chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event, Exposure via breast milk, Fatigue, Somnolence
Clinical narrative: SIDE EFFECTS; VACCINE EXPOSURE VIA BREAST MILK; SLEEPY; MORE TIRED; This spontaneous report received from a consumer via other company (Moderna) concerned a female of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was non pregnant at the time of vaccine exposure. The patient's parent received covid-19 vaccine ad26.cov2.s (dose number in series 1) (dose 1) (suspension for injection, transmammary (patient's route of admin), batch number: unknown and expiry: UNKNOWN) first dose, 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. Consumer stated patient was a nursing toddler.  On an unspecified date, the patient experienced vaccine exposure via breast milk (dose number in series 1). Consumer mentioned after received all COVID-19 vaccinations, toddler experienced side effects since she was nursing at the time of vaccination (dose number in series 1). The patient's parent received first booster dose of non-company suspect Moderna covid-19 vaccine (Elasomeran) (dose number in series 2) (dose 2) (form of admin, transmammary (patient's route of admin), batch number: unknown and expiry: UNKNOWN) dose was not reported, administered on 16-DEC-2021 for prophylactic vaccination. On 17-Dec-2021, the patient became more tired than normal and sleep more (24 hours after received the Moderna booster dose) (dose number in series 2).  The patient's parent received second booster dose non-company suspect Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 3) (dose 3) (form of admin, transmammary (patient's route of admin), batch number: unknown and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2022 for prophylactic vaccination. On an unspecified date in 2022, the patient experienced side effects after the Pfizer dose also (dose number in series 3). It was reported that the patient (child), had not received any COVID-19 vaccinations at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s, Elasomeran, and Tozinameran was not applicable. The outcome of the side effects, vaccine exposure via breast milk, more tired and sleepy was not reported. This report was non-serious.    .
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Cerebrovascular accident, Ejection fraction decreased, Myocardial infarction
Clinical narrative: STROKE; HEART ATTACK; WEAK HEART; LOW EJECTION FRACTION; This spontaneous report received from a health care professional (patient's father) concerned a 55 year old male. Initial information was processed along with additional information on 24-JUN-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and was healthy and strong. Patient's father (parent) is an healthcare professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry date: 18-FEB-2022) dose was not reported, 1 total administered on 10-APR-2021 at left arm for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced stroke and was walking lopsided, heart attack, weak heart, low ejection fraction. On an unspecified date patient was hospitalized for couple of weeks. Reporter (Father) called police after finding son in apartment patient was walking lopsided and stayed in hospital for a couple of weeks then was in rehab (care center). The patient visited to physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, heart attack, weak heart, low ejection fraction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220649327-COVID-19 VACCINE AD26.COV2.S-stroke, heart attack, weak heart, low ejection fraction. 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: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Cerebrovascular accident, Cognitive disorder, Ejection fraction decreased, Electrocardiogram ambulatory
Clinical narrative: STROKE; HEART ATTACK; WEAK HEART; LOW EJECTION FRACTION; This spontaneous report received from a health care professional (patient's father) concerned a 55 year old male. Initial information was processed along with additional information on 24-JUN-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and was healthy and strong. Patient's father (parent) is an healthcare professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry date: 18-FEB-2022) dose was not reported, 1 total administered on 10-APR-2021 at left arm for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced stroke and was walking lopsided, heart attack, weak heart, low ejection fraction. On an unspecified date patient was hospitalized for couple of weeks. Reporter (Father) called police after finding son in apartment patient was walking lopsided and stayed in hospital for a couple of weeks then was in rehab (care center). The patient visited to physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, heart attack, weak heart, low ejection fraction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220649327-COVID-19 VACCINE AD26.COV2.S-stroke, heart attack, weak heart, low ejection fraction. 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: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Hypersomnia, Impaired driving ability, Impaired work ability, Memory impairment
Clinical narrative: STROKE; HEART ATTACK; WEAK HEART; LOW EJECTION FRACTION; This spontaneous report received from a health care professional (patient's father) concerned a 55 year old male. Initial information was processed along with additional information on 24-JUN-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and was healthy and strong. Patient's father (parent) is an healthcare professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry date: 18-FEB-2022) dose was not reported, 1 total administered on 10-APR-2021 at left arm for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced stroke and was walking lopsided, heart attack, weak heart, low ejection fraction. On an unspecified date patient was hospitalized for couple of weeks. Reporter (Father) called police after finding son in apartment patient was walking lopsided and stayed in hospital for a couple of weeks then was in rehab (care center). The patient visited to physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, heart attack, weak heart, low ejection fraction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220649327-COVID-19 VACCINE AD26.COV2.S-stroke, heart attack, weak heart, low ejection fraction. 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: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Speech disorder, Thalamic infarction, Visual impairment
Clinical narrative: STROKE; HEART ATTACK; WEAK HEART; LOW EJECTION FRACTION; This spontaneous report received from a health care professional (patient's father) concerned a 55 year old male. Initial information was processed along with additional information on 24-JUN-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and was healthy and strong. Patient's father (parent) is an healthcare professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry date: 18-FEB-2022) dose was not reported, 1 total administered on 10-APR-2021 at left arm for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced stroke and was walking lopsided, heart attack, weak heart, low ejection fraction. On an unspecified date patient was hospitalized for couple of weeks. Reporter (Father) called police after finding son in apartment patient was walking lopsided and stayed in hospital for a couple of weeks then was in rehab (care center). The patient visited to physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, heart attack, weak heart, low ejection fraction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220649327-COVID-19 VACCINE AD26.COV2.S-stroke, heart attack, weak heart, low ejection fraction. 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: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: VACCINE ADMINISTERED TO 16 YEAR OLD INDIVIDUAL; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. The drug was associated with Off label use. Age at time of vaccination 16 years old. No concomitant medications were reported. On 09-NOV-2021, the patient experienced vaccine administered to 16 year old individual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered to 16 year old individual was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650014, 20220649045, 20220649488, 20220649137, 20220649421, 20220649626, 20220649803, 20220649884, 20220649915 and 20220650111. This report was associated with product quality complaint: 90000237034.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; VERY BITTER/ASHY TASTE IN MOUTH; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: exercise induced asthma, and The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A expiry: unknown) 1 total, dose was not reported, administered on left arm on 11-APR-2021 for prophylactic vaccination.  On 24-OCT-2021, the patient received non-company suspect vaccine included: Moderna/ spikevax (elasomeran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 091D21A expiry: unknown) dose was not reported, administered at left arm for prophylactic vaccination.  Concomitant medications included cetirizine hydrochloride, vitamin d supplement, magnesium supplement, famotidine, salbutamol, and vitamin b complex.  On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2) and suspected clinical vaccination failure (dose number in series 1). The patient was prescribed with non-company suspect drug Paxlovid (form of admin and route of admin were not reported, batch number: GA3581, expiry: Unknown) dose was not reported administered first dose on 21-MAY-2022 and last dose on 25-MAY-2022 for treatment of covid 19. On 21-MAY-2022, 12 hours after the first dose of paxlovid, the patient experienced very bitter/ashy taste in mouth (dose number in series 2). On 29-MAY-2022, on day 9 after taking the full course of paxlovid, the patient tested negative for covid. On 30-MAY-2022, on day 10 after taking the full course of paxlovid, the patient had recurrence of symptoms (rebound covid) and tested positive on rapid test (dose number in series 2). On 09-JUN-2022, on day 20 after taking the full course of paxlovid, the patient finally tested negative on rapid test (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from suspected covid-19 infection on 09-JUN-2022, and very bitter/ashy taste in mouth on 27-MAY-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000237574.; Sender's Comments: V0:20220649475-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLE TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 18-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 18-JAN-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion, and incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion and incorrect storage of vaccine was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000237050. The suspected product quality complaint has been confirmed to be voided (this record describes a medication error regarding a potential temperature excursion with no product quality issue indicated, also janssen is not responsible for product storage in facilities out of janssen control. this record was sent for void approval and was reviewed and approved by management) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220649370, 20220649704, 20220650014, 20220649804, 20220649045, 20220650111, 20220649137, 20220649417, 20220649421, 20220649915, 20220649626, 20220650185, 20220649884 and 20220649803.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 19-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 19-JAN-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000237053. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this record describes a medication error regarding a potential temperature excursion with no product quality issue indicated, also janssen is not responsible for product storage in facilities out of janssen control) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650014, 20220649045, 20220650111, 20220649488, 20220649417, 20220649421, 20220649137, 20220649884, 20220649803, 20220649915, 20220650185 and 20220650933.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 25-FEB-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 25-FEB-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649045, 20220649137, 20220649417, 20220649421, 20220649488, 20220649626, 20220649884, 20220649915, 20220649803, 20220650014 and 20220650185.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Prostatomegaly, Renal failure
Clinical narrative: KIDNEYS STOPPED FUNCTIONING; WORSENING OF ENLARGED PROSTATE; SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: enlarged prostate. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination. It was unknown if patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s(unspecified manufacturer) (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, and batch number were not reported) dose was not reported, 1 total administered on DEC-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, the patient had a severe reaction to the vaccine, which put him in the hospital (date unspecified). His kidneys stopped functioning and his prostrate enlarged got worsen (dose number in series 2). The number of days hospitalized was not reported, and it was unspecified if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe reaction, kidneys stopped functioning and worsening of enlarged prostate was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220649710- COVID-19 VACCINE AD26.COV2.S- KIDNEYS STOPPED FUNCTIONING, WORSENING OF ENLARGED PROSTATE, SEVERE REACTION. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 05-MAR-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649370, 20220650014, 20220649704, 20220649804, 20220649045, 20220650111, 20220649417, 20220649421, 20220649137, 20220649884, 20220649488, 20220649626, 20220649915, 20220650185 and 20220650933.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; PATIENT RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 05-MAR-2022, the patient experienced patient received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649704, 20220649370, 20220650014, 20220649804, 20220649045, 20220650111, 20220649417, 20220649137, 20220649421, 20220649488, 20220649626, 20220649803, 20220649915, 20220650185 and 20220650933.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; PATIENT RECEIVED THE JANSSEN COVID-19  VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF  EXCURSION.; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 17-FEB-2022, the patient experienced patient received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649704, 20220649370, 20220650014, 20220649804, 20220649045, 20220650111, 20220649488, 20220649417, 20220649421, 20220649137, 20220649884, 20220649803, 20220649626, 20220650185 and 20220650933.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; PATIENT RECEIVED PRODUCT THAT WAS EXPOSED TO MULTIPLE TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 17-FEB-2022, the patient experienced patient received product that was exposed to multiple temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received product that was exposed to multiple temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649137, 20220649884, 20220649626, 20220649803, 20220649915 and 20220649370.
Age: 55.0
Sex: F
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 55 year old female. The patient's height, and weight were not reported. The patient is allergic to penicilln, sulfa and bactrim drugs. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: unknown) dose was not reported, 1 in total was administered to left arm on 30-MAR-2021 for prophylactic vaccination. Age at time of vaccination 55 years old. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, cetirizine hydrochloride, and ergocalciferol.  On an unspecified date, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. Treatment medications included Paxlovid (route of admin, form of admin: unknown) for 5 days, from 5-JUN-2022 to 9-JUN-2022. The patient had no symptoms on 11-JUN-2022 (day 6). On 11-JUN-2022 (day 7), Laboratory data included: COVID-19 virus test Negative. On 14-JUN-2022 (day 10), Laboratory data included: COVID-19 virus test Negative.  On 15-JUN-2022 (day 11), the patient experienced a rebound after first symptoms and were much increased. On the day of reporting, the patient still had strong symptoms of congestion and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220651789-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: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT SICK; This spontaneous report received from a patient via a company representative via social media concerned a 50 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient was healthy. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) 1 total, dose was not reported, start therapy date was not reported for prophylactic vaccination.  On an unspecified date, the patient got sick (dose number in series 1).  The patient additionally received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, 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 got sick (dose number in series 2). Patient reported, "I am I healthy 50 year old male had the covid Shots got sick the second time around worst than the first time the only reason I got the shots was because of the job I am out.now and will.never again get these shots this is bullcrap I would not recommend anybody getting these shots nobody ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20220661192.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 experienced guillain barre. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220652101-covid-19 vaccine ad26.cov2.s -guillain barre. This event(s) is labeled per agency and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient concerned a 43 year old female of unknown ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 204B21A, expiry date: 10-MAY-2022) dose was not reported, 1 total, administered on 13-FEB-2021 in left arm 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 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 not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date in FEB-2022 patient had covid-19 and also stated that it had been more than 90 days since the patient had covid-19 (coronavirus disease-19) (Dose number in Series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent via a company representative through social media concerned a 40 year old male of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 28-JUN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received two doses of covid-19 vaccine from an unspecified manufacturer (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. It was unknown whether patient had any adverse events following two doses of covid-19 vaccine from an unspecified manufacturer (dose number in series 1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (third dose) (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was 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 experienced covid (suspected covid-19 infection) and was down for a week and had suspected clinical vaccination failure (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 product quality complaint 90000237655. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220654990-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Chest pain, Influenza like illness, Joint swelling, Pain
Clinical narrative: CHEST PAIN; JOINTS FLARING UP; JOINTS SWELLING; FELT ACHES/PAINS; FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-NOV-2021, the patient experienced felt aches/pains, and flu like symptoms. On an unspecified date, the patient experienced chest pain, joints flaring up, and joints swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt aches/pains, flu like symptoms, chest pain, joints flaring up and joints swelling was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; DRY NON PRODUCTIVE COUGH; FEELING FEVERISH; LACK OF ENERGY; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. On an unspecified date, 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 were not reported, expiry: unknown) dose was not reported, 01 total administered 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 dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, 01 total administered on 16-JUN-2022 to left arm for prophylactic vaccination. Age at time of vaccination 55 years old. No concomitant medications were reported.  On 24-JUN-2022, the patient experienced sore throat, dry non productive cough, feeling feverish (Laboratory data included: Body temperature 97.9 F) and lack of energy (all events in dose number series 2). On 27-JUN-2022, Laboratory data included: Rapid antigen covid-19 home test Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, feeling feverish, dry non productive cough, and lack of energy. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: SORE THROAT; DRY NON PRODUCTIVE COUGH; FEELING FEVERISH; LACK OF ENERGY; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. On an unspecified date, 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 were not reported, expiry: unknown) dose was not reported, 01 total administered 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 dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, 01 total administered on 16-JUN-2022 to left arm for prophylactic vaccination. Age at time of vaccination 55 years old. No concomitant medications were reported.  On 24-JUN-2022, the patient experienced sore throat, dry non productive cough, feeling feverish (Laboratory data included: Body temperature 97.9 F) and lack of energy (all events in dose number series 2). On 27-JUN-2022, Laboratory data included: Rapid antigen covid-19 home test Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, feeling feverish, dry non productive cough, and lack of energy. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000237981.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Malaise
Clinical narrative: GUILLAIN-BARRE SYNDROME; FEELING UNWELL/BODY DIDNT FEEL RIGHT; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient reported that she started to not feel well shortly after. Her body didn't felt right. She went to the Emergency room and Urgent Care several times throughout the remainder of 2021. The beginning of 2022 started the same way and each time the Doctors said that it was just viral. The patient reported that On 22-MAR-2022 her body became increasingly numb from her neck down. She literally couldn't feel anything and couldn't hold anything in her hands. She lost the ability to stand and collapsed to the floor. She remembered being able to hear her husband talking but she couldn't open her eyes. An Ambulance was called and the patient was taken to the Emergency Room once again. They did a Spinal Tap, and she was admitted into the hospital for the first time. The number of days hospitalised was unspecified. After more testing to rule out Stroke, MS (multiple sclerosis), Lyme Disease she was told she had Guillen Barre Syndrome. She spent nearly two weeks in the hospital before she was moved to rehab for two weeks. She was released from rehab on 12-APR-2022 and continued therapy at home. Four weeks later she started to experience some of the same symptoms as in the beginning. Her husband took her to the doctor and they were asked to go back to the Emergency Room. The patient reported that it was worse this time. Her left arm and hand were completely useless along with both legs. She spent nearly two more weeks in the Hospital before once again being moved into a rehabilitation facility for four weeks. The patient was released on 15-JUN-2022 and was going to continue with home care for physical therapy and occupational therapy. The use of her left hand and arm had come back but not her legs and she was unable to walk. Laboratory data included: Spinal tap, not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from guillain-barre syndrome, and the outcome of feeling unwell/body didnt feel right was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220657124-covid-19 vaccine ad26.cov2.s-guillain-barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, 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 other manufacture (pfizer) concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (not specified). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 13-MAR-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. Concomitant medications included bupropion, cetirizine hydrochloride, lisdexamfetamine mesilate, and tadalafil. The patient additionally received non-company suspect Moderna (spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 939904 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 23-OCT-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. It was unknown whether patient had any adverse events following vaccination with first dose of non-company suspect Moderna (spikevax) vaccine (elasomeran) (dose number in series 2). The patient received second dose of non-company suspect Moderna (spikevax) vaccine (elasomeran) (dose number in series 3) (form of admin and route of admin were not reported, batch number: 026L21B expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 30-MAR-2022 for prophylactic vaccination. Age at time of vaccination 41 years old. On an unspecified date, the patient had Covid-19 symptoms (suspected covid-19 infection) (Dose number in series 3) which led to suspected clinical vaccination failure (Dose number in series 1).  The patient additionally received non company drug Paxlovid (form of admin, route of admin and batch number were not reported and expiry: unknown) dose was not reported, administered on 14-JUN-2022 for covid-19 treatment. Patient received last dose of Paxlovid on 19-JUN-2022. On 22-JUN-2022, the patient experienced rebound covid infection three days after completion of paxlovid. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000239917.; Sender's Comments: V0: 20220657382-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.