chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B) (batch number p7294, expiry date 3rd January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was inadvertently administrated an expired dose Engerix B, which led to expired vaccine used. No further events were reported.  The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Twinrix, two days after the expiration date, which led to expired vaccine used. Number for GlaxoSmithKline Medical Information given for future reference and warm transfer was provided. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got only one dose on june 2018; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Off label use
Clinical narrative: Expired Product Used; 63 y/o patient was given Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included stem cell transplant.   On 14th February 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and off label use. On an unknown date, the outcome of the expired vaccine used and off label use were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The patient was administered a dose of Infanrix vaccine which was expired on 06th February 2022, which led to expired vaccine used. At the time of reporting, the patient had not been re dosed. Reporter stated that, they were aware the use of Infanrix in patient this age was off label, which led to off label use.  The patient was ordered to receive the series because they underwent stem cell transplant.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026699:Same reporter. FU1 - deleted.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Thrombosis
Clinical narrative: GOT COVID; DEAD; BLOOD CLOTS SO BAD; This spontaneous report received from a consumer via a company representative via media concerned a 55-year-old male with unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and Expiry date were not reported) administered 1 total, dose and 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, as per reporter "Had a buddy that got the J and J two weeks later he got Covid 3 days later in the hospital and a month later he was dead. Said he had blood clots so bad that if he had made it he would". On an unspecified date, the patient got Covid and was hospitalized (date unspecified) and had and blood clots so bad. On an unspecified date, the patient died due to unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid and blood clots so bad was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20220217605-COVID-19 VACCINE AD26.COV2.S-Death, blood clots, got Covid. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Mass, Pruritus, Psoriatic arthropathy
Clinical narrative: PSORIATIC ARTHRITIS FLARE UP WITH PAIN; SMALL LUMP; ITCHY LUMP; RED LUMP; This spontaneous report received from a patient concerned a 53 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, administered 1 in total on 01-MAY-2022 for prophylactic vaccination. On Dec-2021, the patient was hospitalized for six days due to being sick with covid (covid-19 infection), oxygen saturation low, bilateral pneumonia, difficulty in walking and breathing and was prescribed steroids. On unknown dates, the patient experienced asthma, heart disorder and tachycardia and he also had occasional pain, muscle aches headaches and tiredness and was prescribed Amitriptyline when treated with covid-19 vaccine ad26.cov2.s (dose number in series was 1). On an unspecified date, patient was previously treated with additional dose of covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, administered 1 in total for prophylactic vaccination which is an off label use and inappropriate schedule of vaccine administered (dose number in series was 2). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 3) (suspension for injection, intramuscular, batch number and expiry: Unknown) dose was not reported, administered 1 in total on 22-JAN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. Concomitant medications included amitriptyline. In JAN-2022, the patient experienced psoriatic arthritis flare up with pain due to being off medication, small lump, itchy lump, and red lump (dose number in series was 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The patient recovered from small lump, itchy lump, and red lump, and had not recovered from psoriatic arthritis flare up with pain. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220222411. Sender's Comments: V0: 20220225398-covid-19 vaccine ad26. cov2.s-psoriatic arthritis flare up. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sinus disorder
Clinical narrative: This spontaneous report received from a patient via other company (RA) concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from an unspecified date to JAN-2022 for psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced sinus issues, and headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the sinus issues and headache was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old male of unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with BNT 162 (Pfizer) (Dose number in series:1) (form of admin, route of admin not reported, batch number: EN6208,expiry: unknown) dose was not reported, administered on 02-MAR-2021 for prophylactic vaccination, (form of admin, route of admin not reported, batch number: EM9810 ,expiry: unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No adverse event was reported with BNT 162 (Pfizer) (Dose number in series:1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series:2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total administered on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-FEB-2022, the patient experienced suspected covid-19 infection and patient tested with Binax Now test (suspected clinical vaccination failure) and Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive (Dose number in series:2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number was requested.; Sender's Comments: V0: 20220229470- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION ERROR/ VIAL WAS PUNCTURED ON 10-FEB-2022 BUT WAS ADMINISTERED TO A PATIENT NEXT DAY; INCORRECTLY STORED VACCINE ADMINISTRATED; OFF LABEL USE; 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, and batch number were not reported) dose was not reported, administered on 11-FEB-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-FEB-2022, the patient experienced administration error/ vial was punctured on 10-feb-2022 but was administered to a patient next day, incorrectly stored vaccine administrated, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error/ vial was punctured on 10-feb-2022 but was administered to a patient next day, incorrectly stored vaccine administrated and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a multiple patients (8 patient) of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The reporter stated that "I caught it from my vaccinated wife who caught it at a party where everyone was vaccinated. 8 of them caught it. My son and I both caught it and had mild symptoms. No loss of taste or smell or even a cough. No vaccines, and I have multiple issues that probably should have made me very ill at least. My vaccinated wife got very sick and lost taste and smell for 4 months. I see vaccinated people every day coming down with covid. Most tell me they were at least very ill. They're not telling you the whole truth. I was definitely less sick than most people tell me about their personal experience with vaccine side affects" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220230393. This report was associated with product quality complaint: 90000217220; Sender's Comments: V0: 20220230277-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure . 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. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Thrombosis
Clinical narrative: BLOOD CLOTS; DIFFICULTY BREATHING; PAIN; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was vaccinated with the vaccine and about one month after post injection she had difficulty breathing along with pains and Went to the emergency room and was hospitalized for the weekend and the patient was currently on medications to treat the blood clots and is doing better, number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clots, difficulty breathing, and pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220230343-covid-19 vaccine ad26.cov2.s-blood clots, difficulty breathing, pain. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, route of admin, batch number:unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced bad cold for a week and half. Patient had suspected clinical vaccination failure, and suspected covid-19 infection (Dose number in series 1). As per reporter, "My wife and I took the J&J shots. We've had 2 of them now. No after effects, barely felt the shots. We both got Covid but it was after many months, and basically we had a bad cold for a week and a half. Our friend had no shots and he ended up in the hospital for a week." The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number:unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination.It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000217260. This case, from the same reporter is linked to 20220230288.; Sender's Comments: V0: 20220230357-COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: UNPLEASANT FEELING IN THE ARMS; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced unpleasant feeling in the arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unpleasant feeling in the arms was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via a company representative via social media  concerned a male of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had a stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220230564 and 20220230385.; Sender's Comments: V0-20220230560- covid-19 vaccine ad26.cov2.s- Stroke. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Pulmonary thrombosis, Thrombosis
Clinical narrative: This spontaneous report received from a consumer via social media via a company representative concerned a 67 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy. On an unspecified date, the patient was previously treated with Covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, (dose number in series was 1), administered 1 in total for prophylactic vaccination. It was unknown whether patient had any adverse events (Dose number in series was 1). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, (Dose number in series was 2) start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots in legs, blood clots in lungs, and blood clots in brain (Dose number in series was 2). The reporter stated that "A friends mom 67 and healthy within 3 days of second shot in the ground blood clots in legs and lungs and brain things that make you go hmmmm". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in legs, blood clots in lungs and blood clots in brain was not reported.- This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220230407. Sender's Comments: V0: 20220230577-Covid-19 vaccine ad26.cov2.s-Blood clots in legs, blood clots in lungs, and blood clots in brain. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT REAL, REAL SICK; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Reporter stated, on an unspecified date "the only person that got real, real sick had all the jabs" (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got real, real sick was not reported (dose number in series 2). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Seizure
Clinical narrative: STARTED TO HAVE SEIZURES; HEALTH STARTED TO GET WORST; This spontaneous report received from a consumer from social media via company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient received the vaccine and started to have seizures, and health started to get worst. It was reported as, "After my son in law received the J and J vaccine he started to have seizures and his health started to get worst" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the started to have seizures and health started to get worst was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220231770-covid-19 vaccine ad26.cov2.s-started to have seizures. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Asymptomatic COVID-19, Lymphadenopathy, Rash
Clinical narrative: COVID WITH NO SYMPTOMS; RASH; SWOLLEN LYMPHS; This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid with no symptoms, rash, and swollen lymphs (dose number in series 2). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) antibodies greater than 2,500. It was posted that "I developed a rash and swollen lymphs after my second vaccination. My oncologist advised me to get the quantitative antibodies test to see if I needed the booster. My antibodies (greater than 2,500) are the highest they can measure on the quantitative antibodies test (higher than people who receive vaccination) so a booster is not recommended for me by my oncologist. People who have such high antibodies usually have immunity from having had covid, so I may have actually had covid with no symptoms. Some places are accepting proof of antibodies or proof of vaccination. Other places are only accepting vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, swollen lymphs and covid with no symptoms was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000217354.
Sex: M
Vaccine: COVID19
Symptoms: Critical illness
Clinical narrative: CRITICAL; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, consumer posted about an uncle who was critical and fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of critical was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220231552 and 20220231819. Sender's Comments: V0: 20220232101-COVID-19 VACCINE AD26.COV2.S-Critical. 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). Therefore, this event(s) is considered unassessable.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELL'S PALSY; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, diabetes type 2, and hypertension. The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, the patient experienced drooping of the face and was unable to close his right eye. On the same day, the patient went to the emergency room and was discharged the same day with a diagnosis of Bell's Palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bell's palsy on 15-JUN-2021. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220233633-COVID-19 VACCINE AD26.COV2.S-bell's palsy. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was 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 it was reported that "Moms neighbor got the vaccine and died that night." On an unspecified date, the patient died from an unknown cause of death. It was unspecified if an 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: 20220233703-COVID-19 VACCINE AD26.COV2.S-Death. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: NEUROLOGICAL ISSUES/NEUROLOGICAL SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced neurological issues/neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological issues/neurological symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20220234802.; Reporter's Comments: This case report concerns multiple patient's.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES ON HANDS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced shingles on my hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles on my hands was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer via social media through a company representative concerned multiple patients of an unspecified age, race and ethnicity. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, two patient's died from heart attack shortly after the vaccine. It was unspecified if an 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: 20220234086-COVID-19 VACCINE AD26.COV2.S-Heart attack. 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. Therefore, this event is considered unassessable.; Reported Cause(s) of Death: HEART ATTACK
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Thrombosis
Clinical narrative: PASSED AWAY; STROKES; BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "Just had two coworkers in three weeks of each other got strokes and blood clots one is still in Intensive care unit the other sadly passed away this weekend". On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of passed away on an unspecified date, and the outcome of strokes and blood clots was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220234488.; Sender's Comments: V0:20220234166- covid-19 vaccine ad26.cov2.s-passed away, strokes and blood clots. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Electrocardiogram normal, Goitre, Gynaecological examination normal
Clinical narrative: Delayed menstruation (1 week) Abnormal Uterine Bleeding (for 19/23 days) Heart Palpitations & increased heart rate (resting & active) Enlarged Thyroid, Cystic Nodule
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Menstruation delayed, Nodule, Palpitations
Clinical narrative: Delayed menstruation (1 week) Abnormal Uterine Bleeding (for 19/23 days) Heart Palpitations & increased heart rate (resting & active) Enlarged Thyroid, Cystic Nodule
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound thyroid abnormal, Uterine haemorrhage
Clinical narrative: Delayed menstruation (1 week) Abnormal Uterine Bleeding (for 19/23 days) Heart Palpitations & increased heart rate (resting & active) Enlarged Thyroid, Cystic Nodule
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer via a company representative from social media concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus. 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. Concomitant medications included hydroxychloroquine for lupus. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000217514.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.   On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The reporter stated, "Johnson and Johnson, killed my wife, mother of my youngest daughter". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20220235081- COVID-19 VACCINE AD26.COV2.S- Death. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: ZOMBIE AFFECT/ FEELING VERY TIRED; 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 concurrent conditions included: drug allergy. 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 MAR-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 zombie affect/ feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of zombie affect/ feeling very tired was not reported. This report was non-serious. This report was associated with product quality complaint 90000217685.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: BACK PAIN; TIRED; FLU LIKE SYMPTOMS; FELT TERRIBLE; 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, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-SEP-2021, the patient experienced flu like symptoms, felt terrible, and tired. On 11-SEP-2021, the patient experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt terrible on 05-SEP-2021, and the outcome of flu like symptoms, back pain and tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20220200435.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Anxiety, Condition aggravated, Depression, Glycosylated haemoglobin
Clinical narrative: WEIGHT GAIN AROUND MIDDLE; ANXIETY BECAME WORSE; INSULIN RESISTANCE OVERNIGHT; BRAIN FOG BECAME WORSE; DEPRESSION BECAME WORSE; FEMALE ISSUES WORSENED; HIGH A1C; NEGATIVELY IMPACTED HORMONES, FEMALE MOSTLY; MADDENING; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hormone replacement therapy, anxiety, brain fog, and depression, and other pre-existing medical conditions included: She never had a high A1C, and already follow a lower carb diet. 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 MAR-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 weight gain around middle, anxiety became worse, insulin resistance overnight, brain fog became worse, depression became worse, female issues worsened, high a1c, negatively impacted hormones, female mostly, and maddening. Laboratory data (dates unspecified) included: HbA1C (NR: not provided) high, and Lab test (NR: not provided) negatively impacted hormones. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from negatively impacted hormones, female mostly, weight gain around middle, anxiety became worse, insulin resistance overnight, brain fog became worse, depression became worse, female issues worsened, high a1c, and maddening. This report was non-serious.