VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1481078
Sex: M
Age:
State:

Vax Date:
Onset Date: 06/16/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 54 year old male. Initial information was processed with the additional information received on 07-JUL-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number: Unknown) 45 mg, frequency was not reported, strength was 45 mg per 0.5 ml from JUL-2020 for psoriasis. Product constituent parts included ultrasafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported); and ultrasafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). The batch number was not reported and has been requested. No concomitant medications were reported. In JUN-2021, the patient had lab work done and did not have any antibodies to COVID. On 16-JUN-2021, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ustekinumab was not changed. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000185149 and 90000185150.; Sender's Comments: V0: 20210713254 - Covid-19 Vaccine Ad26.Cov2.S- Confirmed immunological vaccine failure - This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20210713254 ?Stelara - Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Psoriasis

ID: 1481079
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned 4 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) 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. On an unspecified date, the 4 patients experienced suspected clinical vaccination failure and suspected covid-19 infection, and Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. 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: 20210713297-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1481080
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 06/19/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: BURNING HEADACHE; BLURRY VISION; DIZZINESS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced dizziness. On 20-JUN-2021, the subject experienced blurry vision. On 02-JUL-2021, the subject experienced burning headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning headache, blurry vision, and dizziness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481081
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: CLOT BLOOD; This spontaneous report received from a consumer via a (other manufacturer Pfizer) 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) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced clot blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clot blood was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210713681-COVID-19 VACCINE AD26.COV2.S-Clot blood . 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: 1481082
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 07/03/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CONFIRMED COVID-19 INFECTION; STREPTOCOCCUS BACTERIAL INFECTION; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcoholic, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have had any 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, and expiry: 07-AUG-2021) dose was not reported, administered on 25-JUN-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced streptococcus bacterial infection. Laboratory data included: Streptococcus identification test (NR: not provided) Positive. On 05-JUL-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: Culture nose (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of streptococcus bacterial infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness: Alcoholic (Beer twice a week.); Non-smoker

ID: 1481083
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: INFLAMMATION OF LEG / LITTLE INFLAMMATION IN BODY; This spontaneous report received from a patient 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) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced inflammation of leg / little inflammation in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation of leg / little inflammation in body was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481084
Sex: U
Age:
State: OK

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: CAN HARDLY USE ELBOWS; This spontaneous report received from a patient concerned a 42 year old of unspecified 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) dose was not reported, administered on APR-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 can hardly use elbows. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can hardly use elbows was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481085
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: PART OF THE VACCINE WENT OUT; This spontaneous report received from a patient 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: 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 part of the vaccine went out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of part of the vaccine went out was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481086
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 06/04/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: BLOOD CLOT IN ABDOMEN AND EXTREMITIES; ANEURYSM CLOTS IN THE ABDOMEN; LOSS OF MOBILITY; LOSS OF APPETITE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. . The patient's past medical history included stent placed on lower extremities few years ago, and concurrent conditions included former smoker, cardiac issues, non-alcoholic and racing heart, and COPD (Chronic obstructive pulmonary disease) and other pre-existing medical conditions included no known allergies and patient does not abuse drug or illicit drug usage On 03-May-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: Unknown) frequency 1 total, dose was not reported, administered on right deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban, and sildenafil. On 04-JUN-2021, the patient experienced blood clot in abdomen and extremities, aneurysm clots in the abdomen, loss of mobility, loss of appetite and headache. The patient though the pain was due to medicines she had for cardiac disorder. The pain worsened to the point she went to her gastro intestinal doctor, who did CT scan which showed aneurysm. Her Doctor called cardiologist who suggested referral to a vascular surgeon. The vascular surgeon discovered more blood clots in the abdomen. The CT scan with contrast and Doppler studies were performed. The patient was on blood thinners for 3-4 months. The medicines were started prior to vaccination. None of the doctors were aware that she has taken the Johnson vaccine. The patient stated that she had all the side effects. On 28-JUN-2021, Laboratory data included: Oxygen consumption (NR: not provided) increased. On 28-JUN-2021, Laboratory data included: CT scan (NR: not provided) CT scan with contrast showed clots in abdomen and extremities. On 30-Jun-2021, the patient experienced aneurysm clots in the abdomen. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Not reported, and Ultrasound Doppler (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in abdomen and extremities, headache, loss of appetite, and loss of mobility, and the outcome of aneurysm clots in the abdomen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210716346-covid-19 vaccine ad26.cov2.s-Thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

Other Meds: XARELTO; VIAGRA [SILDENAFIL]

Current Illness: Abstains from alcohol; Cardiac disorder NOS; COPD (diagnosed earlier this year in Jan); Ex-smoker; Heart racing

ID: 1481087
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 07/07/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: SHORTNESS OF BREATH-A LITTLE; CHEST PAIN; CHILLS; NAUSEA; FEVER; MUSCLE PAIN; This spontaneous report received from a patient concerned a 23 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: Unk) dose was not reported, administered on 06-JUL-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021, the subject experienced shortness of breath-a little. On 07-JUL-2021, the subject experienced chest pain. On 07-JUL-2021, the subject experienced chills. On 07-JUL-2021, the subject experienced nausea. On 07-JUL-2021, the subject experienced fever. On 07-JUL-2021, the subject experienced muscle pain. On 08-JUL-2021, Laboratory data included: Chest X-ray (NR: not provided) Not reported, and EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, fever, chills, muscle pain, shortness of breath-a little, and chest pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481088
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BODY ACHES; ALLERGIC REACTION; FEVER ON AND OFF; This spontaneous report received from a patient 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: Unk) 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 body aches, allergic reaction, and fever on and off. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction, and the outcome of body aches and fever on and off was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481089
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: LESS ACTIVE; MORE TIRED; STOMACH ACID; MOUTH IS GETTING VERY DRY; NOT ABLE TO EAT/DID NOT FEEL LIKE EATING; FEELING VERY WEIRD; NOT ABLE TO TASTE/NO TASTE OF MY MOUTH; FEVER; CHILLS FELT VERY COLD; LOSING WEIGHT; NOT FEELING GOOD; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 100 pounds, and height was 59 inches. The patient's concurrent conditions included high blood pressure, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and there was 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 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine for blood pressure, and losartan for blood pressure. On MAR-2021, the subject experienced losing weight. On MAR-2021, the subject experienced not feeling good. Laboratory data included: Coronavirus test (NR: not provided) Negative. On 08-MAR-2021, the subject experienced chills felt very cold. On 08-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 deg. On 09-MAR-2021, the subject experienced not able to eat/did not feel like eating. On 09-MAR-2021, the subject experienced feeling very weird. On 09-MAR-2021, the subject experienced not able to taste/no taste of my mouth. On 09-MAR-2021, the subject experienced stomach acid. On 09-MAR-2021, the subject experienced mouth is getting very dry. On 11-MAR-2021, Laboratory data included: CT scan (NR: not provided) Normal. On 23-MAR-2021, Laboratory data included: Endoscopy (NR: not provided) Normal. On APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Coronavirus test (NR: not provided) Negative. On 01-APR-2021, the subject experienced less active. On 01-APR-2021, the subject experienced more tired. Treatment medications (dates unspecified) included: famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not able to eat/did not feel like eating, and feeling very weird on 15-APR-2021, and chills felt very cold, and fever on 09-MAR-2021, had not recovered from not able to taste/no taste of my mouth, losing weight, stomach acid, mouth is getting very dry, less active, and more tired, and the outcome of not feeling good was not reported. This report was non-serious.

Other Meds: LOSARTAN; AMLODIPINE

Current Illness: Abstains from alcohol; Blood pressure high; Non-smoker

ID: 1481090
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 07/06/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: EXPERIENCING MORE ENERGY POST VACCINATION; 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 pneumonia, and laryngitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: 15-AUG-2021) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the subject experienced experiencing more energy post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of experiencing more energy post vaccination was not reported. This report was non-serious.

Other Meds:

Current Illness: Laryngitis; Pneumonia

ID: 1481091
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 07/07/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: INJECTION SITE SORE ARM; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the subject experienced injection site sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site sore arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481092
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: LATE PERIODS; HEAVY BLEEDING DURING PERIOD/LONGER PERIODS/LASTING 7-9 DAYS EVER SINCE THE VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patients normally periods would last for 5 days.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 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 late periods, and heavy bleeding during period/longer periods/lasting 7-9 days ever since the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from late periods, and heavy bleeding during period/longer periods/lasting 7-9 days ever since the vaccine. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481093
Sex: U
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: INCREASED HEART RATE; SORE ARM AT THE INJECTION SITE; HEADACHE; TIREDNESS; 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 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 increased heart rate, sore arm at the injection site, headache, and tiredness. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm at the injection site, headache, tiredness and increased heart rate was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481094
Sex: M
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: STOMACH ACHE; SWOLLEN LEG; CHEST PAIN; MIGRAINES / HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stomach ache, swollen leg, chest pain, and migraines / headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, and swollen leg, and the outcome of migraines / headaches and chest pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481096
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 07/07/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: LOST CONSCIOUSNESS; COLD TO THE TOUCH; SWEATY; This spontaneous report received from a consumer concerned a 25 year old male. The patient's weight was 68 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 07-JUL-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, few minutes after the vaccination, the patient lost consciousness and regained it a minute later. The patient was also cold to the touch and sweaty. The patient had visited the doctor/healthcare professional office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness, cold to the touch, and sweaty on 07-JUL-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210718535- covid-19 vaccine ad26.cov2.s-Lost consciousness. This event(s) is considered un-assessable. 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: 1481097
Sex: U
Age:
State: TN

Vax Date:
Onset Date: 07/02/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: ADMINISTERED TIME 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: 1821287 expiry: 15-SEP-2021) dose was not reported, administered on 02-JUL-2021 10:41 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced administered time expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered time expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481098
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 06/29/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FALLING MORE AND WALKS WITH A CANE DUE TO WEAKNESS; SORE MUSCLES; BODY ACHES; RUNNY NOSE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 200.2 pounds, and height was 65 inches. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. patient does not remember the name of the blood pressure medication. 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 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced runny nose. On 02-JUL-2021, the subject experienced body aches. On 02-JUL-2021, the subject experienced sore muscles. On 06-JUL-2021, the subject experienced falling more and walks with a cane due to weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, sore muscles, runny nose, and falling more and walks with a cane due to weakness. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1481099
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HAVE NOT GET PERIOD CYCLE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 have not get period cycle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of have not get period cycle was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481100
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 07/08/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: VOMITING; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, non alcoholic, non smoker, and diabetes, and other pre-existing medical conditions included patient has no known drug allergies. no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 07-JUL-2021 19:00 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced vomiting. On 08-JUL-2021, the subject experienced chills. On 08-JUL-2021, the subject experienced nausea. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, and nausea on 08-JUL-2021. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Arthritis; Diabetes; Non-smoker

ID: 1481101
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: EYES FELT SWOLLEN/ RANDOM FEELING OF EYES BEING FULL OR SWOLLEN, EVEN THOUGH THEY DID NOT APPEARED SWOLLEN; GLOSSY AND RED EYES AS THOUGH SHE HAD BEEN CRYING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced eyes felt swollen/ random feeling of eyes being full or swollen, even though they did not appeared swollen. On 24-MAR-2021, the subject experienced glossy and red eyes as though she had been crying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes felt swollen/ random feeling of eyes being full or swollen, even though they did not appeared swollen, and glossy and red eyes as though she had been crying. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481102
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: RECEIVED VACCINE TWICE (TWO DOSES); MORE TIRED THAN USUAL; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included no known drug allergies, reported no health conditions and no current medications. 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 25-JUN-2021, and 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 received vaccine twice (two doses), and more tired than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine twice (two doses) and more tired than usual was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use; Smoker

ID: 1481103
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 07/02/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: THINNING BLOOD; TACHYPNEA; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 166 pounds, and height was 72 inches. The patient's past medical history included diabetic right foot neuropathy, and concurrent conditions included hypertension, type 2 diabetes mellitus, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient has no known allergies. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included insulin detemir for diabetes mellitus, insulin lispro for diabetes mellitus 2, enalapril for hypertension, and hydrochlorothiazide for hypertension. On 02-JUL-2021, the subject experienced thinning blood. On 02-JUL-2021, the subject experienced tachypnea. On 02-JUL-2021, the subject experienced muscle pain. On 02-JUL-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, muscle pain, and thinning blood, and the outcome of tachypnea was not reported. This report was non-serious.

Other Meds: HYDROCHLOROTHIAZIDE; LEVEMIR; ENALAPRIL; HUMALOG

Current Illness: Abstains from alcohol; Hypertension; Non-smoker; Type II diabetes mellitus (since 30 years)

ID: 1481104
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SOME BODY ACHES; FEVER 100; 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. The patient's pre-existing medical conditions included the patient had no known allergies and unknown drug abuse or illicit drug usage. Patient never had covid-19. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some body aches, and fever 100. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever 100, and some body aches. This report was non-serious. This report was associated with product quality complaint: 90000185398

Other Meds:

Current Illness:

ID: 1481105
Sex: M
Age:
State: WV

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 07/17/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: INTENSE PAIN; DIFFICULTY THINKING STRAIGHT; INTERMITTENT, INVOLUNTARY MOVEMENT OF LEFT FINGERS; SPELLS OF STUTTERING; SLURRED SPEECH 2-3 TIMES A DAY; DIFFICULTY SEEING; MIGRAINE "WORST PAIN IN LIFE"; RINGING IN EARS; NON-CONTAGIOUS MENINGITIS / BRAIN SWELLING / UNABLE TO MOVE NECK TO THE LEFT / STIFF NECK RADIATED TO SHOULDERS AND LEFT ARM AT INJECTION SITE / STIFF NECK TO THE LEFT SIDE; LIME DISEASE / CHILLS / MUSCLE ACHE / MILD FLU LIKE SYMPTOMS; HEADACHE; TIRED/ FATIGUE; COULD NOT SLEEP ALL NIGHT; KNEE SWELLED UP; LEFT KNEE PAIN; SPINAL CORD SHIFTING FROM BASE OF SKULL TO TAILBONE- POPPING AND CRACKING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and penicillin allergy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknown) dose was not reported with frequency 1 total administered on 25-MAR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient did not have any side effects initially and he was fine after vaccination and suddenly he felt tired an hour after arriving home, also could not be to sleep all night, mild flu-like symptoms including chills, muscle aches, fatigue and a headache. He took ibuprofen 200 mg via oral route (frequency unknown) for headache or pain. On 26-MAR-2021, the patient experienced headache again. On 02-APR-2021, the patient experienced headache which continued to get worse, brain swelling, non-contagious meningitis, lime disease (Lyme disease), migraine "worst pain in his life", difficulty seeing, ringing in ears. Then, he took more ibuprofen (frequency unknown) as the migraine was unbearable for him and had mild relief. The patient went to the hospital and was admitted on 02-APR-2021. At hospital he received morphine (indication unknown). On the same day, the laboratory testing or data of patient included CT scan reported as brain swelling reduced in size and spinal tap reported as unknown chemical found, positive for lime disease and meningitis. Laboratory testing revealed the meningitis of patient was non-contagious. The patient started on blood thinners and antibiotics (drugs name unknown). The patient got followed-up with (Centers for Disease Control and Prevention) CDC disease specialist who said that it could not be clearly revealed whether it was related to the vaccine or not. On 05-APR-2021, the patient experienced difficulty thinking straight, intermittent, involuntary movement of left fingers, spells of stuttering, slurred speech. The patient hospitalized for 4 days and got discharged from hospital on 05-APR-2021 at 20:00. On the night of 06-APR-2021, it was reported that in the middle of the night the patient woke-up at 01:00 as his spinal cord was shifting from base of skull to the tailbone, it was popping and cracking, no pain, just moving. It was gone when he work-up that morning. On 08-APR-2021 at morning, the patient experienced stiff neck to the left side / stiff neck radiated to shoulders and left arm at injection site as unable to move neck to the left side and the stiff neck got progressively worse each day and by 09-APR-2021, the stiff neck was more severe and radiated to the shoulders and to the left arm where he received his vaccine, not the right side, unable to move neck to the left side. However, this lasted until 13-APR-2021. On 26-MAY-2021, the patient woke up with pain and swelling in the left knee. On an unspecified date, the patient experienced intense pain. Treatment medications (dates unspecified) included: ibuprofen several times, morphine, antibiotics and blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lime disease / chills / muscle ache / mild flu like symptoms, migraine "worst pain in life", difficulty seeing, and ringing in ears on 05-APR-2021, non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side, spinal cord shifting from base of skull to tailbone- popping and cracking on 07-APR-2021 and knee swelled up, and left knee pain on 30-JUN-2021, had not recovered from tired/ fatigue, headache, spells of stuttering, intermittent, involuntary movement of left fingers, difficulty thinking straight, and slurred speech 2-3 times a day, and the outcome of could not sleep all night and intense pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210718928-covid-19 vaccine ad26.cov2.s-spinal cord shifting from base of skull to tailbone- popping and cracking ; non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side; lime disease / chills / muscle ache / mild flu like symptoms; difficulty thinking straight; migraine "worst pain in life"; ringing in ears; intermittent, involuntary movement of left fingers; spells of stuttering; slurred speech 2-3 times a day; difficulty seeing; intense pain; could not sleep all night. 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). 20210718928-covid-19 vaccine ad26.cov2.s-headache; tired/ fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness: Blood pressure high; Penicillin allergy

ID: 1481106
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: ALMOST NO ARM SORENESS; LITTLE FLASH FEVER; 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 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 almost no arm soreness, and little flash fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the almost no arm soreness and little flash fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481107
Sex: F
Age:
State: WV

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: MILD FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 25-MAR-2021, the subject experienced mild flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild flu like symptoms on 29-MAR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481108
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: COVID ARM; This spontaneous report received from a patient 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, expiry :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 covid arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481109
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/08/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: FEVER, BEGAN EXPERIENCING AT 5:00 AND RESOLVED ON SAME EVENING; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced fever, began experiencing at 5:00 and resolved on same evening. On 08-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, began experiencing at 5:00 and resolved on same evening on 08-JUL-2021, and had not recovered from headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481110
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 04/13/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SWOLLEN LYMPH GLANDS TO THE LEFT ARMPIT; TENDER LYMPH GLANDS TO THE LEFT ARMPIT; BALANCE ISSUES; TROUBLE WALKING STRAIGHT LINE; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included prior vertigo from ear infection, cardiac arrest, and ear infection, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: TPH1802070, and expiry: 09-JUL-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced balance issues. On 13-APR-2021, the subject experienced trouble walking straight line. On 16-APR-2021, the subject experienced swollen lymph glands to the left armpit. On 16-APR-2021, the subject experienced tender lymph glands to the left armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from balance issues, and trouble walking straight line on 25-JUN-2021, and had not recovered from swollen lymph glands to the left armpit, and tender lymph glands to the left armpit. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481111
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 07/04/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VOMITING (5 TIMES IN TOTAL SINCE THE ONSET); PERSISTENT CONSTANT/LIGHT NAGGING NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 160 pounds, and height was 64 centimeters. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes. On 04-JUL-2021, the subject experienced vomiting (5 times in total since the onset). On 04-JUL-2021, the subject experienced persistent constant/light nagging nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent constant/light nagging nausea, and vomiting (5 times in total since the onset). This report was non-serious.

Other Meds: INSULIN

Current Illness: Diabetic

ID: 1481112
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: REALLY BAD REACTION; STILL HAVE CHRONIC PAIN FROM IT MONTHS LATER; 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, 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 really bad reaction, and still have chronic pain from it months later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still have chronic pain from it months later, and the outcome of really bad reaction was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481113
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 07/09/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: VOMITING (NOTHING CAME OUT); DIZZINESS; HAND SORENESS; WEAKNESS; FEVER OF 104; NAUSEA; HEADACHE (FELT SHE COULD SCREAM); This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting (nothing came out). On 09-JUL-2021, the subject experienced dizziness. On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced weakness. On 09-JUL-2021, the subject experienced fever of 104. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (felt she could scream). Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 104, nausea, vomiting (nothing came out), weakness, headache (felt she could scream), hand soreness and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210724637.

Other Meds:

Current Illness:

ID: 1481114
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 06/04/2021
Rec V Date: 07/17/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: CHRONIC KIDNEY STONES; FEVER; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and smoker, and the patient does not have any no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient did not have any no known previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1A expiry: not reported) dose was not reported,1 total, administered on 04-JUN-2021 15:00 to left arm as prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021,at 9 PM after 6 hours of vaccination ,patient was feeling sick, he got fever and steadily got worse over 3 days. Patient went back to the normal before fever broke .On 5-JUN-2021 afternoon, he experienced the abdominal pain and pain steadily got worse. Patient experienced the pain in lower abdomen ,groin and shooting down his legs. Pain got worse and spread a little further. On 11-JUN-2021,following week patient went to the doctor. Patient reported that he was going to the doctor 6 to 8 times. Patient went to the hospital to get the ultrasound (NR: not provided) on lower abdomen, groin and chest. Ultrasound test results were normal. Patient had done a CAT scan (computerised tomogram) (NR: not provided) and found the Chronic kidney stone. Patient had the chronic kidney stones and was hospitalized. Patient reported that he was not having kidney stones before the vaccination. Patient did not remember when he went to the hospital. Patient told that he was prescribed with steroid. Patient reported that he had done with first round and at the time of reporting he was on the fourth day of second round. Patient told that, steroid not helped to his symptoms. Patient was also prescribed with muscle relaxer and Percocet as per need. Patient took only 3 pills of Percocet since 3 weeks ago because patient not like to take medicine. On 09-JUL-2021 the patient received the call from hospital to request a MRI on him. Patient reported that he was healthy like a horse before and now he felt like he was ready to die. Patient stated that pain had not recovered . Number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from chronic kidney stones. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210722902-COVID-19 VACCINE AD26.COV2.S-Chronic kidney stones. 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: Abstains from alcohol; Smoker

ID: 1481115
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 07/09/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DIFFICULTY BREATHING; SWOLLEN ANKLES ON BOTH SIDES (MORE NOTICEABLY AFTER THE VACCINE); LEAKAGE/GOING TO THE BATHROOM CONSISTENTLY; HEADACHE; TIRED; HARDLY SLEPT; DEHYDRATED (THIRSTY/DRY MOUTH); DRY RIGHT DOWN IN THE THROAT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, kidney infection, headache, swollen ankles, difficulty breathing, and leakage, and concurrent conditions included neuropathy, diabetic, and high blood pressure, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient's all medications were held at the time of vaccination. The patient was previously treated with oxygen for difficulty in breathing; and experienced drug allergy when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with naproxen sodium, chlortalidone, carvedilol, lisinopril, losartan, morphine, prednisone, tiotropium bromide, and rashes when treated with cobalt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On MAY-2021, Laboratory data included: Allergy test (NR: not provided) Not reported. On 09-JUL-2021, the subject experienced dehydrated (thirsty/dry mouth). On 09-JUL-2021, the subject experienced dry right down in the throat. On 09-JUL-2021, the subject experienced hardly slept. On 10-JUL-2021, the subject experienced difficulty breathing. On 10-JUL-2021, the subject experienced swollen ankles on both sides (more noticeably after the vaccine). On 10-JUL-2021, the subject experienced leakage/going to the bathroom consistently. On 10-JUL-2021, the subject experienced headache. On 10-JUL-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dehydrated (thirsty/dry mouth), swollen ankles on both sides (more noticeably after the vaccine), leakage/going to the bathroom consistently, difficulty breathing, hardly slept, headache, tired, and dry right down in the throat. This report was non-serious.

Other Meds: TYLENOL

Current Illness: Blood pressure high; Diabetic; Neuropathy

ID: 1481116
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 07/10/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: TEMPERATURE RANGING BETWEEN 95-95.5; CHILLS; FATIGUE; A LITTLE BIT OF A HEADACHE; ARM SORENESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced arm soreness. On 10-JUL-2021, the subject experienced fatigue. On 10-JUL-2021, the subject experienced a little bit of a headache. On 11-JUL-2021, the subject experienced temperature ranging between 95-95.5. On 11-JUL-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) ranging between 95-95.5. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, chills, temperature ranging between 95-95.5, and a little bit of a headache, and the outcome of arm soreness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481117
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 07/10/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SWOLLEN LYMPH NODE; PAINFUL LYMPH NODE; This spontaneous report received from a parent concerned a 20 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: 205A21a, and expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced swollen lymph node. On 10-JUL-2021, the subject experienced painful lymph node. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lymph node, and painful lymph node. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481118
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: WEIRD VISION DISTORTION; 9 HOURS LATER I STARTED GETTING WEIRD ACHES AND PAINS. LOCATED AROUND JOINTS IN MY BODY LIKE ANKLES, FINGERS, HIPS, KNEES, ETC; A VERY LIGHT FEVER (MIGHT NOT HAVE HAD A FEVER AT ALL BUT IT FELT LIKE A FEVER); WOKE UP FEELING HUNG OVER; AN HOUR LATER I STARTED TO GET CHILLS; INJECTION SITE BURN/STING AFTER INJECTION; This spontaneous report received from a patient 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, 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 weird vision distortion, 9 hours later i started getting weird aches and pains. located around joints in my body like ankles, fingers, hips, knees, etc, a very light fever (might not have had a fever at all but it felt like a fever), woke up feeling hung over, an hour later i started to get chills, and injection site burn/sting after injection. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird vision distortion, a very light fever (might not have had a fever at all but it felt like a fever), woke up feeling hung over, an hour later i started to get chills, and injection site burn/sting after injection, and was recovering from 9 hours later i started getting weird aches and pains. located around joints in my body like ankles, fingers, hips, knees, etc. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481119
Sex: M
Age:
State: CT

Vax Date:
Onset Date: 05/26/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: FAINTNESS/FELT LIKE PASSED OUT; DIFFICULTY EATING; RED MARK/DOT ON VACCINATED ARM; JOINT SORENESS; MUSCLE SORENESS; NAUSEA/FELT TO VOMIT WHILE EATING; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced throat swelled up when treated with amoxicillin. 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 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced faintness/felt like passed out. On 26-MAY-2021, the subject experienced difficulty eating. On 26-MAY-2021, the subject experienced red mark/dot on vaccinated arm. On 26-MAY-2021, the subject experienced joint soreness. On 26-MAY-2021, the subject experienced muscle soreness. On 26-MAY-2021, the subject experienced nausea/felt to vomit while eating. On 26-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea/felt to vomit while eating, joint soreness, headache, faintness/felt like passed out, red mark/dot on vaccinated arm, difficulty eating, and muscle soreness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481120
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 07/09/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: PAIN IN RIBS WHILE BREATHING IN; SHORTNESS OF BREATH/HUFFING AND PUFFING; FEELS CONSTRICTING; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included metastatic breast cancer. 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 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUL-2021, the subject experienced pain in ribs while breathing in. On 09-JUL-2021, the subject experienced shortness of breath/huffing and puffing. On 09-JUL-2021, the subject experienced feels constricting. On 10-JUL-2021, treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Patient had a spot in ribs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath/huffing and puffing, pain in ribs while breathing in, and feels constricting. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness: Metastatic breast cancer (metastatic breast cancer that has gone to the bone.)

ID: 1481121
Sex: M
Age:
State: WA

Vax Date:
Onset Date: 07/07/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HANDS, ARMS AND FACE BECAME FUZZY; HANDS, ARMS AND FACE BECAME NUMB; LOST 2 POUNDS IN 4 HOURS; SEVERE SORENESS IN HIS LEFT ARM; SORENESS IN SHOULDERS AND DOWN BACK; NAUSEA; SEVERE STOMACH PAIN; SEVERE VOMITING; SORENESS ALL DAY; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no reaction to vaccines previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 07-JUL-2021 10:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021 around 23.00 after vaccination, the patient developed severe soreness on left arm, shoulders and down back; it was reported that the patient had soreness all the day. The patient had severe vomiting to which patient lost two pounds in four hours. On 08-JUL-2021, patient was taken to ER (emergency room) at 5:45 and he continued to have severe stomach pain (stomach was moving), nausea and vomiting. The patient's hands, arms and face became fuzzy and then numb. The patient was given multiple unspecified medications to ease symptoms, along with an unspecified IV (intravenous). The patient also had tests of blood, urine and a CAT (computerized tomography) scan and the results were not reported. The patient was treated with morphine and was discharged from ER (emergency room) around noon on 08-JUL-2021. The patient's stomach was still not all the way well at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach pain, and the outcome of severe vomiting, soreness all day, nausea, hands, arms and face became fuzzy, hands, arms and face became numb, severe soreness in his left arm, soreness in shoulders and down back and lost 2 pounds in 4 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210723452- covid-19 vaccine ad26.cov2.s- severe stomach pain, severe vomiting, soreness all day, hands, arms and face became fuzzy, hands, arms and face became numb, lost 2 pounds in 4 hours . 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). 20210723452- covid-19 vaccine ad26.cov2.s- nausea, severe soreness in his left arm, soreness in shoulders and down back. This event(s) is labeled per Agency and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1481122
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 07/06/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed with the additional information received on 12-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: not reported) dose was not reported,1 total, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the patient was tested positive for COVID-19 (suspected COVID-19 infection and suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000185610.; Sender's Comments: V0:20210723506-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.

Other Meds:

Current Illness:

ID: 1481123
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 07/10/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: VACCINE ADMINISTERED FROM A PUNCTURED VIAL KEPT AT REFRIGERATION TEMPERATURE FOR 7 HOURS AND 26 MINUTES; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient at the time of reporting was not pregnant. The patient experienced drug allergy when treated with chlorhexidine, clindamycin, doxycycline, oxazolam, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced vaccine administered from a punctured vial kept at refrigeration temperature for 7 hours and 26 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered from a punctured vial kept at refrigeration temperature for 7 hours and 26 minutes was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1481124
Sex: M
Age:
State: DC

Vax Date:
Onset Date: 07/05/2021
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 27 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient had no known allergies and no medical history. 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, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-JUL-2021, the patient experienced a low grade fever. On 07-JUL-2021, patient had loss of taste, smell and was coughing. On 10-JUL-2021, the patient underwent SARS COV-2 antigen test and results came as positive (suspected clinical vaccination failure, suspected covid-19 infection). It was reported that the patient's felt his symptoms would have probably worst without the vaccination. The patient had not seen his health case professional at the time of this report. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be not void (meet PQC) based on the PQC evaluation/investigation performed. This report was associated with product quality complaint: 90000185601.; Sender's Comments: V0: 20210723839-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: Suspected Vaccination failure.

Other Meds:

Current Illness:

ID: 1481125
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BLOOD CLOTS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex 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) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. 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 legs hurting/blood clots. Left leg at knee amputation was performed to treat blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210724058-COVID-19 VACCINE AD26.COV2- blood clots. 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: 1481126
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: PARALYZED FROM THE WAIST DOWN; LOSS OF FEELING IN HANDS; This spontaneous report received from a patient from social media 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 not reported, batch number: not reported) dose were not reported,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. On an unspecified date, the patient was paralyzed from the waist down with loss of feeling in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralyzed from the waist down with loss of feeling in hands. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210724242- Covid-19 vaccine ad26.cov2.s - Paralyzed from the waist down . 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: 1481127
Sex: M
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: RASH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 11-MAY-2021 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 rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash. This report was non-serious. This case, from the same reporter is linked to 20210724371.

Other Meds:

Current Illness:

ID: 1481128
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BODY ACHES; STOMACH ISSUES; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 body aches, stomach issues, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, fever and stomach issues was not reported. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am