chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, COVID-19, Chills, Ear pain
Clinical narrative: SORE THROAT; COUGHING UP BROWN MUCUS INITIALLY WHICH IS NOW GREENISH WHITE; RIGHT SIDED EARACHE; FATIGUE; SICK TO STOMACH/NAUSEA; PAIN AT INJECTION SITE; EDEMA; CHILLS; TEMPERATURE ELEVATED; BAD HEADACHE; SWELLING UNDER THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 175 pounds, and height was 68 inches. The patient's past medical history included covid-19 infection, and concurrent conditions included high cholestrol, gerd, latex allergy, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient has no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gerd, and atorvastatin calcium for high cholestrol. On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On JUN-2021, the subject experienced swelling under the arm. On 04-JUN-2021, the subject experienced chills. On 04-JUN-2021, the subject experienced temperature elevated. On 04-JUN-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 05-JUN-2021, the subject experienced edema. On 05-JUN-2021, the subject experienced fatigue. On 05-JUN-2021, the subject experienced sick to stomach/nausea. On 05-JUN-2021, the subject experienced pain at injection site. On 06-JUN-2021, the subject experienced coughing up brown mucus initially which is now greenish white. On 06-JUN-2021, the subject experienced right sided earache. On 06-JUN-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick to stomach/nausea on 07-JUN-2021, was recovering from bad headache, chills, edema, right sided earache, and pain at injection site, had not recovered from temperature elevated, fatigue, coughing up brown mucus initially which is now greenish white, and sore throat, and the outcome of swelling under the arm was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Oedema
Clinical narrative: SORE THROAT; COUGHING UP BROWN MUCUS INITIALLY WHICH IS NOW GREENISH WHITE; RIGHT SIDED EARACHE; FATIGUE; SICK TO STOMACH/NAUSEA; PAIN AT INJECTION SITE; EDEMA; CHILLS; TEMPERATURE ELEVATED; BAD HEADACHE; SWELLING UNDER THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 175 pounds, and height was 68 inches. The patient's past medical history included covid-19 infection, and concurrent conditions included high cholestrol, gerd, latex allergy, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient has no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gerd, and atorvastatin calcium for high cholestrol. On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On JUN-2021, the subject experienced swelling under the arm. On 04-JUN-2021, the subject experienced chills. On 04-JUN-2021, the subject experienced temperature elevated. On 04-JUN-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 05-JUN-2021, the subject experienced edema. On 05-JUN-2021, the subject experienced fatigue. On 05-JUN-2021, the subject experienced sick to stomach/nausea. On 05-JUN-2021, the subject experienced pain at injection site. On 06-JUN-2021, the subject experienced coughing up brown mucus initially which is now greenish white. On 06-JUN-2021, the subject experienced right sided earache. On 06-JUN-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick to stomach/nausea on 07-JUN-2021, was recovering from bad headache, chills, edema, right sided earache, and pain at injection site, had not recovered from temperature elevated, fatigue, coughing up brown mucus initially which is now greenish white, and sore throat, and the outcome of swelling under the arm was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral swelling, Productive cough
Clinical narrative: SORE THROAT; COUGHING UP BROWN MUCUS INITIALLY WHICH IS NOW GREENISH WHITE; RIGHT SIDED EARACHE; FATIGUE; SICK TO STOMACH/NAUSEA; PAIN AT INJECTION SITE; EDEMA; CHILLS; TEMPERATURE ELEVATED; BAD HEADACHE; SWELLING UNDER THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 175 pounds, and height was 68 inches. The patient's past medical history included covid-19 infection, and concurrent conditions included high cholestrol, gerd, latex allergy, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient has no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gerd, and atorvastatin calcium for high cholestrol. On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On JUN-2021, the subject experienced swelling under the arm. On 04-JUN-2021, the subject experienced chills. On 04-JUN-2021, the subject experienced temperature elevated. On 04-JUN-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 05-JUN-2021, the subject experienced edema. On 05-JUN-2021, the subject experienced fatigue. On 05-JUN-2021, the subject experienced sick to stomach/nausea. On 05-JUN-2021, the subject experienced pain at injection site. On 06-JUN-2021, the subject experienced coughing up brown mucus initially which is now greenish white. On 06-JUN-2021, the subject experienced right sided earache. On 06-JUN-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick to stomach/nausea on 07-JUN-2021, was recovering from bad headache, chills, edema, right sided earache, and pain at injection site, had not recovered from temperature elevated, fatigue, coughing up brown mucus initially which is now greenish white, and sore throat, and the outcome of swelling under the arm was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Retching, Vomiting
Clinical narrative: VOMIT(UNABLE TO KEEP SOLID FOODS IN); DIZZINESS; DRY HEAVING(NAUSEA); JOINT PAIN; HEADACHES; This spontaneous report received from a consumer 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: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced vomit (unable to keep solid foods in). On 01-JUN-2021, the subject experienced dizziness. On 01-JUN-2021, the subject experienced dry heaving (nausea). On 01-JUN-2021, the subject experienced joint pain. On 01-JUN-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, dizziness, vomit(unable to keep solid foods in), dry heaving(nausea), and joint pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed non-serious
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash papular
Clinical narrative: RASH IS  BLOTCHY; RASH IS SLIGHTLY RAISED; RASH APPEARED ALL OVER BODY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to iodine for x-rays. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUN-2021, the subject experienced rash is blotchy. On 08-JUN-2021, the subject experienced rash is slightly raised. On 08-JUN-2021, the subject experienced rash appeared all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash appeared all over body, rash is blotchy, and rash is slightly raised. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old male. Initial information was processed with additional information received on 10-JUN-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: 202821A, expiry: UNKNOWN) frequency 1 total, dose was not reported, administered to right deltoid on 08-APR-2021 13:00 for prophylactic vaccination. Concomitant medications included guselkumab.  Consumer called to report that he had an antibody test for 2 types of antibodies (he did not remember the type of test) on 07-JUN-2021. His Doctor called him on 08-JUN-2021, to tell him that the test results were negative for both (coded as confirmed immunological vaccine failure). He was extremely agitated and did not want to answer questions. Patient was on Tremfya and had been for about 1 year. Patient did yell and cuss before he disconnected the call. On 07-JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) negative for both.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. 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: 90000182258 The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210616652- covid-19 vaccine ad26.cov2.s- confirmed 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: Hypokinesia
Clinical narrative: UNABLE TO OPEN LEFT HAND FULLY; This spontaneous report received from a patient concerned a 51 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, and batch number: 1808986 expiry: 04-JUL-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced unable to open left hand fully. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to open left hand fully. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) 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 chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210623950.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; COUGHING; This spontaneous report received from a patient concerned a 19 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: Unknown) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced shortness of breath. On 28-MAY-2021, the subject experienced coughing. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and coughing on 06-JUN-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POTENTIAL ADMINISTRATION ERROR /ADMINISTRATION OF AN EXPIRED VACCINE; TEMPERATURE EXCURSION (INCORRECT PRODUCT STORAGE); This spontaneous report received from a physician 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: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced potential administration error /administration of an expired vaccine. On 07-JUN-2021, the subject experienced temperature excursion (incorrect product storage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential administration error /administration of an expired vaccine and temperature excursion (incorrect product storage) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210616693, 20210616952 and 20210617048.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: BLACKED OUT; This spontaneous report received from a 33 year old female patient via a company representative. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included egg retrieval and was also on prescription pain relievers. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total administered on 06-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-JUN-2021, Around 3:00 pm, patient was in bed with chills and soaking with sweat. Patient stood up and immediately started losing vision and hearing. Patient felt like was going to faint and felt like may had blacked out for a bit as when patient came and was standing in another part of home and does not remembered how she got there. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blacked out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210617061-COVID-19 VACCINE AD26.COV2.S-Blacked out. 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).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED JANNSEN COVID-19 VACCINE ADMINISTRATION AT 10:15 AM; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-JUN-2021 10:15 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced expired jannsen covid-19 vaccine administration at 10:15 am. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired jannsen covid-19 vaccine administration at 10:15 am was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colonoscopy, Drug ineffective, Vaccination site pain
Clinical narrative: LACK OF DRUG EFFECT; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included crohns disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1140750 expiry: UNKNOWN) 40 mg, 1 time every 7 days, from an unspecified date to 19-APR-2021 for crohns disease. 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 APR-2021, the subject experienced vaccination site pain. On 19-APR-2021, Laboratory data included: Colonoscopy (NR: not provided) not reported. On an unspecified date, the subject experienced lack of drug effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination site pain and lack of drug effect was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 antibody test negative, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 53 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, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1143015) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On MAY-2021, the subject experienced suspected immunological vaccine failure.  Laboratory data included: COVID-19 antibody test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from suspected immunological vaccine failure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210618322-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
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia, Thrombosis
Clinical narrative: BLOOD CLOT IN ARM; HARD TIME BREATHING/COULDN'T BREATH; HIGH FEVER; This spontaneous report received from a a 63-year-old female patient of unspecified of race and ethnic origin and her daughter via a traditional media  and via a company representative. The patient's height, and weight were not reported. The patient's concurrent condition included diabetes. The patient never tested positive for coronavirus disease (COVID). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, and expiry date: unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, in APR-2021, shortly after the vaccination, the patient experienced a high fever. A day later, the patient had a hard time breathing/could not breath and was rushed to the hospital (date unspecified). The patient also developed a blood clot in her arm. The doctors told the patient's kids that the patient might not recover. In a hospital bed, the patient spent 21 days on a ventilator. The patient was recovering in the hospital in the last month of MAY-2021 and was expected to leave the rehabilitation facility by the end of JUN-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, hard time breathing/couldn't breath, and blood clot in arm. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210619186-COVID-19 VACCINE AD26.COV2.S-Blood clot in arm, Hard time breathing/couldn't breath, High fever. 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).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: JANSSEN VACCINE WAS ACCIDENTALLY ADMINISTERED AFTER BEING LEFT OUT OF FRIDGE BEYOND 6 HOURS; VACCINE WAS  LEFT  OUT OF FRIDGE BEYOND 6 HOURS; This spontaneous report received from a pharmacist concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included patient had no known drug allergy and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821288, expiry: 01-AUG-2021) dose was not reported, administered on 09-JUN-2021 18:52 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced janssen vaccine was accidentally administered after being left out of fridge beyond 6 hours. On 09-JUN-2021, the subject experienced vaccine was left out of fridge beyond 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the janssen vaccine was accidentally administered after being left out of fridge beyond 6 hours and vaccine was left out of fridge beyond 6 hours was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Asthma, Feeling hot, Illness, Loss of consciousness
Clinical narrative: ASTHMA ACTING UP; SEVERE AND EXCESSIVE VOMITING; ACHES; FEELING HOT; PUPILS LOOK LIKE NEEDLES; EYE STRAIN; REALLY SICK; FAINTING; BLACKING OUT; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown Expiry: Unknown) dose was not reported, with frequency 1 total administered on 08-JUN-2021 for prophylactic vaccination. The batch number is not reported and has been requested. Concomitant medications included fluticasone propionate/salmeterol xinafoate (Aadvair) for asthma.  On JUN-2021, the patient experienced fainting which included episodes of blacking out along with aches, feeling hot, pupils look like needles, eye strain, really sick, severe and excessive vomiting not so much nausea but it was reported that patient was puked to the point of having nothing left in his stomach.  On 08-JUN-2021, post 45 minutes of vaccination the patient experienced asthma acting up. It was also reported that patient had been administered with a nebulizer (name unspecified) which did not help hime therefore he gone through the last fourth of a rescue inhaler which he had on his hand during those last 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe and excessive vomiting, fainting, blacking out, aches, feeling hot, pupils look like needles, eye strain, asthma acting up, really sick and not so much nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210619325-COVID-19 VACCINE AD26.COV2.S-fainting, blacking out. 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).
Sex: M
Vaccine: COVID19
Symptoms: Miosis, Pain, Syncope, Vomiting
Clinical narrative: ASTHMA ACTING UP; SEVERE AND EXCESSIVE VOMITING; ACHES; FEELING HOT; PUPILS LOOK LIKE NEEDLES; EYE STRAIN; REALLY SICK; FAINTING; BLACKING OUT; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown Expiry: Unknown) dose was not reported, with frequency 1 total administered on 08-JUN-2021 for prophylactic vaccination. The batch number is not reported and has been requested. Concomitant medications included fluticasone propionate/salmeterol xinafoate (Aadvair) for asthma.  On JUN-2021, the patient experienced fainting which included episodes of blacking out along with aches, feeling hot, pupils look like needles, eye strain, really sick, severe and excessive vomiting not so much nausea but it was reported that patient was puked to the point of having nothing left in his stomach.  On 08-JUN-2021, post 45 minutes of vaccination the patient experienced asthma acting up. It was also reported that patient had been administered with a nebulizer (name unspecified) which did not help hime therefore he gone through the last fourth of a rescue inhaler which he had on his hand during those last 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe and excessive vomiting, fainting, blacking out, aches, feeling hot, pupils look like needles, eye strain, asthma acting up, really sick and not so much nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210619325-COVID-19 VACCINE AD26.COV2.S-fainting, blacking out. 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).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: FEVER; HEADACHE; SHAKING LIKE ALMOST CONVULSIONS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergy and no history of epilepsy. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096 expiry: 23-JUN-2021) dose was not reported, administered on 08-JUN-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 08-JUN-2021, the subject experienced shaking like almost convulsions. On 09-JUN-2021, the subject experienced fever. On 09-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking like almost convulsions, and fever on 09-JUN-2021, and was recovering from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS/OVERALL SICK/ACHING/EXTREMELY TIRED; ALL HIT HER AT ONCE, LIKE A TON OF BRICKS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-JUN-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the subject experienced flu like symptoms/overall sick/aching/extremely tired. On 07-JUN-2021, the subject experienced all hit her at once, like a ton of bricks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms/overall sick/aching/extremely tired, and the outcome of all hit her at once, like a ton of bricks was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: LEG SWELLING/SWELLING WENT UP LEG TO KNEE; ANKLE SWELLING; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and multiple hernias, and other pre-existing medical conditions included the patient had no appendix and gall bladder. The patient experienced drug allergy when treated with naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced leg swelling/swelling went up leg to knee. On 07-JUN-2021, the subject experienced ankle swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg swelling/swelling went up leg to knee, and ankle swelling. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE SIDE EFFECTS; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe side effects. On an unspecified date, the patient died from severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210619563 - Covid-19 Vaccine Ad26.Cov2.S - Severe Side Effects. This event is considered Unassessable. The event 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.; Reported Cause(s) of Death: SEVERE SIDE EFFECTS
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age and ethnicity. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-MAY-2021, 8 weeks ago the patient got the test done through a blood draw it did not show up that patient has antibody. (confirmed immunological vaccine failure). Patient did not know what kind of test was done. Laboratory data included: On 19-MAY-2021, Blood test (NR: not provided) Did not show antibody. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210619586-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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned 34 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: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021, and dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscle twitching, Nasal congestion, Oropharyngeal pain
Clinical narrative: TWITCHING BADLY WHILE LAYING DOWN SLEEPING; NASAL CONGESTION IN THE MORNING; SORE THROAT IN THE MORNING; LEFT ARM SORENESS WHERE THE VACCINE WAS GIVEN; This spontaneous report received from a consumer concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included has pace maker, and concurrent conditions included alzheimer's disease. The patient experienced drug allergy when treated with morphine, and codeine phosphate/paracetamol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included apixaban for blood thinner.  On 09-JUN-2021, the subject experienced twitching badly while laying down sleeping. On 09-JUN-2021, the subject experienced nasal congestion in the morning. On 09-JUN-2021, the subject experienced sore throat in the morning. On 09-JUN-2021, the subject experienced left arm soreness where the vaccine was given. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasal congestion in the morning on 09-JUN-2021, had not recovered from twitching badly while laying down sleeping, and the outcome of sore throat in the morning and left arm soreness where the vaccine was given was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; FATIGUE; This spontaneous report received from a consumer concerned an 8 decade 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced suspected covid-19 infection, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210620153.; 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: Postmenopausal haemorrhage
Clinical narrative: MENSTRUATION AFTER MENOPAUSE; This spontaneous report received from a consumer concerned multiple female patients of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patients 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, 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 no. No concomitant medications were reported.  On an unspecified date, the patients experienced menstruation after menopause. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menstruation after menopause was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210619369.; Sender's Comments: V0:20210621127-COVID-19 VACCINE AD26.COV2.S-Menstruation after menopause. 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: Thrombosis
Clinical narrative: BLOOD CLOT; 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 (suspension for injection, route of admin not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient had blood clot. The action taken with covid-19 vaccine was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210621271- covid-19 vaccine Blood clot. 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).
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: WRONG VACCINE ADMINISTERED; VACCINE ADMINISTERED WHERE VACCINE LEFT OUT FROM REFRIGERATOR FOR MORE THAN 6 HOURS; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; WRONG DOSE OF 0.3 ML INSTEAD OF 0.5 ML ADMINISTERED; This spontaneous report received from a patient concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 0043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUN-2021, the subject experienced wrong vaccine administered. On 10-JUN-2021, the subject experienced vaccine administered where vaccine left out from refrigerator for more than 6 hours. On 10-JUN-2021, the subject experienced inappropriate age at vaccine administration. On 10-JUN-2021, the subject experienced wrong dose of 0.3 ml instead of 0.5 ml administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong vaccine administered, wrong dose of 0.3 ml instead of 0.5 ml administered, inappropriate age at vaccine administration and vaccine administered where vaccine left out from refrigerator for more than 6 hours was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test, Systemic inflammatory response syndrome
Clinical narrative: PNEUMONIA; MULTISYMPTOM INFLAMMATION SYNDROME; This spontaneous report received from a consumer concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and not aware of previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, one total administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Consumer called to report patient developed multi-symptom inflammation syndrome after received the Janssen Covid-19 Vaccine and experienced pneumonia. Reporter was looked to get information regarding compensation for medical expenses after hospitalization. The patient was hospitalized on 23-May-2021 and discharged on 08-Jun-2021. The patient was hospitalized for 17 days. Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, and the outcome of multi symptom inflammation syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210621953-covid-19 vaccine ad26.cov2.s - Pneumonia, Multi symptom inflammation syndrome. 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).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Injection site pain, Mobility decreased, Pyrexia
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INJECTION SITE PAIN; FATIGUE; VOMITING COULD NOT KEEP ANYTHING DOWN FOR 24 HOURS STRAIGHT; LOSS OF APPETITE; COULD NOT GET OUT OF THE BED; FEVER; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included cancer of unknown primary cause, rheumatoid arthritis, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage, the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine 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: 043A21A, and expiry: Unknown) 1 total, dose was not reported, administered on 08-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included methotrexate and prednisone for rheumatoid arthritis.  On 08-APR-2021 (within 24 hours of getting the vaccine), the patient experienced vomiting (was not able to keep anything down for 24 hours straight), loss of appetite, fever, and injection site pain, and fatigue and could not get out of the bed. On 09-APR-2021, the patient started feeling injection site pain. The patient stated that she was not able to get out of the bed (could not get out of bed) from 8-APR-2021 to 11-APR-2021. The patient did not take any medications for any of the symptoms. On 20-MAY-2021, the patient was detected to have confirmed immunological vaccine failure (negative SARS-CoV-2 IgG antibody test). Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative Test result of 0.20 negative value no signs of antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On 11-APR-2021 the patient recovered from could not get out of the bed. On 12-APR-2021 the patient recovered from vomiting could not keep anything down for 24 hours straight, loss of appetite, and fever. On an unknown date the patient recovered from injection site pain. On 22-APR-2021 the patient recovered from fatigue. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210622018- Covid-19 vaccine ad26.cov2.s-Confirmed 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