VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1312773
Sex: M
Age:
State: AL

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: PRODUCT STORAGE ERROR; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A expiry: 23/JUNE/2021) .5 ml, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced product storage error. On 06-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and poor quality vaccine administered was not reported. This report was non-serious. The Product Quality Complaint Number:90000178730 The suspected product quality complaint has been confirmed to be voided(did not meet PQC criteria) based on the PQC evaluation/investigation performed.

Other Meds:

Current Illness:

ID: 1312774
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: VACCINE ADMINISTERED TO PATIENT PAST ITS TEMPERATURE EXCURSION; INCORRECT STORAGE OF DRUG; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAY-2021, the subject experienced vaccine administered to subject past its temperature excursion. On 06-MAY-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient past its temperature excursion and incorrect storage of drug was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312775
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: FELT BAD; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced felt bad. The action taken with covid-19 vaccine was not applicable. The outcome of felt bad was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312776
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/08/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: EYE PAIN; SEVERE HEADACHE; FEVER; FEELING THIRSTY; FELT MASSIVE PAIN RADIATING IN BODY AND PAIN IN LEGS AND ARMS; BLURRY VISION AND WHITE CLOUD OVER EYES; FELT LIKE LOSING SIGHT; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did have no known drug allergies and no known health conditions and not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt like losing sight. On 2021, the subject experienced blurry vision and white cloud over eyes. On 2021, the subject experienced felt massive pain radiating in body and pain in legs and arms. Laboratory data included: CAT scan (NR: not provided) couldn't diagnose, Electrocardiogram (NR: not provided) couldn't diagnose, Eye exam (NR: not provided) couldn't diagnose, Lab test (NR: not provided) didn't see any blockage and couldn't figure out, and MRI (NR: not provided) couldn't diagnose. On 08-MAR-2021, the subject experienced feeling thirsty. On 09-MAR-2021, the subject experienced eye pain. On 09-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: macrogol 400/propylene glycol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye pain, blurry vision and white cloud over eyes, and felt massive pain radiating in body and pain in legs and arms, and the outcome of feeling thirsty, severe headache, fever and felt like losing sight was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1312777
Sex: U
Age:
State: ID

Vax Date:
Onset Date: 05/03/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: VACCINE LEFT OUT OVER NIGHT ABOUT 12 HOURS BEFORE ADMINISTRATION; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 03-MAY-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 03-MAY-2021, the subject experienced left out over night about 12 hours. On 03-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and left out over night about 12 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210512313.

Other Meds:

Current Illness:

ID: 1312778
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: UPPER BODY SORENESS; SORE ARM; TIRED; HEADACHE; FEVER ON AND OFF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) 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 subject experienced upper body soreness, sore arm, tired, headache, and fever on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, upper body soreness, headache, sore arm and fever on and off was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312779
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BAD CHILLS; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bad chills, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and bad chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312780
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DIARRHEA; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 28 year old male. 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) 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 subject experienced diarrhea, and flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and flu-like symptoms. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312781
Sex: M
Age:
State: MN

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SEVERE PAIN ON LEFT LEG; SEVERE FATIGUE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use, and non smoker, and other pre-existing medical conditions included no known allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for high blood pressure. On 10-APR-2021, the subject experienced flu like symptoms. On 10-APR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 14-APR-2021, the subject experienced severe pain on left leg. Laboratory data included: Diagnostic ultrasound (NR: not provided) negative, and Echocardiogram (NR: not provided) negative. Treatment medications (dates unspecified) included: menthol/methyl salicylate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain on left leg, severe fatigue, and flu like symptoms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

Other Meds: LOSARTAN

Current Illness: Alcohol use (consumes alcohol occasionally); Blood pressure high; Non-smoker

ID: 1312782
Sex: F
Age:
State: NM

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 05/13/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BLOOD CLOT IN BRAIN; BODYACHES; HORRIBLE NAUSEA; SLIGHT FEVER; This spontaneous report received from social media/news via a company representative concerned a female of unspecified age. 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) dose was not reported, 1 total administered on 08-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 09-APR-2021, the patient developed blood clot in brain and it was discovered by computed tomography (CT) scan (date unspecified), went to emergency room (ER). He was admitted in the hospital (date unspecified) for blood clot in brain. On the same day, the patient also experienced body aches, horrible nausea and horrible headache, slight fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in brain, horrible nausea, body aches and slight fever was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210514154-covid-19 vaccine ad26.cov2.s-blood clot in brain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1312783
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: TONGUE PROBLEMS-BURNS; LIGHT HEADED NOW AND THEN; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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) 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 subject experienced tongue problems- burns, and light headed now and then. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tongue problems-burns and light headed now and then was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312784
Sex: U
Age:
State: OH

Vax Date:
Onset Date: 05/08/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312785
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ARM IS STILL VERY SORE; CHILLS AND SHIVERS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 04-MAY-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 MAY-2021, the subject experienced arm is still very sore. On MAY-2021, the subject experienced chills and shivers. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills and shivers, fever, headache, and fatigue on MAY-2021, and had not recovered from arm is still very sore. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312786
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: TINGLING IN LIPS; LIPS GOT WARM; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included cold sores. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unexpected therapeutic benefit. On 08-APR-2021, the subject experienced tingling in lips. On 08-APR-2021, the subject experienced lips got warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in lips, and the outcome of lips got warm and unexpected therapeutic benefit was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312787
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BODY ACHES; CHILLS; LOW GRADE FEVER; POUNDING HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) 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 2021, Laboratory data included: Body temperature increased (NR: not provided) 100 F, 101.7 F, 103 F. On an unspecified date, the subject experienced body aches, chills, low grade fever, pounding headache, and nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, low grade fever, pounding headache, and nausea. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312788
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 05/08/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BLURRED VISION; HEADACHE; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, back pain, anxiety, non alcohol user, and non smoker. The patient experienced drug allergy when treated with morphine, and tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone hydrochloride/paracetamol for back pain. On 08-MAY-2021, the subject experienced blurred vision. On 08-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and had not recovered from headache. This report was non-serious.

Other Meds: PERCOCET

Current Illness: Abstains from alcohol; Anxiety; Back pain; Blood pressure high; High cholesterol; Non-smoker

ID: 1312789
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 05/08/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: LEGS SWELLING/ SWELLING IN CALF MUSCLE; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, atrial fibrillation (afib), non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced legs swelling/ swelling in calf muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from legs swelling/ swelling in calf muscle. This report was non-serious.

Other Meds:

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

ID: 1312790
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/08/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BLEEDING IN THE MOUTH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and light bleeding in mouth, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced bleeding in the mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding in the mouth. This report was non-serious.

Other Meds:

Current Illness: Bleeding mouth; Cigarette smoker (1 packet per week)

ID: 1312791
Sex: F
Age:
State: IA

Vax Date:
Onset Date: 05/07/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CONSTANT DIZZINESS; WEAKNESS TO THE POINT OF CONCERN; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's past medical history included cardiac arrest, and concurrent conditions included chronic obstructive pulmonary disease, diabetes, high blood pressure, and henoch-schonlein purpura. The patient had no known allergies. 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 04-MAY-2021 19:00:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced dizziness. On 07-MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and weak. This report was non-serious.

Other Meds:

Current Illness: Blood pressure high; Chronic obstructive pulmonary disease; Diabetes; Hard of hearing; Henoch-Schonlein purpura

ID: 1312792
Sex: U
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: PATIENT VACCINATED WITH EXPIRED PRODUCT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Unk) 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 subject experienced subject vaccinated with expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient vaccinated with expired product was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312793
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 05/09/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: THE VACCINATION SITE WAS WARM TO THE TOUCH; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, thyroid problems, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and not allergic to medication. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced the vaccination site was warm to the touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination site was warm to the touch was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Blood pressure high; High cholesterol; Non-smoker; Thyroid disorder

ID: 1312794
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SEVERE STOMACH ISSUES; DIARRHEA; STOMACH CRAMPS; GAS; This spontaneous report received from a patient concerned a female of unspecified age. 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) 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 subject experienced severe stomach issues, diarrhea, stomach cramps, and gas. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe stomach issues, diarrhea, stomach cramps and gas was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312795
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: FREEZING; SHIVERING; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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) 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 shivering, freezing, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering, freezing, and low grade fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312796
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: TINY BIT OF CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On MAR-2021, the subject experienced tiny bit of chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiny bit of chills. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312797
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CHILLS; FEVER; FATIGUE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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) 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 subject experienced chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210516321.

Other Meds:

Current Illness:

ID: 1312798
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CONFIRMED COVID-19 INFECTION (FLU SYMPTOMS); This spontaneous report received from a patient concerned a male of unspecified age. 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) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 06-MAY-2021, the subject experienced confirmed covid-19 infection (flu symptoms). Laboratory data included: COVID-19 PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection (flu symptoms) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312799
Sex: F
Age:
State: AK

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via media article/social media platform concerned a female of unspecified age. 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) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that, on an unspecified date, the patient caught covid-19 infection for the second time after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210517156-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: 1312800
Sex: M
Age:
State: MD

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: FLAT RED RASH AREAS ON BOTH ARMS AND ON THE BICEPS; HIVES; FEVER; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced flat red rash areas on both arms and on the biceps. On 09-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, and chills on MAR-2021, and fever, and had not recovered from hives, and flat red rash areas on both arms and on the biceps. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312801
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 05/05/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: NUMBNESS FROM TOP OF SHOULDER INTO CHEST ALONG THE COLLAR BONE ON SAME SIDE OF INJECTION; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gastrointestinal issues, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAY-2021, the subject experienced numbness from top of shoulder into chest along the collar bone on same side of injection. The action taken with covid-19 vaccine was not applicable. The patient was recovering from numbness from top of shoulder into chest along the collar bone on same side of injection. This report was non-serious.

Other Meds:

Current Illness: Gastrointestinal disorder (missing 1/3 intestine/ colon)

ID: 1312802
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: RED PIN LIKE DOTS UNDER SKIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced red pin like dots under skin. The action taken with covid-19 vaccine was not applicable. The outcome of red pin like dots under skin was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312803
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: MESS ME UP BIG TIME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced mess me up big time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mess me up big time was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312804
Sex: F
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ELEVATED D DIMER; ITCHY AND UNCOMFORTABLE RASH ( BOTH LEGS AND RIGHT FLANK); This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no other pertinent medical history shared. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number:1805018 and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced elevated d dimer, and itchy and uncomfortable rash (both legs and right flank). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets, white blood cells and red blood cells are normal, and Fibrin D dimer (NR: not provided) weakly positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchy and uncomfortable rash (both legs and right flank), and the outcome of elevated d dimer 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: 1312805
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 04/24/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: STROKE; This spontaneous report received from a consumer concerned a 75year old female. 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: 1476806 expiry: 21-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2021, the patient experienced stroke. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210517403-COVID-19 VACCINE AD26.COV2.S-Stroke. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: 1312806
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BODY ACHES; STOMACH WOES FLARED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced stomach woes flared. The action taken with covid-19 vaccine was not applicable. The outcome of the body aches and stomach woes flared was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312807
Sex: U
Age:
State: OH

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAY-2021 18:00:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312808
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SEVERE REACTION; BODYACHES; STRANGEST METALLIC TASTE; HEAD ACHES; HIGH FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose was not reported, 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 an unspecified date, the subject experienced severe reaction, body aches, strangest metallic taste, head aches, high fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe reaction, body aches, strangest metallic taste, head aches, high fever, and nausea. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312809
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: RAPID HEART RATE; GENERALIZED MUSCLE CRAMPING; PINS AND NEEDLES IN FEET THAT MOVED UPWARD; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced rapid heart rate. On APR-2021, the subject experienced generalized muscle cramping. On APR-2021, the subject experienced pins and needles in feet that moved upward. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle cramping, pins and needles in feet that moved upward, and rapid heart rate. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312810
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SLIGHT HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 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 an unspecified date, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312811
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SHOOTING PAIN; PAIN IN LEFT SHOULDER THAT STARTS FROM END OF THE NECK AND GOES ALL THE WAY DOWN TO LEFT ARM AND ELBOW AND COMES BACK AND HARDLY COULD RAISE ARM UP; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included pain, and other pre-existing medical conditions included the patient had experienced something similar to the adverse event in past but that did not last long. The patient was previously treated with ibuprofen for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206AZ1A expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced shooting pain. On MAY-2021, the subject experienced pain in left shoulder that starts from end of the neck and goes all the way down to left arm and elbow and comes back and hardly could raise arm up. On 09-MAY-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left shoulder that starts from end of the neck and goes all the way down to left arm and elbow and comes back and hardly could raise arm up, and shooting pain. This report was non-serious.

Other Meds:

Current Illness:

Date Died: 03/18/2021

ID: 1312812
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 03/17/2021
Rec V Date: 05/13/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BLEEDING IN BRAIN; INTUBATED; SEVERE HEADACHE; This spontaneous report received from a consumer via company representative concerned a 45 year old female with unknown 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: not reported) dose 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-MAR-2021, the patient experienced severe headache and went to the hospital and diagnosed with bleeding in brain. During hospitalization patient was intubated .On 18-Mar-2021,patient died due to bleeding in brain. Patient was hospitalized for 1 day. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intubated and severe headache was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210517658- covid-19 vaccine ad26.cov2.s-Bleeding in brain, intubated. 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: BLEEDING IN BRAIN

Other Meds:

Current Illness:

ID: 1312813
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: MILD ARM SORENESS THAT GOT SPIKED; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: 23/JUN/2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced mild arm soreness that got spiked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild arm soreness that got spiked on MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210518415.

Other Meds:

Current Illness:

ID: 1312814
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 05/10/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: VACCINE ADMINISTERED OUTSIDE OF EXPIRY SAFETY GUIDELINES; MEDICATION ERROR; VACCINE REMOVED FROM FRIDGE AT 09:40; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a 31 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history on file with pharmacy. no known drug allergies on file with pharmacy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, expiry: 10-MAY-2021) dose was not reported, administered on 10-MAY-2021 17:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced vaccine administered outside of expiry safety guidelines. On 10-MAY-2021, the subject experienced medication error. On 10-MAY-2021, the subject experienced vaccine removed from fridge at 09:40. On 10-MAY-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of expiry safety guidelines, medication error, vaccine removed from fridge at 09:40 and incorrect storage of drug was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312815
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 05/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: TREMENDOUS HEADACHE LIKE MIGRAINE; MILD PAIN IN THE INJECTION SITE; MILD ALLERGY; TIGHTNESS OF CHEST; FLU LIKE SYMPTOMS; THROAT FELT FUNNY; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to dust, and acid reflux. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced tightness of chest. On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced throat felt funny. On 08-APR-2021, the subject experienced mild pain in the injection site. On 08-APR-2021, the subject experienced mild allergy. Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 09-APR-2021 03:00, the subject experienced tremendous headache like migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness of chest, throat felt funny, tremendous headache like migraine, mild pain in the injection site, and mild allergy on APR-2021, and flu like symptoms on 2021. This report was non-serious.

Other Meds:

Current Illness: Gastrooesophageal reflux disease; House dust allergy

ID: 1312816
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
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Symptoms: VACCINE WAS ADMINISTERED TO A 16 YEARS OLD BY ACCIDENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine was administered to a 16 years old by accident, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine was administered to a 16 years old by accident was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312817
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/13/2021
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Symptoms: HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.

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Current Illness:

ID: 1312818
Sex: F
Age:
State: SC

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/13/2021
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Symptoms: BLOATING; CRAMPS; CHILLS; FEVER; HEADACHE; LOSS OF APPETITE; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non alcohol, and non smoker, and other pre-existing medical conditions included the patient has no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07/MAY/2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On MAY-2021, the subject experienced abdominal pain. On MAY-2021, the subject experienced loss of appetite. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced cramps. On 08-MAY-2021, the subject experienced bloating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache, and had not recovered from abdominal pain, cramps, loss of appetite, and bloating. This report was non-serious.

Other Meds: VITAMINS NOS

Current Illness: Abstains from alcohol; Non-smoker; Penicillin allergy

ID: 1312819
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/13/2021
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Symptoms: SEVERE MIGRAINE; LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included arterial venous malformation in brain.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: MVX1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced leg pain. On 14-MAR-2021, the subject experienced severe migraine. Laboratory data included: CT scan (NR: not provided) arterial venous malformation in brain, details of scan unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine, and leg pain. This report was non-serious.

Other Meds:

Current Illness: Cerebral arteriovenous malformation haemorrhagic

ID: 1312820
Sex: F
Age:
State: MD

Vax Date:
Onset Date: 05/09/2021
Rec V Date: 05/13/2021
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Symptoms: ALLERGIES; HEADACHE; GREEN VEIN UNDER ARM; SORE ARM; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced green vein under arm. On 09-MAY-2021, the subject experienced sore arm. Treatment medications included: paracetamol. On 09-MAY-2021 20:00, the subject experienced headache. On 10-MAY-2021, treatment medications included: cetirizine hydrochloride, and paracetamol. On an unspecified date, the subject experienced allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, headache, and green vein under arm, and the outcome of allergies was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312821
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 05/10/2021
Rec V Date: 05/13/2021
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Symptoms: VERTIGO; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. Concomitant medications were reported. On 10-MAY-2021, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1312822
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 05/13/2021
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Symptoms: BODY ACHES; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and did not have any history of drug abuse or illicit drug use. no medical history or diagnosis was reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced headaches. On 10-MAY-2021, Laboratory data included: Coronavirus test (NR: not provided) pending on results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, and body aches. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm