy vial. Lot and expiration are unknown. Count size not provided. They eventually had to admit her again because the steroids were not working and they had to increase dose and give it to her IV in the hospital. She is not good moving around and got out of breath. She needed IV steroids. The ones at home were not getting it. She would send a sample. She took 10 of them in a couple of days to get breathing under control. It was only working a couple of hours. You should only do nebulizer once or twice a day and she was doing it every couple of hours. The pulmonologist admitted her within an hour. Because they were increasing her steroids at home and she was not getting better she needed higher dose and they gave her higher dose. This time they also gave IV antibiotic which was different. The patient could not breathe again on 08Sep2021 and had to be re-admitted. The event required a visit to Emergency Room on 08Sep2021 and was given IV Steroids and IV Antibiotic and Breathing treatments.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1756096
Sex: F
Age:
State: NH

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: almost passing out for many hours.; left side of my face went completely numb; I was light headed; I began throwing up and fever; I began throwing up and fever; Sense of unwell feeling not too long after receiving shot; Chills; brain fog; muscle spasms in my arm; This is a spontaneous report from a contactable other HCP (patient) A 28-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 18:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation . Age at vaccination : 28years.The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 26Jan2021 (at the age of 28 years) in arm left Batch/lot number: PAA156051 on 26Jan2021 01:00 PM. Facility where the most recent COVID-19 vaccine was administered: Othe.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccineMedical history included concussion, egg intolerance. The patient's concomitant medications were not reported. Upon second dose , on 1Feb2021, My left side of my face went completely numb. Extremely concerned considering this is typical of a stoke patient. I was light headed and almost passing out for many hours. After waiting Multiple Hours I drove 2 minutes and had to stop. My family was concerned and call the police. I had to get a ride home. I began throwing up and fever. Sense of unwell feeling not too long after receiving shot. Chills, brain fog, muscle spasms in my arm that received the shot.Seriousness criteria provided: Life threatening.No treatment received . The outcome of the events was unknown.Additonal information :The patient was not diagnosed with Covid-19 prior to vaccination; The patient has not been tested for Covid-19 since the vaccination. 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 in the narrative, a causal association between the suspect drug and the events 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:

Date Died:

ID: 1756097
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Pt received booster Covid vaccine and died the next morning in his sleep; Pt received booster Covid vaccine and died the next morning in his sleep; Pt received booster Covid vaccine and died the next morning in his sleep; This is a spontaneous report from a contactable physician via a sales representative. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received booster Covid vaccine and died the next morning in his sleep. The patient died on an unspecified date. An autopsy was being performed and results were not provided. It is believed the booster was Pfizer but that needs to be confirmed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events off label use, immunization and death and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pt received booster Covid vaccine and died the next morning in his sleep

Other Meds:

Current Illness:

ID: 1756098
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/02/2021
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: This is a spontaneous report from a non-contactable consumer. A 47-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date of Apr2021 patient experienced new onset alopecia areata. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are possible information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

Date Died: 09/23/2021

ID: 1756099
Sex: M
Age:
State: MO

Vax Date: 09/14/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
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: They said it was cardiac arrest; but the caller thinks it was a pulmonary embolism; collapsed in the bathroom at 10pm; He was having trouble breathing. He collapsed in the bathroom at 10pm; he wasn't feeling well; This is a spontaneous report from a contactable consumer (patient's son). A 57-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 14Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at the age of 57-year-old. Medical history included alcoholism, seizures. There were no concomitant medications. The patient experienced cardiac arrest on 23Sep2021, pulmonary embolism on 23Sep2021, trouble breathing and collapsed in the bathroom at 10pm in Sep2021, wasn't feeling well in Sep2021. The patient died on 23Sep2021. An autopsy was not performed. The outcome of wasn't feeling well was unknown, outcome of other events was fatal. The clinical course was reported as: his father died yesterday, and the only difference recently in his health was that he got the COVID vaccine. His father died 9 days later on 23Sep2021. The coroner denied an autopsy. The hospital denied an autopsy. His father was not obese or diabetic, and he was only 57 as healthy as a horse. His father had gotten the vaccine, and said he wasn't feeling well to his girlfriend. He was having trouble breathing. He collapsed in the bathroom at 10pm. They called an ambulance who did everything they could do to bring him back. They pronounced his dad dead 23 minutes after midnight on 23Sep2021. They said it was cardiac arrest, but the reporter thinks it was a pulmonary embolism. His dad was not COVID positive. His father did have a history of alcoholism. Any time he would try to quit drinking, he would drink too much water out of compulsion since he couldn't drink beer. He would flush his system so much that he would deplete his sodium. His dad would get seizures every time he quit drinking. He tried to tell his dad that he needed to drink the normal amount of water. He can't just sit there and drink that much water to replace all the beer he drank. It would flush his system of all that sodium. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Reported Cause(s) of Death: They said it was cardiac arrest; but the caller thinks it was a pulmonary embolism; He was having trouble breathing. He collapsed in the bathroom at 10pm

Other Meds:

Current Illness:

ID: 1756100
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: D- dimer; Test Result: Positive

Allergies:

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

Symptoms: developed bleeding spot on hand and fingers same side as injection/ Left side hand and fingers had several spots, 3 or 4 of the fingers and on the palm. Several spots. All together like 8 spots; positive D- dimer; This is a spontaneous report from a contactable physician. A 75-years-old male patient received bnt162b2 (BNT162B2, PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, in arm left on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strange reaction after getting the second dose of the Pfizer covid vaccine. The patient asked if he can get the third dose or not. He described the reaction as within 24 hours after the second dose, he developed what looked like a bleeding spot on his hand, on the palm of the hand and fingers, on the same side he received the injection/ left side hand and fingers had several spots, 3 or 4 of the fingers and on the palm. several spots. all together like 8 spots. It was not painful or raised. He had bloodwork done that showed a positive d dimer and he had no other symptoms. The bleeding spot disappeared within 24 hours. The patient received first dose of bnt162b2 (BNT162B2, PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. The patient's lab data included positive D- dimer. The outcome of the event bleeding spot on his hand, on the palm of the hand and fingers was recovered on an unknown date and of the event showed a positive d dimer was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Haemorrhage subcutaneous and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1756101
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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 Name: Blood test; Result Unstructured Data: Test Result:Ok; Comments: Caller stated her blood tests came back OK

Allergies:

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

Symptoms: her neuropathy had only been numbness and tingling until that point and when she had the vaccine it flared up; her neuropathy had only been numbness and tingling until that point and when she had the vaccine it flared up; stated the pain in the wrist and hand is a 12 in pain; could hardly walk; joint pain/pain in her left hip and neck/joint pain in her left arm and wrist/neck, hip, shoulder and elbow pain; pain in her left hip and neck; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 74-years-old female patient received first dose of BNT162B2 (COMIRNATY, 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. The patient's medical history included MOS surgery (Micrographic skin surgery). The patient's concomitant medications were not reported. The patient stated that she took Humira and two months after she had an outbreak of skin cancer. The patient stated that she had her 44th removal and had 8 to 10 MOS surgeries noting it started over 2 years ago and is still ongoing. The patient had the first dose of the Pfizer COVID 19 vaccine about two months ago. The patient stated that her neuropathy had only been numbness and tingling until that point and when she had the vaccine it flared up noting it got so bad she could hardly walk on an unspecified date. The patient reported that starting 2 to 3 weeks ago, she began to have joint pain. The patient reported joint pain in her left arm and wrist. The patient stated it has gotten worse in the past 3 to 4 days. The patient stated she could not use her left wrist in 3 days. The patient also reported pain in her left hip and neck. The patient reported the neck, hip, shoulder and elbow pain was better that day. The patient stated that the pain in the wrist and hand was a 12 in pain. The patient stated that the severity was about 5 days and going on for 2-3 weeks. The patient stated that she was having a rough time. The patient reported that the pain was flipping from the right arm and neck and the next day it was somewhere else, noting it flips from one side to the other. The patient stated that she could not use her right arm at all. The patient stated her blood tests came back ok on an unspecified date. The patient asked if other people reported the same joint pain and how long did it last. The patient wanted to know if it was going to go away. The patient wanted to know what she could do about the pain and asked if she just has to deal with it. The patient was referred to HCP. It was reported that it had been over 42 days since the first dose and patient had not received the second dose. The outcome of the events 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: Neuropathy (When she had the vaccine it flared up noting it got so bad she could hardly walk.)

ID: 1756102
Sex: F
Age:
State:

Vax Date: 09/25/2021
Onset Date: 09/25/2021
Rec V Date: 10/02/2021
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: kind of difficulty swallowing or numb; numb is associated with difficulty in swallowing; having some tingling in her mouth; soring in the throat; pain moving up radiating up to the ear; tingling thumb; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in Arm Left on 25Sep2021 (Batch/Lot Number: FC3183; Expiration Date: Oct2021) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced having some tingling in her mouth kind of difficulty swallowing or numb, numb was associated with difficulty in swallowing of but an increased hard time swallowing so they gave the patient some Benadryl 25 mg as treatment. The patient had difficulty in swallowing, some soring in the throat, tingling thumb and pain moving up radiating up to the ear. The events occurred on 25Sep2021. Her second dose was scheduled on 16Oct2021. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1756103
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Her neck has bothered her and is got Inflamed after getting the dose and also her auto immune information got worse.; Her neck has bothered her and is got Inflamed after getting the dose and also her auto immune information got worse.; Her neck has bothered her and is got Inflamed after getting the dose and also her auto immune information got worse.; pain; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 02Aug2021 (at the age of 76-years-old) at dose 1, single in the right arm for COVID-19 immunisation. Medical history included thyroid disorder. Concomitant medication included steroids for thyroid disorder, and aniprazol. On an unspecified date in 2021, after the patient got the first dose of Pfizer COVID-19 vaccine, the patient stated that her neck bothered her and got inflamed. Also, her auto immune information got worse. The patient had pain. The patient did not receive the second dose due to this. Due to the events, the patient was treated with two injections in her neck and spine. The patient was waiting to get an abrasion in her neck on 04Oct2021, because of the pain (started on an unspecified date on 2021). The patient's inflammation increased a lot after the vaccination. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1756104
Sex: F
Age:
State:

Vax Date: 08/27/2021
Onset Date: 09/20/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210920; Test Name: Tested positive for COVID; Test Result: Positive

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable pharmacist (patient's mother) via the regulatory authority. This pharmacist reported similar events for 5 patients. This is the 3rd of 5 reports. A 19-year-old female patient received BNT162B29 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on 27Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Sep2021, she tested positive for COVID, and didn't receive the second dose. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202101275398 same reporter, same drug, same event, different patient

Other Meds:

Current Illness:

ID: 1756105
Sex: F
Age:
State:

Vax Date: 05/17/2021
Onset Date: 09/20/2021
Rec V Date: 10/02/2021
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: 20210920; Test Name: Tested positive for COVID; Test Result: Positive

Allergies:

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

Symptoms: tested positive for Covid; tested positive for Covid; She says this was the sickest she has been in twenty years; This is a spontaneous report from a contactable pharmacist (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17May2021 as DOSE 2, SINGLE, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical his-tory and concomitant medications were not reported. On 20Sep2021, the patient reported she, her husband, and her other two daughters also tested positive for Covid. She stated this was the sickest she has been in twenty years. The patient underwent lab tests and procedures which included COVID test positive on 20Sep2021. The outcome was unknown for the events. 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 self) via the Medical Information Team. This pharmacist reported similar events for 5 patients. This is the 4th of 5 reports.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1756106
Sex: M
Age:
State: OH

Vax Date: 03/02/2021
Onset Date: 08/01/2021
Rec V Date: 10/02/2021
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 Date: 20210810; Test Name: COVID-19 Test; Test Result: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: received their Pfizer COvid-19 Vaccine series, tested positive for COVID-19.; felt bad; lost their smell and taste; can't smell right; lost their smell and taste; received their Pfizer COvid-19 Vaccine series, tested positive for COVID-19.; This is a spontaneous report from a sponsored Program. A contactable consumer (wife) or other non-health professional reported for a Patient (Husband) that: A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown) on 02Mar2021 as dose 2, single and on 11Feb2021 as dose 1, single both via unspecified route of administration, administered on left arm (at the age of 69-year-old) for covid-19 immunisation. Medical history included Blood Pressure, gout. Concomitant medications included blood pressure medication (reported as that's a small dose), Multivitamin and medication to reduce his uric acid indicated for gout all are via an unspecified route of administration ongoing from an unknown date. On an unspecified that in 2021 Patient experienced received their Pfizer COvid-19 Vaccine series, tested positive for COVID-19, on Aug2021 lost their smell and taste, can't smell right and on 09Aug2021 experienced felt bad. It was reported that patient tested positive for COVID on 10Aug2021. Patient still can't smell right. Reporter is asking how long after testing Positive for COVID-19 do they have to wait before receiving their Booster dose. They had their 2nd doses back in Mar2021 and then both her and her husband had breakthrough COVID cases. Patient tested positive on 10Aug2021. 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. He had felt bad on 09Aug2021. Probed for the dates, NDCs, lot numbers and expiry dates for her husband's COVID vaccine and she says that she does not have his COVID vaccine record card to provide that but he got them at the same time as her. It was at a drive true at the football stadium. He had his on the same dates as her, confirmed again to 11Feb2021 and 02Mar2021. They went through the drive thru type thing for it and they gave his vaccines in his left arm and gave her hers in her right arm. Patients takes a blood pressure medication that's a small dose and a multivitamin and he also takes a medication to reduce his uric acid because he has a history of gout but she doesn't know names, start dates or dosages. Reporter forgot to mention this but both her and her husband had lost their smell and taste. 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. Patient was not admitted to the hospital. Patient underwent lab test and procedures include COVID-19 Test-positive on 10Aug2021. Outcome of the event Lost smell recovering and outcome of other events was unknown. Reporter seriousness for had breakthrough COVID case: Unspecified. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1756107
Sex: M
Age:
State: PA

Vax Date: 04/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 202009; Test Name: Covid test; Test Result: Negative ; Test Date: 202101; Test Name: Covid test; Test Result: Negative ; Test Date: 202102; Test Name: Covid test; Test Result: Negative ; Test Date: 202104; Test Name: Covid test; Test Result: Negative ; Test Date: 202105; Test Name: Covid test; Test Result: Negative ; Test Date: 202109; Test Name: Covid test; Test Result: Positive

Allergies:

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

Symptoms: Contracted COVID/COVID-19 positive; Contracted COVID/COVID-19 positive; sinuses felt weird; This is a spontaneous report from a contactable consumer. A 23-year-old (also the age at time of vaccination) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and then in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE both given intramuscularly for COVID-19 immunization at the Pharmacy or Drug Store. Medical history included cat and dog allergy. Concomitant medications were not reported. The patient had no COVID prior vaccination. In Sep2021, the patient mentioned that he contracted COVID as his sinuses "felt weird", dry throat, and mild headache. The patient had positive COVID-19 test in Sep2021. He had negative COVID-19 test in Sep2020, Jan2021, Feb2021, Apr2021 and May 2021. The patient did not received any treatment for the events and recovered in 2021. Information regarding the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1756108
Sex: F
Age:
State:

Vax Date: 10/01/2020
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: reports taking 5mg once daily 23Aug2021 through 13Sep2021 for covid vaccine. during this time patient reports an outbreak of shingles; This is a spontaneous report from a contactable other hcp from a Specialty Pharmacy. A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Aug2021 (at the age of 78-year-old) as dose 1, single; dose 2 via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported) as dose 2, single, both doses for COVID-19 immunization; tofacitinib citrate (XELJANZ, Batch/Lot number was not reported) 5 mg at a dose of 5 mg twice daily via oral route from on an unspecified date in Oct2020 and ongoing, another dose at 5 mg once daily, via oral route on an unspecified date in 2021 for rheumatoid arthritis. The patient medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced reports taking 5mg once daily 23aug2021 through 13sep2021 for covid vaccine. During this time patient reports an outbreak of shingles. Describe Event, Problem or Product Use Error: patient reports taking 5mg once daily 23Aug2021 through 13Sep2021 for covid vaccine, md aware. During this time patient reports an outbreak of shingles. patient reports that she is now back on xeljanz taking her normal dose of 5mg twice daily, but she cannot remember the date she restarted her normal dose. md aware. no further information or details reported. The action taken in response to the event for tofacitinib citrate was unknown. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am