VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1751690
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: look at testimonials on here of how it doesn't prevent you from getting shingles/Suspected vaccination failure; look at testimonials on here of how it doesn't prevent you from getting shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included taste disorder (refer case US2021AMR203490) and smell loss (refer case US2021AMR203490). 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. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. As per the patient, look at testimonials on here of how it did not prevent you from getting shingles. The patient was injured from the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR203490:Same reporter, same patient, different event

Other Meds:

Current Illness:

ID: 1751691
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: had the shot and he get shingles/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 male 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 reported as follows; The case was reported by the patient's sister in law. The age at vaccination was not reported. The reporter said generally that shot did not prevent the shingles just help you had a lighter case of the shingles. The patient had the shot and he still got the shingles just not as often. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1751695
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: Bell's Palsy; shingles; This case was reported by a consumer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the bell's palsy and shingles were unknown. It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had Bells palsy and had shingles 2 times post vaccination. The patient asked if anyone had the shot and still had shingles. The patient stated that he/she was not told anything about needing the 2nd shot.

Other Meds:

Current Illness:

ID: 1751696
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: had shingles after I had the vaccine/ suspected vaccination failure; shingles; nerve pain; painful; 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), shingles, nerve pain and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the nerve pain was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and pain to be related to Shingles vaccine. Additional information was provided as follows: The age at vaccination was not reported. The patient had shingles after vaccination. The patient had nerve pain in the area of the shingles at the time of reporting. The reporter stated they were painful and took several weeks to heal. The patient had the vaccination when it was first was available and he was told that the new one was better. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1751697
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: have the new vaccine and still got the shingles/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 patient self-reported this case. The age at vaccination was not reported. The patient had new vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1751698
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: The vaccine help but his will have it/suspected vaccination failure; has it on the optic nerve of his eye; doesn't feel well; stress; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included ophthalmic herpes zoster (had it for over 30 years). 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), ophthalmic herpes zoster (serious criteria GSK medically significant), feeling unwell and stress. On an unknown date, the outcome of the vaccination failure, feeling unwell and stress were unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, feeling unwell and stress to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient got the shingles on the optic nerve of his eye and had it for over 30 years. It comes on when patient doesn't feel well or was under a lot of stress. The vaccine had helped the severity, but would always have it. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1751699
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: It hurts like hell and I had the shot/ suspected vaccination failure; It hurts like hell and I had the shot; hurts; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot years ago and still got shingles. The patient stated that the shingles hurt like hell. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1751707
Sex: M
Age: 15
State: VA

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 10/01/2021
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: administered infanrix /Date of birth Mar 12th 2006; administered infanrix /Date of birth Mar 12th 2006; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-year-old male patient who received DTPa (Infanrix) (batch number 49TN3, expiry date 28th May 2022) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 25th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 25th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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 reported as follows: A health care professional administered infanrix to a patient when Boostrix was the vaccine indicated for the patient which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 7 case reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021201380:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter US-GLAXOSMITHKLINE-US2021201378:same reporter US-GLAXOSMITHKLINE-US2021201377:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter US-GLAXOSMITHKLINE-US2021201375:same reporter

Other Meds:

Current Illness:

ID: 1751709
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: Flulaval to be stored at temperature below what is recommended; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Tetra) 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 and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra and Flulaval Tetra 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 reporter stated that the Flulaval was stored at temperature below what was recommended, which led to incorrect storage of drug. The pharmacist did administer the suspect Flulaval to patients. The reporter did not consent to follow-up. No additional information was provided.

Other Meds:

Current Illness:

ID: 1751714
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: after vaccine series, recurrent shingles/ suspected vaccination failure; recurrent shingles, lower back; recently was diagnosed with chickenpox/chickenpox after getting the Shingrix vaccine; Genital lesions; Painful; Constipation; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, chickenpox, genital lesion, pain and constipation. The patient was treated with linaclotide (Linzess) and acyclovir. On an unknown date, the outcome of the vaccination failure, chickenpox and pain were unknown and the outcome of the shingles was recovering/resolving and the outcome of the genital lesion and constipation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, chickenpox, genital lesion, pain and constipation to be related to Shingrix and Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that after receiving the Shingrix vaccine series, she developed genital lesions, recurrent shingles outbreaks on lower back, that was painful, and began having constipation. The patient was prescribed acyclovir for the genital lesions and lower back. Linzess was also prescribed to patient by healthcare professional for constipation. The patient also disclosed that she recently was diagnosed with chickenpox by her healthcare professional. The patient's healthcare professional referred patient to dermatologist and the patient had not yet seen dermatologist but planned to. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1751724
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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 Name: alanine aminotransferase; Result Unstructured Data: (Test Result:124,Unit:u/L,Normal Low:30,Normal High:65); Test Name: aspartate aminotransferase; Result Unstructured Data: (Test Result:299,Unit:u/L,Normal Low:15,Normal High:37); Test Name: adrenocorticotropic hormone; Result Unstructured Data: (Test Result:more than 2000,Unit:pg/mL,Normal Low:7.2,Normal High:63.3); Test Name: adrenocorticotropic hormone; Result Unstructured Data: (Test Result:elevated,Unit:pg/mL,Normal Low:7.2,Normal High:63.3); Test Name: cortisol; Result Unstructured Data: (Test Result:0.69,Unit:mcg/dl,Normal Low:4.3,Normal High:22.4); Test Name: Blood cultures; Result Unstructured Data: (Test Result:did not grow any organisms,Unit:unknown,Normal Low:,Normal High:); Test Name: potassium; Result Unstructured Data: (Test Result:6.2,Unit:mmol/L,Normal Low:3.5,Normal High:5.1); Test Name: blood pressure; Result Unstructured Data: (Test Result:90/60,Unit:mmHg,Normal Low:,Normal High:); Test Name: sodium; Result Unstructured Data: (Test Result:102,Unit:mmol/L,Normal Low:136,Normal High:145); Test Name: total testosterone; Result Unstructured Data: (Test Result:total testosterone was 200,Unit:ng/dL,Normal Low:264,Normal High:916); Test Name: total testosterone; Result Unstructured Data: (Test Result:decreased,Unit:ng/dL,Normal Low:264,Normal High:916); Test Name: free testosterone; Result Unstructured Data: (Test Result:0.8,Unit:pg/mL,Normal Low:9.3,Normal High:26.5); Test Name: free testosterone; Result Unstructured Data: (Test Result:decreased,Unit:pg/mL,Normal Low:9.3,Normal High:26.5); Test Name: thyroid-stimulating hormone; Result Unstructured Data: (Test Result:5.25 micro,Unit:iu/ml,Normal Low:0.36,Normal High:3.74); Test Name: thyroid-stimulating hormone; Result Unstructured Data: (Test Result:elevated,Unit:iu/ml,Normal Low:0.36,Normal High:3.74); Test Name: CT abdomen; Result Unstructured Data: (Test Result:no gross adrenal enlargement or abnormalities,Unit:unknown,Normal Low:,Normal High:); Test Name: dehydroepiandrosterone sulfate; Result Unstructured Data: (Test Result:less than 15,Unit:mcg/dl,Normal Low:80.0,Normal High:560.0); Test Name: dehydroepiandrosterone sulfate; Result Unstructured Data: (Test Result:decreased,Unit:mcg/dl,Normal Low:80.0,Normal High:560.0); Test Name: hemoglobin; Result Unstructured Data: (Test Result:16.9,Unit:g/dL,Normal Low:13.7,Normal High:17.5); Test Name: heart rate; Result Unstructured Data: (Test Result:30,Unit:beats/min,Normal Low:,Normal High:); Test Name: 21-hydroxylase antibodies; Result Unstructured Data: (Test Result:21-hydroxylase was 40 U/,Unit:/ml,Normal Low:less than 1,Normal High:); Test Name: 21-hydroxylase antibodies; Result Unstructured Data: (Test Result:elevated,Unit:/ml,Normal Low:less than 1,Normal High:); Test Name: Laboratory test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: T4; Result Unstructured Data: (Test Result:1.62,Unit:ng/dL,Normal Low:0.89,Normal High:1.76); Test Name: urine analysis; Result Unstructured Data

Allergies:

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

Symptoms: Adrenal crisis; decreased appetite; decreased fluid intake; Lethargic; Cyanotic; bradycardic; low blood pressure; Cold; clammy skin; Skin mottled in color; Hyponatremia; Hyperkalemia; Hypothermia; low cortisol level; autoimmune Addison's disease; euthyroid sick syndrome; mid-abdominal discomfort; vomiting; tingling; numbness of feet and toes; generalized body aches; Fatigue; Malaise; This case was reported in a literature article and described the occurrence of adrenal crisis in a 21-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Co-suspect products included DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine and DTaP vaccine. On an unknown date, less than a week after receiving Influenza vaccine and DTaP vaccine, the patient experienced adrenal crisis (serious criteria hospitalization and GSK medically significant), general body pain (serious criteria hospitalization), fatigue (serious criteria hospitalization), malaise (serious criteria hospitalization), abdominal discomfort (serious criteria hospitalization), vomiting (serious criteria hospitalization), decreased appetite (serious criteria hospitalization), oligodipsia (serious criteria hospitalization), tingling (serious criteria hospitalization), numbness in feet (serious criteria hospitalization), lethargy (serious criteria hospitalization), cyanosis (serious criteria hospitalization), bradycardia (serious criteria hospitalization and GSK medically significant), low blood pressure (serious criteria hospitalization), cold (serious criteria hospitalization), clamminess (serious criteria hospitalization), mottled skin (serious criteria hospitalization), hyponatremia (serious criteria hospitalization), hyperkalemia (serious criteria hospitalization and GSK medically significant), hypothermia (serious criteria hospitalization and GSK medically significant), cortisol decreased (serious criteria hospitalization), addison's disease (serious criteria hospitalization and GSK medically significant) and euthyroid sick syndrome (serious criteria hospitalization). The patient was treated with ceftriaxone, dexamethasone, hydrocortisone and glucocorticoids nos (Glucocorticoid). On an unknown date, the outcome of the adrenal crisis, abdominal discomfort, decreased appetite, oligodipsia, lethargy, cyanosis, bradycardia, low blood pressure, cold, clamminess, mottled skin, hypothermia, addison's disease and euthyroid sick syndrome were unknown and the outcome of the general body pain, fatigue, malaise, vomiting, tingling, numbness in feet, hyponatremia and hyperkalemia were recovered/resolved and the outcome of the cortisol decreased was recovering/resolving. The reporter considered the adrenal crisis, general body pain, fatigue, malaise, abdominal discomfort, vomiting, decreased appetite, oligodipsia, tingling, numbness in feet, lethargy, cyanosis, bradycardia, low blood pressure, cold, clamminess, mottled skin, hyponatremia, hyperkalemia, hypothermia, cortisol decreased, addison's disease and euthyroid sick syndrome to be related to Influenza vaccine and DTaP vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of adrenal crisis (AC) in a 21-year-old male patient, who was vaccinated with unspecified Influenza vaccine and unspecified Diphtheria, Tetanus, and acellular Pertussis (DTaP) vaccine (manufacturer unknown) for prophylaxis. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified Influenza vaccine and unspecified Diphtheria, Tetanus, and acellular Pertussis (DTaP) vaccine (Route and site of administration unknown; batch number not provided; dosage unknown for both) in preparation for school. The age of vaccination was not provided. On an unspecified date, 1 week after the vaccination, the patient presented to the emergency room (ER) with complaints of generalized body aches, fatigue, and malaise for five days. The patient reported mid-abdominal discomfort associated with scant vomiting for two days with associated decreased appetite and fluid intake. The patient endorsed tingling and numbness of feet and toes for one day. The patient's family had brought the patient to the hospital as the patient had been lethargic and appeared cyanotic. The patient denied fever, chills, rash, joint swelling, joint pain, neck stiffness or pain, sore throat, sinus drainage or pressure, urinary complaints, or bowel changes. The patient also denied recent travel or sick contacts. In the ER, the patient was lethargic, bradycardic with a heart rate of 30 beats per minute and had low blood pressure at 90/60 mmHg. On examination, the patient had a cold, as well as clammy skin that was mottled in color. Initial laboratory testing at the time of admission showed hemoglobin was 16.9 g/dL (normal range: 13.7-17.5), sodium was 102 mmol/L (normal range: 136-145), potassium was 6.2 mmol/L (normal range: 3.5-5.1), aspartate aminotransferase (AST) was 299 U/L (normal range: 15-37) and alanine aminotransferase (ALT) was 124 U/L (normal range: 30-65). Additionally, the patient's urine analysis was unremarkable. The patient was transferred to the Intensive care unit (ICU) and started on fluids and given a prophylactic dose of ceftriaxone. A cortisol level was drawn, and the patient was given a dose of dexamethasone for the possibility of AC in light of concurrent hyponatremia, hyperkalemia, hypotension and hypothermia. The patient's blood pressure, heart rate, and coloration improved. Due to this positive response, the patient started on intravenous (IV) hydrocortisone. Subsequent laboratory testing showed cortisol was 0.69 mcg/dL (normal range: 4.3-22.4), adrenocorticotropic hormone (ACTH) was more than 2000 pg/mL (normal range: 7.2-63.3), dehydroepiandrosterone sulfate (DHEA) was less than 15 mcg/dL (normal range: 80.0-560.0), total testosterone was 200 ng/dL (normal range: 264-916), free testosterone was 0.8 pg/mL (normal range: 9.3-26.5), 21-hydroxylase was 40 U/mL (normal range: less than 1), thyroid-stimulating hormone (TSH) was 5.25 mcInU/mL (micro IU/mL) (normal range: 0.36-3.74) and T4 was 1.62 ng/dL (normal range: 0.89-1.76). The low cortisol level prior to the treatment combined with improvement in clinical status following glucocorticoid treatment was consistent with AC. Further diagnostic laboratory testing demonstrated an elevated Adreno corticotropic hormone (ACTH) along with a decreased dehydroepiandrosterone sulfate (DHEA), total testosterone, and free testosterone. 21-hydroxylase antibodies were elevated, consistent with autoimmune Addison's disease. Thyroid-stimulating hormone (TSH) was slightly elevated, with a normal T4, suggestive of euthyroid sick syndrome. CT abdomen done showed no gross adrenal enlargement or abnormalities. Blood cultures did not grow any organisms. With continued treatment with steroids, the patient's severe hyponatremia and other electrolyte abnormalities were corrected. The endocrinologist recommended starting the patient on maintenance mineralocorticoid on discharge. This case was considered as serious due to Hospitalization. The authors commented, "Our patient did not have a known history of AI prior to admission, nor did he endorse any symptoms prior to his vaccination. However, we speculate that our patient had underlying undiagnosed Adrenal insufficiency (AI). This may be attributed to the already vague symptoms of AI, such as fatigue, weight loss, and loss of appetite, which develop slowly over months. In itself, AI is fairly rare with studies reporting the prevalence ranging from 35-60 per million, thereby making the diagnosis easier to be overlooked. Patients with AI may go undiagnosed until they have significant stressors inducing an AC. In 70-90% of cases of AI, the primary etiology was determined to be autoimmune adrenalitis. As our patient had antibodies against 21-hydroxylase, we believe he had underlying autoimmune Addison's disease. It is important during the time of

Other Meds:

Current Illness:

ID: 1751725
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/15/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 20210816; Test Name: Alanine aminotransferase; Result Unstructured Data: 21; Test Date: 20210816; Test Name: White blood cell count; Result Unstructured Data: 12.9; Test Date: 20210816; Test Name: Amylase increased; Result Unstructured Data: 404; Test Date: 20210816; Test Name: Blood albumin; Result Unstructured Data: 4.7; Test Date: 20210816; Test Name: Blood alkaline phosphatase; Result Unstructured Data: 86; Test Date: 20210816; Test Name: Blood chloride; Result Unstructured Data: 101; Test Date: 20210816; Test Name: Blood creatinine; Result Unstructured Data: 0.99; Test Date: 20210816; Test Name: Blood glucose; Result Unstructured Data: 130; Test Date: 20210816; Test Name: Blood potassium; Result Unstructured Data: 4.3; Test Date: 20210816; Test Name: Blood sodium; Result Unstructured Data: 139; Test Date: 20210816; Test Name: Blood urea; Result Unstructured Data: 14; Test Date: 20210816; Test Name: CT scan; Result Unstructured Data: abnormal; Comments: Cholelithiasis and sclerotic osseous lesions incidentally noted largest measuring approximately 2.1 cm in the left iliac wing which could be bone islands but are nonspecific and neoplasia cannot be fully excluded.; Test Date: 20210816; Test Name: Carbon dioxide; Result Unstructured Data: 24; Test Date: 20210816; Test Name: Computerised tomogram head; Result Unstructured Data: abnormal; Comments: no evidence for acute intracranial hemorrhage, midline shift or mass effect, however, the right maxillary sinus contained a large retention cyst measuring approximately 3.1 cm in greatest dimensions.; Test Date: 20210816; Test Name: Bilirubin direct; Result Unstructured Data: <0.2; Test Date: 20210816; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: 94; Test Date: 20210816; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: 81; Test Date: 20210816; Test Name: Hematocrit; Result Unstructured Data: 42; Test Date: 20210816; Test Name: Hemoglobin; Result Unstructured Data: 14.6; Test Date: 20210816; Test Name: Lipase; Result Unstructured Data: 19; Test Date: 20210816; Test Name: Platelet count; Result Unstructured Data: 271000; Test Date: 20210816; Test Name: Red blood cell count; Result Unstructured Data: 4.8; Test Date: 20210816; Test Name: Bilirubin total; Result Unstructured Data: 0.9; Test Date: 20210816; Test Name: Protein total; Result Unstructured Data: 7.6; Test Date: 20210816; Test Name: Diagnostic ultrasound; Result Unstructured Data: abnormal; Comments: Cholelithiasis, but no signs of acute cholecystitis; Test Date: 20210816; Test Name: Urine analysis; Result Unstructured Data: Ketones: 2+ UBLD: Trace; Test Date: 20210816; Test Name: Aspartate aminotransferase; Result Unstructured Data: 16

Allergies:

Symptom List: Rash, Urticaria

Symptoms: ABDOMINAL PAIN; Protocol: 21-0012: After Receipt of EUA Vaccines Manufacturer Receipt Date: 24-AUG-2021 A clinical investigator reported that a 61-year old male (subject number: 808600959, site number not reported) experienced abdominal pain. The event occurred 16 days after COVID-19 vaccine Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. At reporting, the subject was recovering from abdominal pain. The subject's weight was 103 kilograms, and height was not reported. The subject's past medical history included: cataract surgery, and cataract surgery, and concurrent conditions included: depression, obesity, vitamin d deficiency, suspected sleep apnea, sedentary lifestyle, and non-smoker, and other pre-existing medical conditions included: Patient had no history of abdominal surgery. Patient family history included hypertension and giant cell glioblastoma of the brain. Concomitant medications included fluoxetine for depression, curcuma longa rhizome, ergocalciferol, ibuprofen, ketorolac, minoxidil, and prednisolone. The subject received 2 doses of Moderna vaccine (dates were not provided). On 30-JUL-2021, the subject was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number was not reported 0.5ml, anatomical vaccine site was not reported. On an unknown date, the subject has lower back pain. On 15-AUG-2021, the subject developed dull ache periumbilical pain. On 16-AUG-2021, the subject presented to emergency department (ED) with abdominal pain and back pain. His lower back pain showed improvement. The abdominal pain was associated with nausea, bloating, lightheadedness, dizziness, and headache, as well as some sweating and chills during the night. He denied vomiting and bowel movement changes. Review of systems was negative for shortness of breath and chest pain. Vitals showed blood pressure 172/102, respiratory rate 18, temperature 36.4 degrees Celsius (97.5 degrees Fahrenheit), SpO2 99% and heart rate 107. Abdominal examination showed tenderness in peri-umbilical area, however, there was no guarding or rebound. Musculoskeletal examination of the lumbar back showed no swelling, edema, deformity, signs of trauma, lacerations, spasms, tenderness, or scoliosis, as well as normal range of motion, negative right straight leg raise test and negative left straight leg raise test. Complete blood count with differential showed white blood cells 12.9 (elevated), red blood cells (RBC) 4.8, hemoglobin 14.6, hematocrit 42 and platelets 271 (Normal Range (NR) and units were not provided). Basic metabolic panel results showed glucose 130, sodium 139, potassium 4.3, chloride 101, carbon dioxide 24, anion gap 14, urea nitrogen 14, creatinine 0.99, calcium 9.9 (NR and units were not provided), glomerular filtration rate 81 ml/min/1.73, glomerular filtration rate 94 ml/min/1.73 (NR not provided). Right upper quadrant (RUQ) panel results showed amylase 404, lipase 19, total protein 7.6, albumin 4.7, total bilirubin 0.9, direct bilirubin < 0.2, alkaline phosphatase 86, aspartate transaminase 16, alanine transaminase 21 (NR and units were not provided). Urinalysis showed 2+ ketones and trace blood, 0-2 RBC and negative for leukocyte esterase, nitrites, protein and glucose. Computed tomography (CT) head without contrast showed no evidence for acute intracranial hemorrhage, midline shift or mass effect, however, the right maxillary sinus contained a large retention cyst measuring approximately 3.1 cm in its greatest dimensions. CT abdomen and pelvis with contrast showed cholelithiasis and two sclerotic osseous lesions incidentally noted, largest measuring approximately 2.1 cm in the left iliac wing which could be bone islands but are nonspecific and neoplasia cannot be fully excluded. Ultrasound abdomen showed cholelithiasis, but no signs of acute cholecystitis. The subject was recovering from abdominal pain. Investigator's causality assessment: The event of abdominal pain was not related to the study vaccine. Company causality assessment: The event of abdominal pain was not related to the study vaccine.; Sender's Comments: V0-Abdominal pain. 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: MEDICAL HISTORY(obesity), UNDERLYING DISEASE(cholelithiasis)

Other Meds: MODERNA VACCINE; FLUOXETINE; ERGOCALCIFEROL; IBUPROFEN; KETOROLAC; MINOXIDIL; PREDNISOLONE; TURMERIC

Current Illness: Depression; Non-smoker; Obesity; Sedentary; Sleep apnea; Vitamin D deficiency

ID: 1751726
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: GUILLAIN- BARRE SYNDROME; This spontaneous report received from consumer via social media from another pharmaceutical company concerned multiple patients. The patients height and weight were not reported. No past medical history or concurrent conditions were reported. The patients all 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 for prophylactic vaccination. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced Guillain-Barre Syndrome. The reporter stated that "the total data of adverse events from Vaccine Adverse Event Reporting System, comprising of all age groups from 14-DEC-2020 to 13-AUG-2021, showed 522 case reports of Guillain-Barre Syndrome out of which 25 percent of cases were attributed to use of JANSEEN COVID-19 VACCINE". No further details were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre Syndrome was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210957248, 20210957269, 20210957261 and 20210957342.; Sender's Comments: V0- 20210944284- covid-19 vaccine ad26.cov2.s Guillain barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1751727
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: GOT VERY SICK FROM THE SHOT ALMOST DEATH; This spontaneous report received from a patient via a company representative concerned multiple patients. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got very sick from the shot almost death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got very sick from the shot almost death was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1751728
Sex: M
Age:
State: CA

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

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

Lab Data: Test Date: 202106; Test Name: Antibody test; Result Unstructured Data: Antibodies were at 2; Test Date: 202109; Test Name: Antibody test; Result Unstructured Data: Slightly below 1

Allergies:

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

Symptoms: This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was at high risk of diabetes. The patient received COVID-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced low antibodies against covid virus. Laboratory data included: Antibody test (NR: not provided) Antibodies were at 2. The action taken with covid-19 vaccine was not applicable. The outcome of low antibodies against covid virus was not reported. This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1751729
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose and start therapy date were not reported, with frequency 1 total used for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the consumer called to learn more about the Janssen COVID-19 vaccine and if it was a Gene therapy and being forced on people. Then, she started yelling and cursing that 3 people died from COVID-19 along with her grandmother. However, she was unsure whether these patients died after the vaccine or not and claimed that Johnson & Johnson was hunting her family and blood line. They were storing her ancestor Deoxyribonucleic acid (DNA) and forced people to get the vaccine. She also claimed that Johnson & Johnson was responsible for the death of her family members and friends from COVID-19 and then trying to cover up things. On an unspecified date, the patient experienced suspected clinical vaccination failure and patient died from covid-19. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a Product Quality Complaint. This case, from the same reporter is linked to 20210950686, 20210950479 and 20210950539.; Sender's Comments: V0- 20210950658-Covid-19 vaccine ad26.cov2.s -Covid 19. 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). 20210950658-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; Reported Cause(s) of Death: COVID-19

Other Meds:

Current Illness:

Date Died:

ID: 1751730
Sex: U
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: DEATH; THROMBOCYTOPENIA; This spontaneous report received from a health care professional via social media (media) concerned multiple patients of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The reporter stated that "he was aware of media reports and various other avenues of reporting for 6 deaths (cause of death unspecified) and other severe adverse events like thrombocytopenia following vaccination with Janssen covid-19 vaccine." The reporter stated he could not recall where or when they first heard of these media reports and had no additional information to provide. It was not reported if an autopsy was performed for the patients who died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombocytopenia was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210952656 - Covid-19 vaccine ad26.CoV-2.s- Death, Thrombocytopenia. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1751731
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: COULD NOT WALK; COULD NOT STAND UP; CAUGHT A FLU OR A COLD; BAD REACTION/REACTION TO VACCINATION; EXTREME PAIN IN SPINE/BURNING SENSATION IN SPINE; LUNG HURTS/ BURNING SENSATION IN LUNG; COULD NOT DO ANYTHING FOR HER SELF; MESSED UP; EXTREME PAIN IN HIP AND JOINTS/BURNING SENSATION IN HIP; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stronger reaction to common cold, and stronger reaction to other illness, and concurrent conditions included: nerve damage in hips, chronic nerve pain, chronic illness, food intolerances, disabled, castor oil allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage, never had a reaction or anything like this in the past with a vaccine. He was very very comfortable getting a vaccine. The patient experienced drug allergy when treated with amoxicillin for drug used for unknown indication. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced could not walk, could not stand up, caught a flu or a cold, bad reaction/reaction to vaccination, extreme pain in spine/burning sensation in spine, lung hurts/ burning sensation in lung, could not do anything for her self, messed up, and extreme pain in hip and joints/burning sensation in hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk, could not stand up, caught a flu or a cold, bad reaction/reaction to vaccination, extreme pain in spine/burning sensation in spine, lung hurts/ burning sensation in lung, could not do anything for her self, messed up, and extreme pain in hip and joints/burning sensation in hip. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Disability; Disease progression; Food intolerance; Nerve damage; Nerve pain; Non-smoker; Oil allergy

Date Died: 09/01/2021

ID: 1751732
Sex: M
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: DECEASED; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (DELTA VARIANT); This solicited report received from a consumer: concerned a 51 year old male of unknown race. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered in FEB-2021 or MAR-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 (delta variant), and was hospitalized (date unspecified). Patient was released from the hospital and then re-admitted to the hospital. On SEP-2021 Patient was deceased. It was unspecified if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection (delta variant) and suspected clinical vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and deceased was related, and between covid-19 vaccine ad26.cov2.s, and suspected clinical vaccination failure, and suspected covid-19 infection (delta variant) was not related. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210953828.; Sender's Comments: V0: 20210953961-covid-19 vaccine ad26.cov2.s-deceased. 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). 20210953961-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 20210953961-covid-19 vaccine ad26.cov2.s-suspected covid-19 infection (delta variant). This event(s) is considered not related. The event(s) shows an incompatible temporal relationship.; Reported Cause(s) of Death: DECEASED

Other Meds:

Current Illness:

ID: 1751733
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 20210925; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive; Test Date: 20210925; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: MIGRAINES; CHEST PAIN; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 48 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1808609 expiry: unknown) dose was not reported, frequency time 1 total was administered on 23-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient had confirmed covid-19 infection. She started experiencing symptoms which included heavy congestion of the nose and sinuses, loss of smell and taste. On 24-SEP-2021, the patient started experiencing diarrhea and nausea. On 25-SEP-2021, the patient underwent COVID-19 rapid test and COVID-19 PCR test which was found to be positive, stated as breakthrough infection (confirmed clinical vaccination failure). On 26-SEP-2021, the patient also experienced shortness of breath and chest pain. On 27-SEP-2021, the patient experienced migraines. The migraines had been treated with the over the counter medication Excedrin (acetylsalicylic acid/caffeine/paracetamol/salicylamide). On 27-SEP-2021 and 28-SEP-2021, the patient stated that the chest pain was pretty significant. The patient visited physician office for all the symptoms/adverse effects she was experiencing. The action taken with covid-19 vaccine was not applicable. The patient recovered from diarrhea, was recovering from heavy congestion of the nose and sinuses, shortness of breath, chest pain and migraines, had not recovered from nausea and loss of smell and taste 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: 90000195072.; Sender's Comments: V0:20210955502-COVID-19 VACCINE Confirmed 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:

ID: 1751734
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: FELT WORSE AND WORSE; DID NOT WANTED TO MOVE, EVERYTHING HURT; WHEN WANTED TO GO TO SLEEP, SUDDENLY STARTED SWEATING FOR NO REASON WITH CESSATION; FREEZING ENDLESSLY IN AN ATTIC APARTMENT AT 25 DEGREES; ARM STILL HURTS A BIT; WHEN TRIED TO SHOWER FELT LIKE THERE WAS 1000 TINY NEEDLES STICKING; SLIGHT HEADACHE; HOT FLASHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 was not reported, administered on 24-SEP-2021 08:00 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021, the patient experienced hot flashes. On SEP-2021, the patient experienced arm still hurts a bit. On SEP-2021, the patient experienced when tried to shower felt like there was 1000 tiny needles sticking. On SEP-2021, the patient experienced slight headache. On 24-SEP-2021, the patient experienced felt worse and worse. On 24-SEP-2021, the patient experienced did not wanted to move, everything hurt. On 24-SEP-2021, the patient experienced when wanted to go to sleep, suddenly started sweating for no reason with cessation. On 24-SEP-2021, the patient experienced freezing endlessly in an attic apartment at 25 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt worse and worse, did not wanted to move, everything hurt, when wanted to go to sleep, suddenly started sweating for no reason with cessation, and freezing endlessly in an attic apartment at 25 degrees on 27-SEP-2021, and when tried to shower felt like there was 1000 tiny needles sticking on SEP-2021, and had not recovered from slight headache, arm still hurts a bit, and hot flashes. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751735
Sex: M
Age:
State: RI

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 10/01/2021
Hospital: Y

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

Lab Data: Test Date: 20210923; Test Name: MRI; Result Unstructured Data: Result not reported

Allergies:

Symptom List: Unevaluable event

Symptoms: MULTIPLE (7 OR 8) SEIZURES; PROBLEMS/ISSUE SWALLOWING; NERVE ISSUE; DIZZY; TROUBLE SEEING/VISION PROBLEMS; TINGLING KNEE/TINGLING LEG; NUMBNESS IN RIGHT LEG; SWOLLEN KNEE; SWOLLEN LEG; This spontaneous report received from a patient concerned a 62 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, and marijuana drug abuse (every once in a while). The patient stated that he had no medical history and was very healthy. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total administered in left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in MAY-2021, few weeks after the vaccination, the patient had numbing in the right leg above his knee that has gone into his foot. The numbness was only in the right leg, in the surface of his leg in the nerves or veins and it swelled and got worse because he's a tennis player. On 23-SEP-2021, the patient experienced multiple (7 or 8) seizures on the tennis court while playing and taken to the emergency room (ER) and was admitted to the hospital. The patient said that, doctors could not pinpoint what was going on but there were suspicions, and they were sure that the numbing in his leg was caused by the vaccine. While admitted he received Magnetic resonance imaging (MRI) scan (NR: not provided) result not reported and they put something on his head to record activity for 24 hours and determine if there were any more seizures to came. On an unspecified date, the patient had experienced dizzy, tingling knee/tingling leg, trouble seeing (vision problems) and problem/issues swallowing where if he drinks something very cold, he would gag. He reported that numbness in his leg was nothing that he had experienced before. He was prescribed with Levetiracetam 1000 milligram (mg) twice daily upon discharge. The patient was hospitalized for 4 days and discharged on 26-SEP-2021. The patient had made appointment with his primary care physician for next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from problems/issue swallowing, and had not recovered from numbness in right leg, nerve issue, dizzy, swollen knee, swollen leg, tingling knee/tingling leg, trouble seeing/vision problems, and multiple (7 or 8) seizures. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210955573-COVID-19 VACCINE AD26.COV2.S- Multiple (7 or 8) seizures. 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: Abstains from alcohol; Marijuana abuse (The patient do smoke a little marijuana every once in a while.); Non-smoker

ID: 1751736
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous pregnancy report received from a patient via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection and route of admin were not reported) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the patient had vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery were not reported. On an unspecified date, the patient had miscarriage. Patient reported that she had seen many people who had the vaccine and had miscarriage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210955581-COVID-19 VACCINE AD26.COV2.S-miscarriage. 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) 20210955581-COVID-19 VACCINE AD26.COV2.S-vaccine 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:

Current Illness:

ID: 1751737
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: STILLBIRTH; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned multiple female (three mothers) patients with unspecified ethnic origin and race. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date was unknown) dose was not reported, therapy start date were not reported, 1 total dose administered 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. unspecified date, the patients experienced stillbirth, and vaccine exposure during pregnancy. Reporter stated that, the patients (three mothers) had stillbirths due to the vaccine (the pregnancy resulted in a stillbirth). The date of the patient's last menstrual period and expected delivery date were not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stillbirth and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210955784-COVID-19 VACCINE AD26.COV2.S- Still birth. 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. 20210955784-COVID-19 VACCINE AD26.COV2.S- Vaccine exposure during pregnancy. 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: 1751738
Sex: F
Age:
State:

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

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

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

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. 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, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient got sick with Covid (suspected clinical vaccination failure, and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210955985-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:

ID: 1751739
Sex: M
Age:
State: HI

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

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

Lab Data:

Allergies:

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

Symptoms: LITTLE DIZZY; LOW GRADE FEVER; IRRITABLE; SLEPT ALL AFTERNOON; HARD TIME EATING; STOMACH MESSED UP; LACK OF APPETITE CONSUMING FOOD DID HELP A BIT; STOMACH QUEASY; THREW UP TWICE REALLY BAD; SORE ARM FOR COUPLE OF DAYS; VERY LETHARGIC; DOES NOT FEEL HIMSELF; CAN NOT GO TO WORK; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 140 pounds, and height was 69 inches. The patient's past medical history included: anxiety, and concurrent conditions included: pmhx discoid lupus (dle), pre diabetic, early kidney stage, early stage copd, marijuana usage, alcohol user, and cigarettes smoker, and other pre-existing medical conditions included: The patient had experienced sulfamethoxazole screwed up really bad and made lupus get bad on his arms. The patient was previously treated with diazepam for anxiety; and experienced drug allergy when treated with sulfamethoxazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced very lethargic. On SEP-2021, the patient experienced does not feel himself. On SEP-2021, the patient experienced can not go to work. On SEP-2021, the patient experienced sore arm for couple of days. On 26-SEP-2021, the patient experienced slept all afternoon. On 26-SEP-2021, the patient experienced hard time eating. On 26-SEP-2021, the patient experienced stomach messed up. On 26-SEP-2021, the patient experienced lack of appetite consuming food did help a bit. On 26-SEP-2021, the patient experienced stomach queasy. On 26-SEP-2021, the patient experienced threw up twice really bad. On 27-SEP-2021, the patient experienced irritable. On 28-SEP-2021, the patient experienced little dizzy. On 28-SEP-2021, the patient experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for couple of days on SEP-2021, had not recovered from very lethargic, irritable, little dizzy, hard time eating, stomach queasy, lack of appetite consuming food did help a bit, and stomach messed up, and the outcome of threw up twice really bad, slept all afternoon, does not feel himself, can not go to work and low grade fever was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (very rarely (due to DLE)); Cigarette smoker (3-4 cigarettes/day); COPD; Discoid lupus erythematosis; Marijuana use (consumed marijuana from time to time.); Pre-diabetic; Renal disease

ID: 1751740
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Name: HIV test; Result Unstructured Data: Positive; Comments: PRIOR VACCINATION

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: LITTLE FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart condition, chronic obstructive pulmonary disease (copd), congestive heart failure (chf), and human immunodeficiency virus (hiv). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient experienced little fever. Laboratory data (dates unspecified) included: HIV test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on 25-MAR-2021. This report was non-serious.

Other Meds:

Current Illness: Chronic obstructive pulmonary disease; Congestive heart failure; Heart disorder; HIV infection

ID: 1751741
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 09/25/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: VIGOROUSLY SHOOK THE VACCINE VIAL BEFORE ADMINISTERING; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 132 pounds, and height was 68 inches. 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: 204B21A expiry: 11-DEC-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced vigorously shook the vaccine vial before administering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vigorously shook the vaccine vial before administering was not reported. This report was associated with product quality complaint 90000195049 This report was non-serious.

Other Meds:

Current Illness:

ID: 1751742
Sex: U
Age:
State: NY

Vax Date:
Onset Date: 09/25/2021
Rec V Date: 10/01/2021
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: EXPIRED LOT VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 043A21A, and batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced expired lot vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired lot vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751743
Sex: U
Age:
State: LA

Vax Date:
Onset Date: 09/28/2021
Rec V Date: 10/01/2021
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: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751744
Sex: M
Age:
State: TX

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

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

Lab Data: Test Name: Diagnostic ultrasound; Result Unstructured Data: Not reported

Allergies:

Symptom List: Injection site pain

Symptoms: STILL FEELS ABNORMAL AND DIFFERENT; SWELLING OF THE RIGHT SIDE OF TESTICULAR AREA; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 205 pounds, and height was 69 inches. The patient's concurrent conditions included: seasonal allergy, alcohol user, non smoker, back problems, blood pressure, and cholesterol, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the patient experienced slight headache. On 11-APR-2021, the patient experienced swelling of the right side of testicular area. On an unspecified date, the patient experienced still feels abnormal and different. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the right side of testicular area on MAY-2021, and slight headache on 11-APR-2021, and the outcome of still feels abnormal and different was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Rarely); Back disorder; Blood pressure (Cholesterol medication); Cholesterol (Medication); Non-smoker; Seasonal allergy

ID: 1751745
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: BLOOD CLOTTING DISORDER; This spontaneous report received from a consumer concerned multiple patients. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clotting disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clotting disorder was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944284, 20210957269, 20210957261 and 20210957342.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1751746
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: MYOCARDITIS; PERICARDITIS; This spontaneous report received from consumer via social media from another pharmaceutical company concerned multiple patients. The patients weight and height were not reported. No past medical history or concurrent conditions were reported. The patients all 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 for prophylactic vaccination. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced myocarditis and pericarditis. The reporter stated that "the total data of adverse events from Vaccine Adverse Event Reporting System, comprising of all age groups from 14-DEC-2020 to 13-AUG-2021, showed 3033 case reports of myocarditis and pericarditis after vaccination out of which 78 cases were attributed to use of JANSEEN COVID-19 VACCINE". No further details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and pericarditis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210944284, 20210957248, 20210957269 and 20210957342.; Sender's Comments: 20210957261 -COVID-19 VACCINE AD26.COV2.S-Myocarditis , Pericarditis . 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: 1751747
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: ANAPHYLAXIS; This spontaneous report received from consumer via social media from another pharmaceutical company concerned multiple patients. The patients height and weight were not reported. No past medical history or concurrent conditions were reported. The patients all 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 for prophylactic vaccination. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced anaphylaxis. The reporter stated that "the total data of adverse events from Vaccine Adverse Event Reporting System, comprising of all age groups people from 14-DEC-2020 to 13-AUG-2021, showed 26,905 case reports of anaphylaxis out of which 8 percent of cases were attributed to use of JANSEEN COVID-19 VACCINE". No further details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylaxis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210944284, 20210957248, 20210957261 and 20210957342.; Sender's Comments: 20210957269- covid-19 vaccine ad26.cov2.s Anaphylaxis. This event(s) is labeled per RA and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1751748
Sex: M
Age:
State: WI

Vax Date:
Onset Date: 09/28/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: ADMINISTERED A DOSE OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 57 year old male. The patient's weight was 85 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administered a dose of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered a dose of expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751749
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 09/29/2021
Rec V Date: 10/01/2021
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: IRRITABLE SENSATION IN BACK OF NECK; COLD FEELING IN CHEST AND BACK OF NECK; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: abstains from alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced irritable sensation in back of neck. On 29-SEP-2021, the patient experienced cold feeling in chest and back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold feeling in chest and back of neck, and irritable sensation in back of neck. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1751750
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: BELL'S PALSY; This spontaneous report received from consumer via social media from another pharmaceutical company concerned multiple patients. The patients height and weight were not reported. No past medical history or concurrent conditions were reported. The patients all 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 for prophylactic vaccination. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced bell's palsy. The reporter stated that "the total data of adverse events from Vaccine Adverse Event Reporting System, comprising of all age groups people from 14-DEC-2020 to 13-AUG-2021, showed 2607 case reports of bell's palsy after vaccination out of which 7 percent of cases were attributed to use of JANSEEN COVID-19 VACCINE". No further details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bell's palsy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210944284, 20210957248, 20210957269 and 20210957261. .; Sender's Comments: V0- 20210957342- covid-19 vaccine ad26.cov2.s -Bell's palsy. 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: 1751751
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID; This spontaneous report received from a patient who reported via a company representative via social media which concerned a patient of unspecified age, sex, 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 was not reported, frequency one total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021 (first part of September), the patient experienced breakthrough covid with Flu/cold like symptoms that lasted 3 to 4 weeks (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid on SEP-2021 and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000195171.; Sender's Comments: V0: 20210957362-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:

ID: 1751752
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: PNEUMONIA; INTESTINAL ISSUES; BRAIN FOG; NERVE PAIN; MUSCLE WEAKNESS; This spontaneous report received from a consumer via a company representative via social media concerned a female of an unspecified age, 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, and expiry: unknown) dose, frequency time was 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 had brain fog, muscle weakness, and breathing problems. She also developed pneumonia, intestinal issues, and nerve pain. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the brain fog, muscle weakness, pneumonia, intestinal issues, and nerve pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210957410-COVID-19 VACCINE AD26.COV2.S - Pneumonia. 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: 1751753
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/01/2021
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: EXPIRED VACCINE ADMINISTERED TO 11 PATIENTS; This spontaneous report received from a health care professional concerned multiple patients. 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: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered to 11 subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to 11 patients was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751754
Sex: U
Age:
State: IN

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: DOSES WERE ADMINISTERED AFTER EXPIRATION DATE; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: 21-SEP-2021) dose, 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 patients experienced doses were administered after expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of doses were administered after expiration date was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751755
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: PUT IN ICU; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. 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, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, after vaccination the patient was kept in intensive care unit (ICU) for an unspecified adverse event. The hospitalization date was unknown. It was also reported that the patient cried that she had to get the vaccine because she did not want to get the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of put in ICU was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210958237-COVID-19 VACCINE AD26.COV2.S ?Put in ICU. This event is considered unassessable. The event has a unknown/unclear 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: 1751756
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/29/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 29 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, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423, 20210958321, 20210958993, 20210958502, 20210958716, 20210958892 and 20210958366.

Other Meds:

Current Illness:

ID: 1751757
Sex: U
Age:
State: WA

Vax Date:
Onset Date: 09/25/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FACIAL SWELLING; LEG SWELLING; SEVERE VERTIGO; IRREGULAR HEART RHYTHM; CHEST PAIN; STOMACH PAIN; SEVERE ABDOMINAL PAIN; BLURRED VISION; COULDN'T STAND ON FEET; NUMBNESS IN LEFT SHOULDER/NUMBNESS BEHIND NECK/COULDN'T FEEL THE RIGHT HALF OF HEAD; SEVERE AND PERSISTENT HEADACHE; SHARP AND STEADY HEART PAIN; GENERAL NORMAL SIDE EFFECTS; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies to medication or food at the time of vaccination. The patient had taken no medication or supplements before, at the time or after vaccination. The patient had no other illnesses at the time of vaccination. The patient had no chronic or long-standing health condition at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-SEP-2021:13:35 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021 after receiving the vaccination, patient experienced general normal side effects for two days. On 27-SEP-2021 at 08:00 AM, the patient started to have severe reaction including facial swelling, leg swelling, severe vertigo, irregular heart rhythm problem with sharp and steady heart pain, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision, numbness in left shoulder, numbness behind neck and she couldn't feel the right half of her head, and also the patient couldn't stand on her feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general normal side effects on 27-SEP-2021, and the outcome of facial swelling, leg swelling, severe vertigo, irregular heart rhythm, sharp and steady heart pain, numbness in left shoulder/numbness behind neck/couldn't feel the right half of head, severe and persistent headache, chest pain, stomach pain, severe abdominal pain, blurred vision and couldn't stand on feet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210958258-covid-19 vaccine ad26.cov2.s - sharp and steady heart pain. 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: 1751758
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/01/2021
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: VOMITING/THROWING UP/CAN'T HOLD ANYTHING DOWN; CAN'T GET OUT OF BED; This spontaneous report received from a consumer concerned a 39 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 (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced can't get out of bed. On 27-SEP-2021, the patient experienced vomiting /throwing up/can't hold anything down. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vomiting/throwing up/can't hold anything down, and can't get out of bed. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751759
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 102 Fever; Test Name: COVID-19 virus test; Result Unstructured Data: NEGATIVE

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex and unknown race and ethnicity. 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 an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-Aug-2021, It was reported that the "Same exact experience patient experienced, had J&J in April, got Covid Aug 2 with a friend who isn't vaxxed. Patient had it much worse than him. The patient had Fever of 102 (units unspecified) for 9 days. The patient stated that the patient did not got regenron, as the patient tested negative at first". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint.; Sender's Comments: 20210958300- 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:

ID: 1751760
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 29 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423, 20210958249, 20210958405, 20210958993, 20210958405, 20210958366, 20210958502 and 20210958716.

Other Meds:

Current Illness:

ID: 1751761
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/31/2021
Rec V Date: 10/01/2021
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: RECURRENT COLD SORES (AROUND, TOP AND BOTTOM OF LIPS AND SIDE OF TONGUE); SPLITTING OF THE LIPS; BITING OF THE TONGUE; BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 165 pounds, and height was 64 inches. The patient's concurrent conditions included: neuropathic pain, social alcohol drinker, and non smoker, and other pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for neuropathic pain, cyanocobalamin for neuropathic pain, ergocalciferol for neuropathic pain, and pregabalin for neuropathic pain. On 31-AUG-2021, the patient experienced recurrent cold sores (around, top and bottom of lips and side of tongue). On 31-AUG-2021, the patient experienced splitting of the lips. On 31-AUG-2021, the patient experienced biting of the tongue. On 31-AUG-2021, the patient experienced body aches. On 31-AUG-2021, the patient experienced chills. On 31-AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 07-SEP-2021, and had not recovered from recurrent cold sores (around, top and bottom of lips and side of tongue), splitting of the lips, and biting of the tongue. This report was non-serious.

Other Meds: ASA; LYRICA; VITAMIN B 12 [CYANOCOBALAMIN]; VITAMIN D [ERGOCALCIFEROL]

Current Illness: Neuropathic pain (Patient using the pain medications as needed.); Non-smoker; Social alcohol drinker (Patient consumes alcohol socially.)

ID: 1751762
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/28/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 44 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: 206A21A, and expiry: 21/SEP/2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958806 and 20210958405.

Other Meds:

Current Illness:

ID: 1751763
Sex: U
Age:
State: OK

Vax Date:
Onset Date: 09/29/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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 was not reported, administered on 29-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am