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: 1789805
Sex: U
Age:
State: MO

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/16/2021
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: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter

Other Meds:

Current Illness:

ID: 1789806
Sex: U
Age:
State: MO

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/16/2021
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: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter

Other Meds:

Current Illness:

ID: 1789807
Sex: U
Age:
State: MO

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/16/2021
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: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter

Other Meds:

Current Illness:

ID: 1789808
Sex: U
Age:
State: MO

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/16/2021
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: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter

Other Meds:

Current Illness:

ID: 1789809
Sex: U
Age:
State: MO

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/16/2021
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: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter

Other Meds:

Current Illness:

ID: 1789810
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he or she got the Shingle shot and also got shingles later. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1789818
Sex: U
Age:
State: ME

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: patients were vaccinated with Fluarix after being out of range; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LZ4N2, expiry date unknown) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that 300 patients were vaccinated with Fluarix after being out of range for 2 weeks. The reporter did not consent to follow-up. The health care professional provided limited information since didn't have expiration date of the vaccine, or any other demographic details from vaccinated.

Other Meds:

Current Illness:

ID: 1789823
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Expired(June 30,2021) dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a child patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number unknown, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient was administered with Flulaval quadrivalent vaccine which was expired 30th June 2021. The patient had no effects at the time of reporting. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1789829
Sex: U
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: went below freezing point; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not applicable to this report. The nurse reported that, the several vaccines Bexsro, Menveo, Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Rotarix that went below freezing point was inadvertently administered to patient over a period of time, which led to incorrect storage of drug. The reporter consented to follow up. No details of patient or other vaccine details were available.

Other Meds:

Current Illness:

ID: 1789846
Sex: M
Age: 17
State:

Vax Date: 10/12/2021
Onset Date: 10/12/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 52S9R, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 12th October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received an expired dose of Fluarix QIV, which led to expired vaccine used. The reporter consented to follow up. The case has been linked with the case US2020093493 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020093493:same reporter

Other Meds:

Current Illness:

ID: 1789848
Sex: U
Age:
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: maladministration after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used. The reporter consented to follow up by email. No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021211495:same reporter US-GLAXOSMITHKLINE-US2021211493:same reporter US-GLAXOSMITHKLINE-US2021211492:same reporter

Other Meds:

Current Illness:

ID: 1789849
Sex: U
Age:
State: MO

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: received Fluarix after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used. The reporter consented to follow up by email. No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021211489:same reporter US-GLAXOSMITHKLINE-US2021211493:same reporter US-GLAXOSMITHKLINE-US2021211495:same reporter

Other Meds:

Current Illness:

ID: 1789850
Sex: U
Age:
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: received Fluarix after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used. The reporter consented to follow up by email. No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021211492:same reporter US-GLAXOSMITHKLINE-US2021211489:same reporter US-GLAXOSMITHKLINE-US2021211495:same reporter

Other Meds:

Current Illness:

ID: 1789851
Sex: U
Age:
State: MO

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: received Fluarix after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used. The reporter consented to follow up by email. No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021211492:same reporter US-GLAXOSMITHKLINE-US2021211493:same reporter US-GLAXOSMITHKLINE-US2021211489:same reporter

Other Meds:

Current Illness:

ID: 1789857
Sex: F
Age: 11
State: CO

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Infanrix to a 11 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 52m39, expiry date 25th November 2022) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 29th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient was administered Infanrix at 11 year of age, which led to inappropriate age at vaccine administration. No further events were reported. The reporter agreed to be contacted for follow-up.

Other Meds:

Current Illness:

ID: 1789858
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: were stored below temperature and not viable but administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patient who received HAV (Havrix) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Havrix, Havrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not applicable to this report. The medical assistant reported that Havrix, Engerix, and Infanrix were stored below temperature and administered to unknown number of patients, which led to incorrect storage of drug. The vaccines were deemed not viable. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1789859
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
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: 2021; Test Name: COVID-19 virus test; Result Unstructured Data: positive

Allergies:

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

Symptoms: FLUID WAS LOW; MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; NAUSEA; HEADACHE; SUSPECTED CLINICAL VACCINE FAILURE; COVID-19; This solicited pregnancy report received from a consumer concerned a 32 year female. The patient was enrolled in a non-company sponsored study. The patient's weight was 61.224 kilograms, and height was 160 centimeters. The patient's past medical history included: recreational drug use and concurrent conditions included: asthma, non-smoker and no alcohol use. The patient was gravida 1, para 0. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, frequency time 1 total, administered to the left arm on 01-APR-2021 for covid-19 immunisation. Concomitant medications included docosahexaenoic acid and topiramate. The date of the patient's last menstrual period was 16-NOV-2020 and expected delivery date was 23-AUG-2021. Type of pregnancy was reported as singleton. On the same day (01-APR-2021), the patient experienced ache in the left arm where she was injected (sore arm) and also experienced maternal exposure during pregnancy. Several hours later, around bedtime, the patient experienced headache and felt nauseous. She took some Tylenol and woke up the next morning feeling fine, except for the ache in her left arm. The left arm continued to ache for several days, but eventually resolved on 05-APR-2021. On 26-AUG-2021, it was identified that patient's amniotic fluid was low, which led to induction of labor. The patient vaginally delivered a live, full-term, female neonate. The patient spent one day in the hospital for the delivery. The neonate's birth weight was 6 pounds and 10 ounces and body length was 20 inches. On an unknown date in 2021, the patient was diagnosed with COVID-19 (coded as COVID-19 and suspected clinical vaccine failure). No medication was used to treat COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 05-APR-2021, and nausea, and headache on 01-APR-2021, and the outcome of maternal exposure during pregnancy, fluid was low, covid-19 and suspected clinical vaccine failure was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and fluid was low as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, suspected clinical vaccine failure, covid-19, sore arm, nausea, and headache. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, suspected clinical vaccine failure, and covid-19 was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, nausea, and headache was related. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197037. This case was reassessed as serious based on additional information received from a consumer on 06-OCT-2021. The following information was updated and incorporated into the case narrative: added patient race, medical history, expected delivery date (23-AUG-2021), end of pregnancy date (27-AUG-2021) and delivery details. Added events fluid was low, suspected clinical vaccine failure and covid-19. Updated outcome of event maternal exposure during pregnancy to Unknown. Added docosahexaenoic acid as concomitant medication and Tylenol as drug used to treat AE. Start date for topiramate. Vaccination site. Narrative updated accordingly.; Sender's Comments: V1: 20210805745-covid-19 vaccine ad26.cov2.s-fluid was low. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210805745-covid-19 vaccine ad26.cov2.s-maternal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210805745-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: TOPIRAMATE; PRENATAL DHA

Current Illness: Abstains from alcohol; Asthma; Non-smoker

ID: 1789860
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 20210429; Test Name: Ultrasound scan; Result Unstructured Data: Marginal cord insertion

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: DELIVERY AT GESTATIONAL AGE 36 WEEKS AND TWO DAYS; MARGINAL CORD INSERTION; MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; HEADACHE; This solicited pregnancy report received from a consumer concerned a 39 year old female of unspecified ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 85.26 kilograms, and height was not reported. The patient Body Mass Index (BMI) was 22.21. The patient's concurrent conditions included: anxiety, and attention deficit disorder. Patient had history of multigravida. Patient had no history of exposure to drugs for recreational use, tobacco use, or alcoholic beverage consumption. The patient's obstetrical history included two previous pregnancies, of which one resulted in live newborn. The first day of the last menstrual period (LMP) was calculated to be 05-DEC-2020. The estimated delivery date (EDD) was reported to be 11-SEP-2021. It was reported that this was singleton pregnancy. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 at gestational age 17 weeks 3 days for covid-19 immunisation. Concomitant medications included doxylamine succinate, fluoxetine hydrochloride, and minerals nos/vitamins nos. On 06-APR-2021, within 48 hours after receiving the (Ad26.COV2-S) vaccine, patient experienced headache, sore arm and maternal exposure during pregnancy. On 29-Apr-2021, patient experienced marginal cord insertion. It was stated that provider requested ultrasounds every 4 weeks to monitor baby's growth. No issues were noted. On 16-Aug-2021, at gestational age 36 weeks and two days, patient vaginally delivered a live, pre-term, male neonate. Patient spent two days in the hospital for the delivery. On 18-AUG-2021 patient was discharged from hospital. The neonate's birth weight was 6.43 (6 pounds and 7 ounces), body length was 18 inches. The neonate spent more than 10 days in Neonate Intensive Care Unit (NICU) due to problems with breathing. Laboratory data included: Ultrasound scan (NR: not provided) Marginal cord insertion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache, had not recovered from marginal cord insertion, and the outcome of maternal exposure during pregnancy and delivery at gestational age 36 weeks and two days was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and marginal cord insertion as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and delivery at gestational age 36 weeks and two days, maternal exposure during pregnancy, sore arm, and headache. Company causality between covid-19 vaccine ad26.cov2.s, and sore arm, and headache was related, and between covid-19 vaccine ad26.cov2.s, and marginal cord insertion, delivery at gestational age 36 weeks and two days, maternal exposure during pregnancy was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20211011488. This case was reassessed as serious based on additional information received from a consumer on 06-OCT-2021. The following information was updated and incorporated into the case narrative: event added (delivery at gestational age 36 weeks and two days, event marginal cord insertion), event maternal exposure during pregnancy upgraded to serious and outcome of event headache, sore arm updated to recovered, patient medical history, pregnancy related information added, causality, labelling updated accordingly.; Sender's Comments: V1: 20210728727-covid-19 vaccine ad26.cov2.s- marginal cord insertion, delivery at gestational age 36 weeks and two days. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210728727-covid-19 vaccine ad26.cov2.s-maternal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: PROZAC; UNISOM SLEEP; PRENATAL PLUS

Current Illness: Abstains from alcohol; Anxiety; Attention deficit disorder; Non-smoker

ID: 1789861
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/05/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: no problem or concern; Comments: cell-free DNA screening, alfa fetoprotein, or the quad screen and a nuchal translucency screen test; Test Date: 20210720; Test Name: Diagnostic ultrasound; Result Unstructured Data: prenatal ultrasound

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: MARGINAL CORD INSERTION; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 32 year old female. The patient's weight was 63.49 kilograms, and height was not reported. The patient's past medical history included: miscarriage, and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient had no history of tobacco, alcohol, or recreational drug use. Type of pregnancy was reported as singleton. The gestational age was four weeks and six days. The date of the patient's last menstrual period was 02-MAR-2021 and expected delivery date was 07-DEC-2021. The pregnancy was continuing. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose was not reported, administered on 05-APR-2021 for prevention of COVID-19. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included minerals nos/vitamins nos. On unknown date during 2021, the patient had blood tests, such as cell-free DNA screening, alfa fetoprotein, or the quad screen and a nuchal translucency screen test. None of the tests showed any problem or concern. On 05-APR-2021, the patient experienced maternal exposure during pregnancy. On 20-JUL-2021, the patient experienced marginal cord insertion. Laboratory data included: Diagnostic ultrasound (NR: not provided) which showed marginal cord insertion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the maternal exposure during pregnancy and marginal cord insertion was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and marginal cord insertion as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy and marginal cord insertion was not related. This report was serious (Other Medically Important Condition). Additional information was received from patient on 06-Oct-2021. The following information was updated and incorporated into the case narrative: Event (marginal cord insertion added), lab (prenatal ultrasound added) and narrative.; Sender's Comments: V1: 20210763185-covid-19 vaccine ad26.cov2.s-Marginal cord insertion. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY . 20210763185-covid-19 vaccine ad26.cov2.s- Maternal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1789862
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Name: Prenatal cell-free DNA screening; Result Unstructured Data: Normal; Test Name: Foetal nuchal translucency ultrasound; Result Unstructured Data: Normal; Test Name: Alphafetoprotein; Result Unstructured Data: Normal

Allergies:

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

Symptoms: Premature delivery WEEKS; PRE-ECLAMPSIA; ECLAMPSIA; FATIGUE; MUSCLE PAIN; SWELLING AT INJECTION SITE; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 36 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 115.65 kilograms, and height was not reported. The patient's concurrent conditions included: anxiety, depression, type II diabetes mellitus, blood pressure high, polycystic ovarian syndrome, and overweight. The patient was gravida 1, para 1. The patient had no obstetrical history and did not use drugs for recreational use, tobacco, or alcohol. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number unknown, expiry unknown) dose was not reported, 01 total, administered on 24-MAR-2021 for COVID-19 immunisation. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included caffeine/magnesium salicylate (Diurex Water Pills), docosahexaenoic acid (Prenatal DHA), insulin aspart (Novolog), insulin detemir (Levemir), saccharated iron oxide (Venofer), Labetalol, losartan potassium, and nifedipine (Procardia) for unknown indication, On 24-MAR-2021, the patient had maternal exposure during pregnancy, muscle pain, swelling at injection site. On 26-MAR-2021, the patient experienced fatigue. On 01-JUL-2021, the patient had pre-eclampsia. On an unspecified date in JUL-2021, the patient had eclampsia. The date of the patient's last menstrual period was 30-OCT-2020 and delivery resulted in a live birth (premature delivery.The patient gave birth via caesarean section (C- section). The female baby weighed 5.5 pound and was 20-inch height. Gestation period was 35 weeks and two days at the time of delivery (20 weeks at the time of event onset). The patient spent four days in the hospital for the delivery. On an unspecified date, the patient was hospitalized, number of days hospitalized, and discharge information was not reported. On an unspecified date, laboratory data included: Alphafetoprotein, Foetal nuchal translucency ultrasound, Prenatal cell-free DNA screening, quada and results were normal (no problem detected). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 29-MAR-2021, and muscle pain, and swelling at injection site on 31-MAR-2021, had not recovered from eclampsia, and pre-eclampsia, and the outcome of maternal exposure during pregnancy and premature delivery was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and eclampsia, and pre-eclampsia as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and premature delivery, maternal exposure during pregnancy, fatigue, muscle pain, and swelling at injection site. Company causality between covid-19 vaccine ad26.cov2.s, and premature delivery, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and fatigue, muscle pain, and swelling at injection site was related. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage). This parent/child case is linked to 20211009718. Additional information was received from consumer on 05-OCT-2021. The following information was updated and incorporated into the case narrative: New events (Eclampsia, premature delivery weeks and pre-eclampsia), maternal exposure during pregnancy serious updated to serious, Pregnancy outcome (live birth), Pregnancy type (Retrospective), date of pregnancy, causality and all concomitant medications.; Sender's Comments: V1: This version updates information about: New events (Eclampsia, premature delivery and pre-eclampsia), maternal exposure during pregnancy updated to serious, Pregnancy outcome (live birth), Pregnancy type (Retrospective), date of pregnancy, causality and all concomitant medications. 20210800681-COVID-19 VACCINE AD26.COV2.S- Eclampsia, pre-eclampsia, delivery at premature delivery weeks. Follow-up received regarding Clinical Details. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE 20210800681-COVID-19 VACCINE AD26.COV2.S- Maternal exposure during pregnancy. Follow-up received regarding Clinical Details. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: LOSARTAN POTASSIUM; LEVEMIR; NOVOLOG; PRENATAL DHA; VENOFER; PROCARDIA [NIFEDIPINE]; DIUREX WATER PILLS; LABETALOL

Current Illness: Abstains from alcohol; Anxiety; Depression; Hypertension; Overweight; Polycystic ovaries; Type 2 diabetes mellitus

ID: 1789864
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 10/16/2021
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: Test Date: 20210909; Test Name: Ultrasound foetal; Result Unstructured Data: unknown

Allergies:

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

Symptoms: MISCARRIAGE; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; SORE ARM; FEVER; MATERNAL EXPOSURE DURING PREGNANCY; WEIRD FEVER DREAMS; This solicited pregnancy report received from a consumer concerned a 36 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 58.05 kilograms, and height was not reported. The patient's Body Mass Index (BMI) was 23.22. The patient's concurrent conditions included: no tobacco use, and no alcohol use and The patient had no history of exposure to drugs for recreational use. The patient was gravida 2, para 1. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021, and dose was not reported, 1 total administered on 29-JUL-2021 (Inappropriate dose of Vaccine administered) for prevention of covid-19. Concomitant medications included minerals nos/vitamins nos and sertraline hydrochloride for drug used for unknown indication. On 06-APR-2021 within 48 hours, the patient experienced weird fever dreams, sore arm and fever. The date of the patient's last menstrual period was 07-JUL-2021 and expected delivery date is 13-APR-2022 and It was singleton pregnancy. On 29-Jul-2021, the patient had maternal exposure during pregnancy, at gestational age 3 weeks and 1 day, the patient received the second dose of the JANSSEN or JOHNSON &JOHNSON (Ad26.COV2-S) vaccine for the prevention of COVID-19. The patient was the part of a clinical trial. On 09-Sep-2021, the confirmation ultrasound showed no detectable heartbeat and fetus was measured 6 weeks instead of expected 9 weeks. On 16-Sep-2021, at gestational age 10 weeks and 1 days, the miscarriage was confirmed and patient underwent dilation and curettage procedure on 17-Sep-2021. On an unspecified date, the pregnancy resulted in a spontaneous abortion. No additional details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird fever dreams, sore arm, and fever on 07-APR-2021, and the outcome of maternal exposure during pregnancy, miscarriage and inappropriate dose of vaccine administered was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and miscarriage, weird fever dreams, sore arm, and fever was related, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, and inappropriate dose of vaccine administered was not related. This report was serious (Other Medically Important Condition). Additional information was received from patient on 29-SEP-2021. The following information was updated and incorporated in to the case narrative: patient history including pre-existing condition added, event added (miscarriage, Inappropriate dose of Vaccine administered), in product tab batch/lot number, drug used to treat ae added (prenatal vitamins), lab added(ultrasound fetal).; Sender's Comments: V0: 20210941092-covid-19 vaccine ad26.cov2.s-maternal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210941092-covid-19 vaccine ad26.cov2.s-Miscarriage. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: ZOLOFT; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness: Abstains from alcohol; Non-smoker

ID: 1789865
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: 202109; Test Name: Blood test; Result Unstructured Data: No evidence of covid-19 vaccine

Allergies:

Symptom List: Unevaluable event

Symptoms: LACK OF EFFECT/ NO EVIDENT OF THE PATIENT HAVING HAD THE JANSSEN COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 55 year old male. Initial information was processed along with additional information received from a department on 04-OCT-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and Expiry: Unknown) dose was not reported,1 total, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in SEP-2021, the patient went to the doctor for routine blood work and was told that there was no evidence of the Janssen Covid-19 vaccine in his system (Lack of effect/ no evident of the patient having had the Janssen Covid-19 vaccine administered). The doctor specify that he should receive another vaccine, possibly Pfizer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lack of effect/ no evident of the patient having had the Janssen covid-19 vaccine administered was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000195676.; Sender's Comments: V0:20211004100-covid-19 vaccine ad26.cov2.s-lack of effect/ no evident of the patient having had the Janssen covid-19 vaccine administered. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1789866
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: DEAFNESS FOR ABOUT 2 DAYS; PSYCHOTIC EPISODES; COULD NOT WALK; KICKING LEGS AND HANDS; MUMBLING; CARRYING ON; SHAKING; GOT REAL HOT, DIDN'T WANT FAN ON; THOUGHT HUSBAND WAS STILL ALIVE; COULD NOT GET UP; GONE BACK IN TIME ONE MINUTE AND IN RIGHT MIND THE NEXT; NO STRENGTH; This spontaneous report received from a consumer concerned an unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in SEP-2021, about 2 weeks after vaccination, patient experienced ringing in ears and deafness for about 2 days. According to the reporter, it was an epileptic seizure but this was not diagnosed. The patient did not know what she was doing: kicking legs and hands, mumbling, carrying on, shaking, she got real hot and did not want the fan on. Then she had psychotic episodes that lasted about 2 days after the ringing in ears and hearing/ deafness stopped. She did not have a fever. After that patient did not have any more episodes. She thought her husband was still alive. On an unspecified date, patient was hospitalised for about 5-6 days and then she was sent to a behavioral center for 8-9 days. As per the reporter, patient was still in the hospital. Patient had been having effects like back in time one minute and in right mind the next. Patient stayed in bed 4 days after she got the shot. She could not get up and walk and did not have the strength. Reporter advised the patient to contact her HCP for advise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deafness for about 2 days, psychotic episodes, kicking legs and hands, mumbling, carrying on, shaking, and got real hot, didn't want fan on, and the outcome of could not get up, could not walk, thought husband was still alive, gone back in time one minute and in right mind the next and no strength was not reported This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211006204-covid-19 vaccine ad26.cov2.s -Deafness for about 2 days, psychotic episodes, could not walk, kicking legs and hands, mumbling, carrying on, shaking, got real hot, didn't want fan on, thought husband was still alive, could not get up, gone back in time one minute and in right mind the next. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211006204-covid-19 vaccine ad26.cov2.s -No strength. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1789868
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: PAIN; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included upadacitinib for moderate to severe rheumatoid arthritis. On an unspecified date, the patient experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain. This report was non-serious.

Other Meds: RINVOQ

Current Illness: Rheumatoid arthritis

ID: 1789869
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 03/05/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 20210305; Test Name: Blood pressure; Result Unstructured Data: 170/116; Test Date: 20210305; Test Name: Heart rate; Result Unstructured Data: 160s-170s; Test Date: 20210310; Test Name: Blood pressure; Result Unstructured Data: 170/120; Test Date: 20210310; Test Name: Heart rate; Result Unstructured Data: 145-150s; Test Date: 20210317; Test Name: Fibrin D dimer; Result Unstructured Data: Elevated; Test Date: 20210317; Test Name: CAT scan; Result Unstructured Data: Did not have any diagnosis; Comments: No blood clots were found; Test Date: 20210317; Test Name: Heart rate; Result Unstructured Data: Elevated; Test Date: 20210317; Test Name: Blood test; Result Unstructured Data: Did not have any diagnosis; Comments: No blood clots were found; Test Date: 20210317; Test Name: Blood pressure; Result Unstructured Data: Elevated; Test Date: 202104; Test Name: Cardiac stress test; Result Unstructured Data: Preventricular contractions; Comments: Tests showed Preventricular contractions but the Cardiologist stated that it was normal.; Test Date: 202104; Test Name: MRI; Result Unstructured Data: Normal; Test Date: 202104; Test Name: Ultrasound kidney; Result Unstructured Data: Not reported; Test Date: 202104; Test Name: Echocardiography; Result Unstructured Data: Normal; Test Date: 202104; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: 92; Test Date: 202104; Test Name: Ultrasound kidney; Result Unstructured Data: Not reported; Test Date: 202104; Test Name: Laboratory test; Result Unstructured Data: Not reported; Test Date: 20210416; Test Name: Blood pressure; Result Unstructured Data: 200/110; Test Date: 20210519; Test Name: Tilt table test; Result Unstructured Data: Normal

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: HIGH BLOOD PRESSURE SPIKES 3-4 TIMES A WEEK; ULCERATIVE COLITIS FLARE UP; DIZZINESS AND LIGHTHEADEDNESS; INSOMNIA; LOSS OF APPETITE; SHORTNESS OF BREATH; LEGS FEEL WEIRD SOMETIMES (TINGLING AT NIGHT); HEART RATE STARTED RACING; This spontaneous report received from a patient (Doctor in nurse practitioner) concerned a 41-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: ulcerative colitis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1802068 expiry: unknown) dose was not reported, frequency time 1 total administered in left deltoid on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021 within 20 minutes after vaccination patient experienced having a blood pressure of 170/116, heart rate of 160s-170s. The patient continued to have High blood pressure spikes 3-4 times a week (crisis level). Patient continued to have heart rate increase episodes multiple times a day. Also lost 20-25 pounds since March-2021 and her pre-existing ulcerative colitis flared up the day after getting the vaccine, diarrhea due to colitis flare up the next day after vaccination and loss of appetite the day after getting the vaccine. Other symptoms included shortness of breath, dizziness, lightheadedness, legs feel weird sometimes (tingling at night) and insomnia. On the same day patient visited first hospital right after getting the vaccine. The patient stated that she had multiple repeats of such events with high blood pressure and heart starting to race. The first emergency room visit was within a week (07-MAR-2021). Recommendations made: Ruled out blood clot. The second ER visit was on the 10-MAR-2021 heart rate 145-150s, and blood pressure 170/120. The patient was started on Metoprolol and sent home. 1 week later on 17-MAR-2021 she went to the emergency room again with an elevated blood pressure and Heart rate. They checked her blood pressure and blood work and did several (about 4) computerized axial tomography scans of the chest to look for blood clots, but they did not have any diagnosis. No blood clots were found but D-dimer was elevated. On 16-APR-2021 patient went to the emergency room for blood pressure of 200/110 and then was admitted for two days until 18-APR-2021. During this stay checked her kidneys for secondary hypertension, did an ultrasound of the kidney and then the Cardiologist in the Hospital ruled out other renal sources of the symptoms and scheduled an outpatient magnetic resonance imaging of the kidneys. The magnetic resonance imaging was normal. Patient also did a cardiac stress test, tilt table test and ultrasound of kidneys, and lab work for hormones. The tilt table results were done on 19-MAY-2021 and were normal. Stress tests showed Preventricular contractions, but the Cardiologist stated that it was normal and patient had rate changes but not rhythm changes. Erythrocyte sedimentation rate was 92. Bubble study was done and it was normal. The patient had symptoms of autonomic nervous system, meaning that her heart rate and blood pressure increase when she is just standing. Went to the emergency room in late May or June for the same kind of symptoms and finally they told her we just do not know the reason for this and was recommended eastern medicine practices. The patient was getting medical massage treatments once a month. The patient was not diagnosed with Myocarditis but stated that it has not been ruled out. The patient was taking a water pill, and her blood pressure readings were much better. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ulcerative colitis flare up on 01-AUG-2021, and loss of appetite, and shortness of breath, was recovering from high blood pressure spikes 3-4 times a week, dizziness and lightheadedness, and heart rate started racing, and had not recovered from insomnia, and legs feel weird sometimes (tingling at night). This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20211009555-COVID-19 VACCINE AD26.COV2.S-high blood pressure spikes 3-4 times a week. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211009555-COVID-19 VACCINE AD26.COV2.S-ulcerative colitis flare up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Other Meds:

Current Illness: Ulcerative colitis

ID: 1789870
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 202107; Test Name: Acoustic stimulation tests; Result Unstructured Data: baby passed the hearing test; Test Date: 202107; Test Name: Cardiac function test; Result Unstructured Data: issue with baby heart, Holes present; Test Date: 202109; Test Name: Cardiac function test; Result Unstructured Data: Holes closed

Allergies:

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

Symptoms: ISSUE WITH BABYS HEART HOLES PRESENT; INFANT DELIVERED AT 35 WEEKS AND 2 DAYS; PROBLEMS WITH BREATHING; REFLUX; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned an 8 week old female. The patient was enrolled in a non-company sponsored prorgam. The patient's weight was 11.2 pounds, and height was not reported. The patient's pre-existing medical conditions included: mother did not use drugs for recreational use, tobacco or alcohol during pregnancy. The patient has not been diagnosed with any genetic or inherited disorder. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: unknown) dose was not reported. On 24-Mar-2021, at gestational age 20 weeks and five days, the mother of the neonate received the Janssen or Johnson & Johnson(Ad26.COV2-S) vaccine for the prevention of COVID-19. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included docosahexaenoic acid, insulin aspart, insulin detemir, labetalol, nifedipine, and saccharated iron oxide. On 24-MAR-2021, the patient experienced cardiac septal defect, and was hospitalized (date unspecified). The patient delivered infant. On 24-MAR-2021, the patient experienced neonatal dyspnoea. On 24-MAR-2021, the patient experienced gastrooesophageal reflux disease. On 24-MAR-2021, the patient experienced foetal exposure during pregnancy. On an unspecified date in Jul-2021, the neonate underwent heart screening test which showed two holes in the heart. Laboratory data included: Acoustic stimulation tests (NR: not provided) baby passed the hearing test, and Cardiac function test (NR: not provided). On an unspecified date in SEP-2021, Laboratory data included: Cardiac function test (NR: not provided) Holes closed. On 04-SEP-2021, treatment medications included: lansoprazole. On an unspecified date in Sep-2021, during two-month check-up, it was confirmed that the holes in the baby's heart closed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the issue with baby's heart holes present, infant delivered at 35 weeks and 2 days, problems with breathing, reflux and foetal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and issue with baby's heart holes present, infant delivered at 35 weeks and 2 days, problems with breathing, reflux, and foetal exposure during pregnancy was not related. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210800681.; Sender's Comments: V0: 20211009718-covid-19 vaccine ad26.cov2.s ?Issues with baby's heart holes present, problems with breathing, reflux. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211009718-covid-19 vaccine ad26.cov2. s.-Foetal exposure during pregnancy, and Infant delivered at 35 weeks and 2days. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.

Other Meds: LABETALOL; PROCARDIA [NIFEDIPINE]; NOVOLOG; LEVEMIR; PRENATAL DHA; VENOFERRUM [SACCHARATED IRON OXIDE]

Current Illness:

ID: 1789871
Sex: M
Age:
State:

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 10/16/2021
Hospital: Y

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 Date: 202108; Test Name: Cardiac function test; Result Unstructured Data: heart is fine; Comments: baby's heart is fine; Test Date: 202108; Test Name: Acoustic stimulation tests; Result Unstructured Data: passed; Comments: baby passed the hearing test

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: PROBLEMS WITH BREATHING; BIRTH AT GESTATIONAL AGE 36 WEEKS AND TWO DAYS; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer (parent) concerned a male neonate. The patient was enrolled in a non-company sponsored study. The patient's weight was 2.92 kilograms, and height was 18 inches (as reported on 16-Aug-2021). The patient's parent's medical history Maternal obstetrical history included two previous pregnancies; one resulting in a live baby, while the outcome for the other pregnancy was not reported. The estimated delivery date (EDD) was reported to be 11-Sep-2021. Type of pregnancy was reported as a singleton, mother had history of anxiety and attention deficit disorder while, no history of tobacco, recreational drug, or alcoholic beverage consumption. On unknown dates, the mother of the neonate had blood tests, such as cell-free DNA screening, alfa fetoprotein, or the quad screen and a nuchal translucency screen test. None of the results showed any problem or concern. The patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 for covid-19 immunisation. The patient (baby) received it via foetal exposure (foetal exposure during pregnancy). Maternal concomitant medications included Prozac (fluoxetine hydrochloride), Unisom Sleep (doxylamine succinate) and Prenatal Plus (minerals nos/vitamins nos). The mother vaginally delivered a live, pre-term, male neonate. The mother of the neonate spent two days in the hospital for the delivery. The neonate's birth weight was 6 pounds and 7 ounces, body length was 18 inches. The neonate spent more than 10 days in the hospital after birth and was in the neonatal intensive care unit (NICU). On an unknown date on AUG-2021, laboratory data included: Acoustic stimulation tests (NR: not provided) showed baby passed the hearing test and Cardiac function test (NR: not provided) showed baby's heart was fine. The discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problems with breathing, birth at gestational age 36 weeks and two days and foetal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, birth at gestational age 36 weeks and two days, and foetal exposure during pregnancy as not related. The Company causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, birth at gestational age 36 weeks and two days, and foetal exposure during pregnancy was not related. This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210728727.; Sender's Comments: V0: 20211011488-Covid-19 vaccine ad26.cov2.s-3.Fetal exposure during pregnancy . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20211011488-Covid-19 vaccine ad26.cov2.s-2. Problems with breathing as not related . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS.

Other Meds: PROZAC; UNISOM SLEEP

Current Illness:

ID: 1789872
Sex: M
Age:
State: DE

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

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: LUNGS ARE STIFFENING (ACUTE RESPIRATORY DISTRESS SYNDROME); PATIENT PLACED ON VENTILATOR; SUSPECTED COVID-19 INFECTION/BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) 1 total, dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (breakthrough infection, dying in intensive care unit) (ICU). On unspecified date, the patient experienced lungs are stiffening (Acute respiratory distress syndrome) from the ventilator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, lungs are stiffening (Acute respiratory distress syndrome) from the ventilator and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000196340.; Sender's Comments: V0: 20211011489-covid-19 vaccine ad26.cov2.s-lungs are stiffening (Acute respiratory distress syndrome), Patient placed on ventilator, suspected covid-19 infection/ breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211011489-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

Date Died:

ID: 1789873
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; THROMBOCYTOPENIA; This spontaneous report was received from literature with VITT following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. Blood advances. 29-SEP-2021. This report concerned multiple patients (3) of unspecified age, sex, race and ethnic origin. The objective of this literature was to describe vaccine-induced immune thrombotic thrombocytopenia (VITT) following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. No past medical history or concurrent conditions were reported. The patients (over 8.7 million) received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, 3 patients (11 percent) experienced vaccine induced immune thrombotic thrombocytopenia (thrombosis) and thrombocytopenia following vaccination. On an unspecified date, unfortunately the patients died. It was not specified whether patients autopsy were performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of vaccine induced immune thrombotic thrombocytopenia (thrombosis) and thrombocytopenia on an unspecified date. The author commented that this literature highlighted the critical importance of knowing Covid-19 vaccine history. The author emphasized as on timely recognition that would be essential to prevent catastrophic complications and would require knowing the patient's vaccine history. This report was serious (Death). This case, from same literature article was linked to 20211004121 and 20211006771.; Sender's Comments: V0: 20211011609- COVID-19 VACCINE AD26.COV2.S- Vaccine induced immune thrombotic thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; THROMBOCYTOPENIA

Other Meds:

Current Illness:

ID: 1789874
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 09/06/2021
Rec V Date: 10/16/2021
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: BELL'S PALSY; SWOLLEN LIPS; SWELLING INSIDE MOUTH; SWOLLEN FACE AND JAW; SWOLLEN LEFT AND RIGHT EYE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose was not reported, 1 total administered at left arm on15-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-SEP-2021, the patient experienced her whole face and left eye was swollen and described it as total distortion. Her face was huge. she went to the doctor but doctor did not know what it was and thought it was allergic reaction so patient did some research and On an unspecified date, she thought she was having bell's palsy from the vaccine. They gave her shot and put her on steroids patient was fine after 24 to 36 hours. On 05-OCT-2021, patient experienced her face started to swell up again and also her right eyes was swollen. On 06-OCT-2021, the patient experienced swelling came down to her jaw, lips and inside of the mouth. swollen lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen face and jaw, swollen left and right eye, swollen lips, and swelling inside mouth, and the outcome of bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211011928-COVID-19 VACCINE AD26.COV2.S-bell's palsy, swollen face and jaw, swollen left and right eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Allergy

ID: 1789875
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 07/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: PAIN IN RIBS (RIBS STILL HURTING UPON AWAKENING); ENTIRE BODY BLOATED; NERVES ON EDGE TRIGGERING AND FIRING; NECK PAIN; BODY HURTING, PAIN BEHIND RIGHT EAR; MIGRAINES (PAIN IN HEAD); SCARY FEELING; WEAK; FEEL EXHAUSTED; HAIR FALLEN / HAIR THIN; PAIN IN BACK OF RIGHT LEG ARM LEFT ARM, BIG TOE AND TOENAIL HURTING; DOUBLE VISION; FEEL LIKE GOING TO BLIND; COLD; DRY EYES (EYES PAIN, BLURRED VISION); LEFT HIP AND SHOULDER PAIN, ANKLE PAIN; ENTIRE BODY SWOLLEN (NECK SWELLING, LEG/ANKLE SWOLLEN UP, RIBS VERY SWOLLEN); SMALL RED BLOTCHES UNDER BRA, ON CENTER OF BACK ON LEFT SIDE (3 AREAS STRAIGHT ACROSS); BOTH ARMS HORRIBLY RED (ARM IS A RED-PURPLISH COLOUR), BACK OF HEAD, NECK AND SPINAL ON THE RIGHT SIDE FEELS WEIRD AND GETS PINK; FELT DIZZY / FEELING FAINT / FELT LIKE IF STOOD WOULD PASS OUT; COULD NOT WALK STRAIGHT; TWITCHING IN LEFT EYE; FELT LIKE FALLING OVER / ALMOST FELL; FUNNY FEELING IN THE HEAD / BITING FEELING IN THE CENTER OF THE BACK ON SPINAL COLUMN / FEELS LIKE KINK ON BACK OF HEAD AND SHOULDER/ WEIRD FEELING, FEEL LIKE IN VACCUM; LEFT ARM, LEGS AND ANKLES NUMB; CRAWLING SENSATION IN HEAD, SCALP AND ARMS; LEFT ARM SWOLLEN ABOVE THE WRIST, LEGS AND ANKLES SWOLLEN; TINGLING IN PINKY FINGER, RING FINGER, LEG , ANKLES AND LEFT ARM / PINS NEEDLLE SENSATION IN NECK, ARM; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included: removed parotid gland on right side., and concurrent conditions included: rectal cancer right on stage 4, chemotherapy for rectal cancer, lung cancer both left and right side, radiation for lung cancer, tongue cancer, buccal cancer, pre-ca right parotid and half salivary gland, skin cancer, and fright, and other pre-existing medical conditions included: Patient sees massage therapist on a monthly basis. Patient was on homeopathic Aconite for fright medication, 30c. for approximately 30 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 28-JUL-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the patient experienced left arm swollen above the wrist, legs and ankles swollen. On 28-JUL-2021, the patient experienced tingling in pinky finger, ring finger, leg, ankles and left arm / pins needle sensation in neck, arm. On 29-JUL-2021, the patient experienced crawling sensation in head, scalp and arms. On 30-JUL-2021, the patient experienced felt dizzy / feeling faint / felt like if stood would pass out. On 30-JUL-2021, the patient experienced could not walk straight. On 30-JUL-2021, the patient experienced twitching in left eye. On 30-JUL-2021, the patient experienced felt like falling over / almost fell. On 30-JUL-2021, the patient experienced funny feeling in the head / biting feeling in the center of the back on spinal column / feels like kink on back of head and shoulder/ weird feeling, feel like in vaccum. On 30-JUL-2021, the patient experienced left arm, legs and ankles numb. On 03-AUG-2021, the patient experienced both arms horribly red (arm is a red-purplish color), back of head, neck and spinal on the right side feels weird and gets pink. On 03-AUG-2021, the patient experienced small red blotches under bra, on center of back on left side (3 areas straight across). On 10-AUG-2021, the patient experienced entire body swollen (neck swelling, leg/ankle swollen up, ribs very swollen). On 12-AUG-2021, the patient experienced dry eyes (eyes pain, blurred vision). On 12-AUG-2021, the patient experienced left hip and shoulder pain, ankle pain. On 16-AUG-2021, the patient experienced cold. On 21-AUG-2021, the patient experienced feel like going to blind. On 21-AUG-2021, the patient experienced double vision. On 22-AUG-2021, the patient experienced pain in back of right leg arm left arm, big toe and toenail hurting. On 01-SEP-2021, the patient experienced hair fallen / hair thin. On an unspecified date, the patient experienced pain in ribs (ribs still hurting upon awakening), entire body bloated, nerves on edge triggering and firing, neck pain, body hurting, pain behind right ear, migraines (pain in head), scary feeling, weak, and feel exhausted. Treatment medications (dates unspecified) included: olopatadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crawling sensation in head, scalp and arms on AUG-2021, and double vision on 21-AUG-2021, had not recovered from feel exhausted, hair fallen / hair thin, pain in ribs (ribs still hurting upon awakening), dry eyes (eyes pain, blurred vision), weak, felt dizzy / feeling faint / felt like if stood would pass out, could not walk straight, twitching in left eye, funny feeling in the head / biting feeling in the center of the back on spinal column / feels like kink on back of head and shoulder/ weird feeling, feel like in vaccum, and entire body swollen (neck swelling, leg/ankle swollen up, ribs very swollen), and the outcome of pain in back of right leg arm left arm, big toe and toenail hurting, left arm, legs and ankles numb, entire body bloated, both arms horribly red (arm is a red-purplish color), back of head, neck and spinal on the right side feels weird and gets pink, tingling in pinky finger, ring finger, leg , ankles and left arm / pins needle sensation in neck, arm, left arm swollen above the wrist, legs and ankles swollen, nerves on edge triggering and firing, cold, neck pain, body hurting, pain behind right ear, migraines (pain in head), felt like falling over / almost fell, small red blotches under bra, on center of back on left side (3 areas straight across), left hip and shoulder pain, ankle pain, scary feeling and feel like going to blind was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure, as the case is assessed as non serious.

Other Meds:

Current Illness: Buccal cavity cancer; Carcinoma of tongue; Chemotherapy; Fear (homeopathic Aconite 30c for approximately 30 years); Lung cancer; Malignant neoplasm of parotid gland (Parotid gland has been removed on right side.); Radiation therapy; Rectal cancer stage IV (on chemo); Skin cancer

ID: 1789876
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Optical coherence tomography; Result Unstructured Data: Acute Macular Neuroretinopathy; Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Name: Fundus autofluorescence; Result Unstructured Data: lesions in right eye; Test Name: Slit-lamp examination; Result Unstructured Data: unremarkable in both eyes; Test Name: Ophthalmoscopy normal; Result Unstructured Data: unremarkable in both eyes; Test Name: Visual acuity tests; Result Unstructured Data: 20/20 in both eyes

Allergies:

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

Symptoms: ACUTE MACULAR NEURORETINOPATHY; This spontaneous report was received from literature. This report concerned a 26 year old female. The objective of this study was to present the rare case of a patient who developed acute macular neuroretinopathy following administration of a single dose adenovector coronavirus vaccine The patient's height, and weight were not reported. The patient's other pre-existing medical conditions included: Patient was healthy female with no previous medical or ocular history. Patient had previously received seasonal influenza immunization without any symptoms and denied any recent history of viral illnesses. Patient denied any other medication use or recent changes in diet and she also denied any history of hypertension, trauma, hypovolemia, or epinephrine use. The patient took oral contraceptives (for past 8 years). The patient was previously treated with diphtheria vaccine toxoid/hib vaccine/pertussis vaccine/tetanus vaccine toxoid for immunization. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient presented with a five day history of paracentral scotomas in both eyes. Patient reported that she received a single dose adenovector coronavirus vaccine two days prior to the onset of her symptoms. On examination, her best-corrected visual acuity was 20/20 in both eyes. It was reported that there was no afferent pupillary defect, and intraocular pressure was 18 in the right eye and 15 in the left eye. Slit-lamp biomicroscopy and ophthalmoscopic examination were unremarkable in both eyes. Fundus autofluorescence showed petalloid faintly hypoautofluorescent lesions in the right eye, while the left eye appeared normal. Spectral domain optical coherence tomography revealed focal areas of parafoveal hyperreflective bands in the outer retina in both eyes without retinal thickening. Near-infrared reflectance showed wedge-shaped parafoveal lesions pointing to the fovea that corresponded to these lesions. It was reported that the imaging findings were consistent with acute macular neuroretinopathy, and conservative management was recommended. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute macular neuroretinopathy was not reported. Authors discussed the development of acute macular neuroretinopathy after a SARS-CoV-2 vaccination in an otherwise healthy female patient. A single case cannot establish cause and effect, and millions of COVID-19 vaccines have been administered safely at the time of writing. However, this may be a rare association, and clinicians can consider inquiring about recent vaccination history in patients presenting with acute macular neuroretinopathy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211012947- Covid-19 vaccine ad26.cov2.s-Acute macular neuroretinopathy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1789877
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 10/16/2021
Hospital: Y

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: BLOOD CLOT; HEMORRHAGE IN BRAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was admitted to the hospital and on 22-SEP-2021, she was found to have a blood clot with hemorrhage in the brain. The reporter stated that the patient remained sedated by in stable condition but had at least three surgeries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot, and hemorrhage in brain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211014208-COVID-19 VACCINE AD26.COV2.S-blood clot, hemorrhage in brain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1789878
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Comments: The patient was clinically confirmed with COVID-19 diagnosis on 12-SEP-2021 via nasal swab.

Allergies:

Symptom List: Tremor

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; LITTLE ACHE-Y; LITTLE BIT OF A SORETHROAT; TIRED; This spontaneous report received from a patient concerned a 56 year old female of an unspecified ethnic origin. The patient's weight was 215 pounds, and height was 62 inches. The patient's past medical history included: heart attack, and transient ischaemic attack (TIA), and concurrent conditions included: non alcoholic, non smoker, and hypertension (HTN). The patient had no drug abuse or illicit usage. The patient experienced drug allergy when treated with acetylsalicylic acid (ASA) used for unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1437217 or 143A21A, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included statins and Plavix (clopidogrel bisulfate) for heart attack, and blood pressure medications for hypertension. On 07-APR-2021, the patient was tired, little ache-y and had a little bit of sore throat for about a week. On 08-SEP-2021, patient started feeling sick (tired, achy, sore throat)- covid-19 infection. On 12-SEP-2021, patient underwent a nasal swab test (COVID-19 virus test) which came positive and patient was clinically confirmed with COVID-19 diagnosis (suspected clinical vaccination failure). All of these symptoms had resolved but a little tiredness was persistent. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little ache-y, little bit of a sore throat and tired on APR-2021, was recovering from covid-19 infection- feeling sick (tired, achy, sore throat), and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.; Sender's Comments: V0:20211014275-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: PLAVIX

Current Illness: Abstains from alcohol; Hypertension; Non-smoker

ID: 1789879
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210927; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: 1.5

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: LOW ANTIBODIES AGAINST COVID VIRUS; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: 23-AUG-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced low antibodies against covid virus. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) 1.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low antibodies against covid virus was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1789880
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 10/16/2021
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: HANDS PEELING; SALT WATER POOL CAUSED HANDS TO BLEED; HAD A PRETTY TERRIBLE EXPERIENCE WITH A BAD SKIN REACTION; HANDS CRACKING; RASH ON HANDS; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not mention any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 185029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced hands peeling. On MAR-2021, the patient experienced salt water pool caused hands to bleed. On MAR-2021, the patient experienced had a pretty terrible experience with a bad skin reaction. On MAR-2021, the patient experienced hands cracking. On MAR-2021, the patient experienced rash on hands. Treatment medications (dates unspecified) included: mineral oil light/paraffin/petrolatum/wool alcohols. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a pretty terrible experience with a bad skin reaction, rash on hands, hands cracking, hands peeling and salt water pool caused hands to bleed was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1789881
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: STROKE; BLOOD CLOT; OUT OF HIS GOURD; This spontaneous report received from a consumer concerned a 7 decade old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose were not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced stroke, blood clot. As per reporter, patient was out of his gourd, but at the time of reporting patient was some what normal but patient would never be normal and also stated that the Janssen COVID-19 vaccine was 2 doses of mRNA. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot, stroke, and out of his gourd. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211014628 and 20211014552.; Sender's Comments: V0: 20211014652-covid-19 vaccine ad26.cov2.s-stroke, blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1789882
Sex: M
Age:
State: PA

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

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: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned an 84 year old male. The patient's height, and weight were not reported. The patient's past medical history included: heart surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection (breakthrough infection), and suspected clinical vaccination failure, and was hospitalized (date and days unspecified). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The day before reporting the patient's lungs were clear and had no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000196454.; Sender's Comments: V0: 20211014653-COVID-19 VACCINE AD26.COV2.S-Suspected covid-19 infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211014653-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1789883
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/20/2021
Rec V Date: 10/16/2021
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: RIGHT SIDE SWELLING BY RIB CAGE; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines. Manufacturer Receipt Date: 07-OCT-2021 A clinical investigator reported that a patient of unspecified age and sex (subject number and site number were not reported) experienced grade 1 right side swelling by rib cage (PT: swelling). The event occurred unknown days after COVID-19 vaccine Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with study vaccine was not applicable. The outcome was recovering. The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported. On an unknown date, the subject was treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported. On 20-JUL-2021, the subject experienced right side swelling by rib cage. The outcome of erythema was recovering. Investigator's causality assessment: The event of swelling was not related to the study vaccine. Company causality assessment: The event of swelling was not related to the study vaccine.

Other Meds:

Current Illness:

ID: 1789884
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
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: POSSIBLE CONCUSSION; EXPIRED VACCINE ADMINISTERED; SEIZURE; HIT HEAD REQUIRING STAPLES; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not had any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 22-MAR-2021) dose was not reported, 1 total, administered on 06-OCT-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, after vaccination, patient went to wait the 15 minutes in his car but came back into the pharmacy. The patient did not look good according to the technician who approached patient. Patient was began to speak then went down (passed out) and hit his head and did not seem to be breathing and one of the pharmacists went to give cardiopulmonary resuscitation (CPR) when patient gasped for air. Patient had labored breathing and had a seizure at that time for which he was taken to emergency room. It was stated that the patient was fine when he first came into the pharmacy to get the vaccine. On the same day, as per reporter, the patient and his mom came into the pharmacy and at that time patient did have some staples put into his head because he hit his head when he went down. Patient received expired vaccine on same day. On 07-OCT-2021, patient had a headache, nauseous and was resting. As per reporter, patient might have a concussion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hit head requiring staples, and seizure, had not recovered from possible concussion, and the outcome of expired vaccine administered was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211015018-COVID-19 VACCINE AD26.COV2.S-Seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1789885
Sex: F
Age:
State: IN

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: HAVING UNDERLYING PNEUMONIA; This spontaneous report received from a health care professional concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: pulmonary arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, Expiry: Unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. Concomitant medications included Macitentan for pulmonary arterial hypertension. The batch number was not reported and has been requested. The patient was hospitalized (date unspecified) and having underlying pneumonia. She was unaware that having underlying pneumonia. She stated that had no side effects from the medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having underlying pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211015035-covid-19 vaccine ad26.cov2.s-having underlying pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: Opsumit

Current Illness: Pulmonary arterial hypertension.

ID: 1789886
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210927; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Name: Body temperature; Result Unstructured Data: 105 F; Test Name: Oxygen saturation; Result Unstructured Data: 90 %, Went down to 90 percent

Allergies:

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

Symptoms: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous potential legal report received from a patient concerned a 53 year old white male of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Non alcohol user, and non smoker. The patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient felt very sick and went to a drive to get tested for COVID 19 test and results came back positive. The patient stated that he had horrific symptoms such as 105 Fahrenheit (F) fever for five days. The patient stated he was about to go to the hospital and his oxygen levels went down to 90 percent (confirmed covid-19 infection and confirmed clinical vaccination failure). As per the report, the patient had clinically confirmed COVID 19 infection more than 28 days post vaccination. Treatment medications included: Aleve (naproxen sodium). As per the report, the patient felt little better however still was coughing. The patient was very upset and stated that the vaccine did not help him at all but made things worse for him. The patient mentioned that his friend who was not vaccinated was having less severe symptoms with COVID 19 than him. The patient was questioning about vaccine and said was it just water because it did not work at all. The patient stated as his physician was aware of his symptoms and was disturbed and told to the patient that he (physician) had been hearing lot of similar cases. The patient stated he was otherwise healthy, and no health conditions, had no flu in 20 years. As per the report the patient stated that he did not want to give any additional information now until he speaks with his attorney. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number was requested.; Sender's Comments: V0: 20211015070-Covid-19 vaccine - confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1789887
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 05/22/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VACCINE EXPOSURE VIA BREAST FEEDING; This spontaneous report received from a parent via a (VAERS- Vaccine Adverse Event Reporting System) (VAERS ID: 1714945) concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 22-MAY-2021, the patient experienced vaccine exposure via breast feeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast feeding was not reported. This report was non-serious. This parent/child case is linked to 20211009578.

Other Meds:

Current Illness:

ID: 1789888
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Guillain barre syndrome (previously had experienced when she was 19 and 40 years old). Patient was with a group of 14 whom all tested positive for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-SEP-2021, patient experienced sore throat. On 06-OCT-2021, she lost her taste and smell and received the regeneron monoclonal antibody (IV treatment). On an unspecified date, she tested positive for covid-19 infection (coded to suspected covid-19 infection) and also experienced suspected clinical vaccination failure but was not hospitalised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196465.; Sender's Comments: V0: 20211015230-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20211015230-covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Other Meds:

Current Illness: Guillain-Barre syndrome (Has had a history of GBS twice when patient was 19 and when she was 40 years of age.)

ID: 1789889
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/20/2021
Rec V Date: 10/16/2021
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: INSOMNIA; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines. Manufacturer Receipt Date: 07-OCT-2021 A clinical investigator reported that a patient of unspecified age and sex (subject number and site number were not reported) experienced grade 2 insomnia. The event occurred unknown days after COVID-19 vaccine Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with study vaccine was not applicable. The outcome was recovered. The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported. On an unknown date, the subject was treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported. On 20-JUL-2021, the subject experienced insomnia. On 24-JUL-2021, the subject recovered from insomnia. Investigator's causality assessment: The event of insomnia was possible to the study vaccine. Company causality assessment: The event of insomnia was possible to the study vaccine.

Other Meds:

Current Illness:

ID: 1789890
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/24/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: LOWER BACK PAIN; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines. Manufacturer Receipt Date: 07-OCT-2021 A clinical investigator reported that a patient of unspecified age and sex (subject number and site number were not reported) experienced grade 1 lower back pain. The event occurred unknown days after COVID-19 vaccine Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with study vaccine was not applicable. The outcome was recovering. The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported. On an unknown date, the subject was treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported. On 24-JUL-2021, the subject experienced lower back pain due to an exercise related injury. The subject was recovering from lower back pain. Investigator's causality assessment: The event of back pain was not related to the study vaccine. Company causality assessment: The event of back pain was not related to the study vaccine.

Other Meds:

Current Illness:

ID: 1789891
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/23/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Right axillary swelling and soreness; This report received from a business partner via clinical trial 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines, (subject number and site number were not reported). The subject's weight, height, and medical history were not reported. The subject initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, the subject experienced right axillary swelling and soreness. The dose of covid-19 vaccine ad26.cov2.s was not changed. The subject was recovering from right axillary swelling and soreness. The investigator assessed the severity of right axillary swelling and soreness as grade 1 mild adverse event. The investigator considered the causality between covid-19 vaccine ad26.cov2.s and right axillary swelling and soreness as possible. This report was non-serious.

Other Meds:

Current Illness:

ID: 1789892
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/22/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: DIZZINESS; This report received from a business partner via clinical trial 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines, (subject number and site number were not reported). The subject's weight, height, and medical history were not reported. The subject initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 22-JUL-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The subject recovered from dizziness on 23-JUL-2021. The investigator assessed the severity of dizziness as grade 2 moderate adverse event. The investigator considered the causality between covid-19 vaccine ad26.cov2.s and dizziness as possible. This report was non-serious.

Other Meds:

Current Illness:

ID: 1789893
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 104

Allergies:

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

Symptoms: NEARLY DIED; MEDICATION ERROR; FEVER OF 104; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced nearly died, medication error, and fever of 104. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 104, and the outcome of nearly died and medication error was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.

Other Meds: BNT 162

Current Illness:

ID: 1789894
Sex: F
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: IMMUNE COMPROMISED ISSUES; DIFFICULTY BREATHING; LIGHT HEADED ALMOST PASSED OUT (DIZZINESS); HEART RACING; THROAT FELT LIKE IT WAS GOING TO CLOSE UP; DYING; WEAKNESS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included: seizures, and concurrent conditions included: coconut allergy, and immune compromised, and other pre-existing medical conditions included: Patient had many illness and she was on end stage and dying. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported,1 total, administered to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was dying and had all kinds of immune compromised issues and one day after vaccination, at around 21:00, she was in the back of the bathroom and felt like she was going to pass out (light headed, dizziness), she hollard for her husband and he got her to the chair (weakness). She stated that she ended up with all serious side effects except all over rash. Her heart was racing, her throat felt like it was going to close up like it did when she had coconut. She had difficulty breathing and went to the Emergency room (ER) and was discharged the same night. Her husband put her in bed and watched her overnight to make sure she was ok. She was abused, raped, had seizures, been institutionalized for speaking about God and was going paralyzed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, light headed almost passed out (dizziness), heart racing, weakness, and throat felt like it was going to close up, and the outcome of immune compromised issues and dying was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20211016208-covid-19 vaccine ad26.cov2.s- Immune compromised issues. This event(s) is considered not related. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Other Meds:

Current Illness: Food allergy; Immunosuppression NOS

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am