chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neuropathy peripheral, Pain, Pain in extremity, Vision blurred
Clinical narrative: CALL OFF WORK; JOINT PAIN; NAUSEA; HEADACHE; FATIGUE/ TIREDNESS; ARM ACHE; NEUROPATHY; DIARRHEA; BODYACHE AND LITTLE SHARP PAINS EVERYWHERE; SWOLLEN LYMPH NODES; BLURRY VISION; LETHARGIC; STOMACH CRAMPS; SWEATS; VOMITING; STOMACH DISCOMFORT; This spontaneous report received from a patient concerned a 48 year old female of unspecified ethnic origin. The patient's weight was 195 pounds and height was 70 inches. The patient's past medical history included Covid-19 (DEC-2020) and concurrent conditions included Hashimoto's disease, thyroid disease, blood pressure, leukocytosis, celiac disease, anemia, and auto immune disease. She had loss of smell, loss of taste since last 6 months. Patient was non alcohol user and non smoker. She was on a gluten free diet. The patient experienced drug allergy when treated with Dilaudid and Neomycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 23-JUN-2021) dose was not reported, 1 total dose administered on 10-JUN-2021 at 15:15 to right arm for prophylactic vaccination. Concomitant medications included Synthroid (levothyroxine sodium), hydrochlorothiazide and Claritin D (Loratadine/pseudoephedrine sulfate). On 12-JUN-2021, the patient experienced neuropathy, diarrhea, body ache, little sharp pains everywhere, swollen lymph nodes, blurry vision, lethargy/ tiredness, stomach cramps, sweats, vomiting, arm ache, nausea and headache. On 13-JUN-2021, the patient experienced joint pain. On JUN-2021, the patient experienced stomach discomfort and fatigue. On 14-JUN-2021 patient reported that she had to call off work and she did not have fever. She had not seen her doctor yet but would call the doctor. Treatment medications (dates unspecified) included: Aspirin (acetylsalicylic acid), Tylenol (paracetamol) and Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neuropathy on JUN-2021, was recovering from nausea, and vomiting, had not recovered from diarrhea, bodyache and little sharp pains everywhere, arm ache, headache, swollen lymph nodes, blurry vision, lethargic, stomach cramps, sweats, joint pain, stomach discomfort, and fatigue/ tiredness, and the outcome of call off work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210629819-  JANSSEN COVID-19 VACCINE Ad26.COV2.S- Neuropathy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: CALL OFF WORK; JOINT PAIN; NAUSEA; HEADACHE; FATIGUE/ TIREDNESS; ARM ACHE; NEUROPATHY; DIARRHEA; BODYACHE AND LITTLE SHARP PAINS EVERYWHERE; SWOLLEN LYMPH NODES; BLURRY VISION; LETHARGIC; STOMACH CRAMPS; SWEATS; VOMITING; STOMACH DISCOMFORT; This spontaneous report received from a patient concerned a 48 year old female of unspecified ethnic origin. The patient's weight was 195 pounds and height was 70 inches. The patient's past medical history included Covid-19 (DEC-2020) and concurrent conditions included Hashimoto's disease, thyroid disease, blood pressure, leukocytosis, celiac disease, anemia, and auto immune disease. She had loss of smell, loss of taste since last 6 months. Patient was non alcohol user and non smoker. She was on a gluten free diet. The patient experienced drug allergy when treated with Dilaudid and Neomycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 23-JUN-2021) dose was not reported, 1 total dose administered on 10-JUN-2021 at 15:15 to right arm for prophylactic vaccination. Concomitant medications included Synthroid (levothyroxine sodium), hydrochlorothiazide and Claritin D (Loratadine/pseudoephedrine sulfate). On 12-JUN-2021, the patient experienced neuropathy, diarrhea, body ache, little sharp pains everywhere, swollen lymph nodes, blurry vision, lethargy/ tiredness, stomach cramps, sweats, vomiting, arm ache, nausea and headache. On 13-JUN-2021, the patient experienced joint pain. On JUN-2021, the patient experienced stomach discomfort and fatigue. On 14-JUN-2021 patient reported that she had to call off work and she did not have fever. She had not seen her doctor yet but would call the doctor. Treatment medications (dates unspecified) included: Aspirin (acetylsalicylic acid), Tylenol (paracetamol) and Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neuropathy on JUN-2021, was recovering from nausea, and vomiting, had not recovered from diarrhea, bodyache and little sharp pains everywhere, arm ache, headache, swollen lymph nodes, blurry vision, lethargic, stomach cramps, sweats, joint pain, stomach discomfort, and fatigue/ tiredness, and the outcome of call off work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210629819-  JANSSEN COVID-19 VACCINE Ad26.COV2.S- Neuropathy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHY; FEVER; 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 (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-JUN-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 13-JUN-2021, the subject experienced achy. On 13-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever and achy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210629335.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a patient via a company representative concerned a 25 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included super healthy. 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 15-JUN-2021, the subject experienced sick. The action taken with covid-19 vaccine  was not applicable. The outcome of sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Rosacea
Clinical narrative: SWOLLEN LIPS; ROSACEA; RASH COVERING ENTIRE BODY INCLUDING PALMS OF HANDS; 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. The patient's concurrent conditions included cancer survivor, and other pre-existing medical conditions included on 19-APR-2021, patient received steroid injection. The patient experienced drug allergy when treated with vancomycin. The patient received covid-19 vaccine (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 swollen lips, rosacea, and rash covering entire body including palms of hands. The action taken with covid-19 vaccine was not applicable. The patient was recovering from rosacea, had not recovered from swollen lips, and the outcome of rash covering entire body including palms of hands was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED DOSE OF THE VACCINE FROM A VIAL THAT HAD BEEN PUNCTURED  26 HOURS PRIOR; PRODUCT STORAGE ERROR; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JUN-2021, the subject experienced administered dose of the vaccine from a vial that had been punctured 26 hours prior. On 09-JUN-2021, the subject experienced product storage error. The action taken with covid-19 vaccine was not applicable. The outcome of the administered dose of the vaccine from a vial that had been punctured 26 hours prior and product storage error was not reported. This report was non-serious. This report was associated with product quality complaint: 90000182689. The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be it was reported that the consumer was vaccinated with an expired vial that was first punctured 26 hours earlier.product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the pqc evaluation/investigation performed. based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: VERY FAINT BRUISE AT THE INJECTION SITE; This spontaneous report received from a patient 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 (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 very faint bruise at the injection site. The action taken with covid-19 vaccine was not applicable. The outcome of very faint bruise at the injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: BODY PAIN; CHILLS; FEVER; NAUSEA; EXTREME FATIGUE; HEADACHE; 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 (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 pain, chills, fever, nausea, extreme fatigue, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from body pain, chills, fever, nausea, extreme fatigue, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY PAIN; CHILLS; FEVER; NAUSEA; EXTREME FATIGUE; HEADACHE; 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 (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 pain, chills, fever, nausea, extreme fatigue, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from body pain, chills, fever, nausea, extreme fatigue, and headache. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pain assessment, Sinusitis
Clinical narrative: SINUSITIS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of allergies or sinuses infections.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced sinusitis. On 03-APR-2021, Laboratory data included: Pain scale (NR: not provided) 12 to 9. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) indicated sinusitis. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from sinusitis. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer (wife) concerned a 59 year old unspecified race and ethnic origin 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, and batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 01-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 patient experienced suspected immunological vaccine failure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000183050.; Sender's Comments: V0:20210632841-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine 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
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: SUDDEN CARDIAC DEATH CAUSED BY MYOCARDITIS; This spontaneous report received via social media from a patient via a company representative concerned a 30 year old male. The patient's weight, height and medical history were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: not reported) 1 total dose administered, 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, after eight days of vaccination, the patient died of sudden cardiac death caused by myocarditis. The reporter figured all this in the news and thought it could be related. The cause of death was myocarditis. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210632922-covid-19 vaccine ad26.cov2.s-sudden cardiac death caused by myocarditis. 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: MYOCARDITIS
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Fatigue, Myalgia, Pyrexia
Clinical narrative: CHEST PAIN; COUGH; FATIGUE; MUSCLE ACHES; FEVER; 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 (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced fatigue. On 14-JUN-2021, the subject experienced muscle aches. On 14-JUN-2021, the subject experienced fever. On 15-JUN-2021, the subject experienced chest pain. On 15-JUN-2021, the subject experienced cough. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chest pain, cough, fatigue, and muscle aches, and the outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: GIVEN VACCINES OUTSIDE OF TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced given vaccines outside of temperature excursion. On 01-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of the given vaccines outside of temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210633241.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ALREADY REFRIGERATED IN SOLUTION FORM THEN IT GOT RE-FROZEN; VACCINE GOT RE-FROZEN AND UPON THAWING IT WAS ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUN-2021, the subject experienced already refrigerated in solution form then it got re-frozen. On 09-JUN-2021, the subject experienced vaccine got re-frozen and upon thawing it was administered. The action taken with covid-19 vaccine was not applicable. The outcome of the already refrigerated in solution form then it got re-frozen and vaccine got re-frozen and upon thawing it was administered was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Feeling cold, Hypokinesia, Pain in extremity
Clinical narrative: FREEZING COLD; HEAD WAS COLD LIKE ICE/SEEMED LIKE DYING; WHOLE BODY COULD NOT MOVE; SHAKING; SORE ARM; NO ENERGY; This spontaneous report received from a patient concerned a 41 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 (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced no energy. On 18-APR-2021, the subject experienced freezing cold. On 18-APR-2021, the subject experienced head was cold like ice/seemed like dying. On 18-APR-2021, the subject experienced whole body could not move. On 18-APR-2021, the subject experienced shaking. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from freezing cold, head was cold like ice/seemed like dying, whole body could not move, and shaking, and the outcome of sore arm and no energy was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: FREEZING COLD; HEAD WAS COLD LIKE ICE/SEEMED LIKE DYING; WHOLE BODY COULD NOT MOVE; SHAKING; SORE ARM; NO ENERGY; This spontaneous report received from a patient concerned a 41 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 (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced no energy. On 18-APR-2021, the subject experienced freezing cold. On 18-APR-2021, the subject experienced head was cold like ice/seemed like dying. On 18-APR-2021, the subject experienced whole body could not move. On 18-APR-2021, the subject experienced shaking. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from freezing cold, head was cold like ice/seemed like dying, whole body could not move, and shaking, and the outcome of sore arm and no energy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema nodosum, Vaginal haemorrhage
Clinical narrative: ERYTHEMA NODOSUM; VAGINAL BLEEDING; 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 patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 0418218 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-APR-2021, the subject experienced vaginal bleeding. On 29-APR-2021, the subject experienced erythema nodosum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaginal bleeding on 10-JUN-2021, and had not recovered from erythema nodosum. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Hyperhidrosis, Insomnia
Clinical narrative: SWEATS; INCREASED IRREGULAR HEART BEAT; COULDNOT SLEEP/TROUBLE SLEEPING; 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 atrial fibrillation, and other pre-existing medical conditions included patient no known drug allergies. 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 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced sweats. On 15-JUN-2021, the subject experienced increased irregular heart beat. On 15-JUN-2021, the subject experienced couldnot sleep/trouble sleeping. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats, and couldnot sleep/trouble sleeping on 16-JUN-2021, and increased irregular heart beat on 15-JUN-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media 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, 1 total, administered on 02-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 an unspecified date in MAY-2021, she died from unknown cause of death. It was reported that, patient's obituary news was on paper on 17-MAY-2021. It was unspecified that if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20210634485- Covid-19 vaccine ad26.cov2.s-Death.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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 experienced fever when treated with influenza vaccine. 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 fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Swelling
Clinical narrative: REDNESS AROUND CAT SCRATCH; SWELLING  AREA  AROUND CAT SCRATCH; TIRED; This spontaneous report received from a health care professional concerned an 8 decade old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included cat scratch.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 16-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-JUN-2021, the subject experienced redness around cat scratch. On 16-JUN-2021, the subject experienced swelling area around cat scratch. On 16-JUN-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, redness around cat scratch and swelling area around cat scratch was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: MAY INJECTED MORE THAN 0.5ML; This spontaneous report received from a health care professional 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced may injected more than 0.5ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of may injected more than 0.5ml was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Headache, Nasopharyngitis
Clinical narrative: BODY ACHE; COLD; SLIGHT WEAKNESS; HEADACHE; TEMPERATURE SOMETIMES RAISED UP TO 38.5 C AND DROPS DOWN; This spontaneous report received from a consumer concerned a 37 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 19:00 for prophylactic vaccination. No concomitant medications were reported.  On 16-JUN-2021, the subject experienced body ache. On 16-JUN-2021, the subject experienced cold. On 16-JUN-2021, the subject experienced slight weakness. On 16-JUN-2021, the subject experienced headache. On 16-JUN-2021, the subject experienced temperature sometimes raised up to 38.5 c and drops down. Laboratory data included: Body temperature (NR: not provided) 38.5 C. On 17-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 36.6 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature sometimes raised up to 38.5 c and drops down on 17-JUN-2021, and had not recovered from slight weakness, headache, body ache, and cold. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHE; COLD; SLIGHT WEAKNESS; HEADACHE; TEMPERATURE SOMETIMES RAISED UP TO 38.5 C AND DROPS DOWN; This spontaneous report received from a consumer concerned a 37 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 19:00 for prophylactic vaccination. No concomitant medications were reported.  On 16-JUN-2021, the subject experienced body ache. On 16-JUN-2021, the subject experienced cold. On 16-JUN-2021, the subject experienced slight weakness. On 16-JUN-2021, the subject experienced headache. On 16-JUN-2021, the subject experienced temperature sometimes raised up to 38.5 c and drops down. Laboratory data included: Body temperature (NR: not provided) 38.5 C. On 17-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 36.6 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature sometimes raised up to 38.5 c and drops down on 17-JUN-2021, and had not recovered from slight weakness, headache, body ache, and cold. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Limb discomfort, Malaise, Pain
Clinical narrative: GENERAL SORENESS; ARM HEAVY; FEELS WEAKER; BODY CHILLS; GENERAL MALAISE; 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. 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 general soreness, arm heavy, feels weaker, body chills, and general malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm heavy, feels weaker, body chills, general soreness and general malaise was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist 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, intramuscular, batch number was not reported) dose was not reported, administered on 15-JUN-2021 14:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced temperature excursion. On 15-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210632861.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hyperhidrosis, Nausea, Pallor
Clinical narrative: PALE; SWEATS; FEVER; POUNDING HEADACHE; SICK STOMACH; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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 15-JUN-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 16-JUN-2021, the subject experienced pale. On 16-JUN-2021, the subject experienced sweats. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced pounding headache. On 16-JUN-2021, the subject experienced sick stomach. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pale, fever, sweats, pounding headache and sick stomach was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PALE; SWEATS; FEVER; POUNDING HEADACHE; SICK STOMACH; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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 15-JUN-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 16-JUN-2021, the subject experienced pale. On 16-JUN-2021, the subject experienced sweats. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced pounding headache. On 16-JUN-2021, the subject experienced sick stomach. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pale, fever, sweats, pounding headache and sick stomach was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: CHILLS; FEVER; PRETTY TIRED; 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: 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 chills, fever, and pretty tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and pretty tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: SHORTNESS OF BREATH; HEADACHES; This spontaneous report received from a patient via a company representative concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included birth control. 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 shortness of breath, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath and headaches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This spontaneous report received from a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 1 total, 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 17-JUN-2021, the the died from unknown cause of death. The father suspected that the death might be related to the Janssen Covid-19 vaccine. An autopsy was planned to be performed.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210637036- covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Photopsia, Vision blurred
Clinical narrative: BLURRED VISION; FLASHY THINGS AROUND EYES; NUMBNESS ON RIGHT SIDE; TINGLING ON RIGHT SIDE; PAIN ON LEFT SIDE DOWN TO THE BASE OF SKULL/SEVERE HEADACHE (HEADACHE UNBEARABLE); This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included contracted covid, and concurrent conditions included benign hypertension. The patient experienced drug allergy when treated with metformin, and amlodipine besilate for drug used for unknown indication. 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 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced blurred vision. On 27-MAY-2021, the subject experienced flashy things around eyes. On 27-MAY-2021, the subject experienced numbness on right side. On 27-MAY-2021, the subject experienced tingling on right side. On 27-MAY-2021, the subject experienced pain on left side down to the base of skull/severe headache (headache unbearable). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, flashy things around eyes, pain on left side down to the base of skull/severe headache (headache unbearable), numbness on right side, and tingling on right side. 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hot flush, Pyrexia
Clinical narrative: HOT FLASHES; CHILLS; HIGH GRADE FEVER/LOW GRADE FEVER; POUNDING HEADACHE; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: 09-JUL-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced hot flashes. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced high grade fever/low grade fever. On 05-MAR-2021, the subject experienced pounding headache. On 05-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 102.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, chills, and pounding headache on 06-MAR-2021, and high grade fever/low grade fever on 07-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HIGH FEVER; This spontaneous report received from a parent 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Inflammation, Skin warm
Clinical narrative: HEAVINESS IN CHEST AREA; HOT TO THE TOUCH; LEFT EAR INFLAMMATION; 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 patient was currently 3 months post-partum.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 16-JUN-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 16-JUN-2021, the subject experienced left ear inflammation. On 16-JUN-2021, the subject experienced hot to the touch. On 17-JUN-2021, the subject experienced heaviness in chest area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left ear inflammation, heaviness in chest area, and hot to the touch. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: SHORTNESS OF BREATH (FEELING CONSTRICTED BUT NOT COMPLETE LOSS OF BREATH); LEFT NECK LYMPH NODE SWELLING (NOW DECREASED IN SIZE, STILL PALPABLE AND INFLAMED); FEELS HYPOSTATIC; LIGHT HEADED; FEELING BACKED UP; CLOUDINESS IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included fever, tinnitus, and drug induced hypertension, and concurrent conditions included autoimmune disease -psoriatic arthritis, and other pre-existing medical conditions included the patient had experienced many adverse experiences with other vaccines/medications in the past. the patient had received steroids that resulted in bright pink torso and was aware about the steroid allergy. the patient thinks he had covid-19 back in december because he loss his sense of smell for 2 to 3 weeks. patient received a vaccine 10 years ago that gave him a fever for 10 days straight. The patient experienced hypertensive when treated with salbutamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, and expiry: 05/AUG/2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced cloudiness in urine. On 21-MAY-2021, the subject experienced shortness of breath (feeling constricted but not complete loss of breath). On 21-MAY-2021, the subject experienced left neck lymph node swelling (now decreased in size, still palpable and inflamed). On 21-MAY-2021, the subject experienced feels hypostatic. On 21-MAY-2021, the subject experienced light headed. On 21-MAY-2021, the subject experienced feeling backed up. On 01-JUN-2021, Laboratory data included: Blood test (NR: not provided) all clear. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 111/63. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (feeling constricted but not complete loss of breath), left neck lymph node swelling (now decreased in size, still palpable and inflamed), feels hypostatic, light headed, cloudiness in urine, and feeling backed up. This report was non-serious.