chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 79 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not having any illness at the time of vaccination. patient had no history of similar events, had no adverse event after any previous vaccination(s). The patient had no history of allergy to food, drug, or vaccine, had no pre-existing acute illness 30 days prior to vaccination, had no history of hospitalization in last 30 days. The patient was not having any family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant nor breastfeeding at the time of vaccination. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered 1 in total, to the right on 11-AUG-2021 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, intramuscular, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered 1 in total to the left on 16-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced expired vaccine administered (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 19 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no illness at the time of vaccination, no history of similar events, no adverse event after any previous vaccination(s), no any food, drug, or vaccine history allergy, no any pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days with cause and had no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, administered on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220260967, 20220261014, 20220261042, 20220260995, 20220261011, 20220261030, 20220261048, 20220261000, 20220261022, 20220261024, 20220261043, 20220261039, 20220261063, 20220261092 and 20220210382.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 70 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (ciprofloxacin allergy), and other pre-existing medical conditions included: Patient had no illness at time of vaccination, no past history of similar event, no adverse event after any previous vaccination(s). Patient had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. Patient was not pregnant  and was not breastfeeding at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: Unknown) dose was not reported, dose number in series 1, 01 in total, administered on 30-MAR-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 (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, dose number in series 2, 01 in total, administered on 16-DEC-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-DEC-2021, the patient administered expired vaccine (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261011, 20220261063, 20220261042, 20220261024, 20220261000, 20220261092, 20220261014 and 20220261030.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 52 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. Patient did not report any illness at the time of vaccination. Patient had no history of similar event, had no adverse events related to previous vaccinations, no history of allergy to vaccine, drug, or food. Patient did not report any history of pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization and had no family history of any disease. On 29-APR-2021, the patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number 1805029, expiry: unknown) 1 total, to left arm 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 received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, intramuscular, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, 1 total, administered to the left arm on 21-DEC-2021 for prophylactic vaccination. The vaccine was stored at 2-8 degrees Celsius. The vaccine was removed thrice from the storage and kept out for 10 minutes. Then returned to refrigerator. The gauze/length of the needle was 25G, 1 inch. No concomitant medications were reported.  On 21-DEC-2021, the patient received expired vaccine (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261000, 20220261011, 20220261042, 20220261024, 20220261063, 20220261039, 20220261092, 20220261014 and 20220260995.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 46 year old male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no illness at the time of vaccination and no history of similar event, no history of adverse event after any previous vaccination, no pre-existing acute illness 30 days prior to vaccination, no History of hospitalization in last 30 days. Patient had no history of allergy to vaccine, drug, or food and no family history of any disease (relevant to vaccination) or allergy. On 23-MAR-2021, The patient was previously treated with covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1805018 and expiry date: unknown) dose was not reported, 1 total, administered on 23-MAR-2021 on right side for prophylactic vaccination. No adverse events reported following vaccination. It was unspecified whether patient had any adverse reaction following primary vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, (Dose number in series 2) 1 total, administered On 16-DEC-2021 on right side for prophylactic vaccination.  No concomitant medications were reported.  On 16-DEC-2021, the patient administered expired vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220261011, 20220261039, 20220261092, 20220260967, 20220261043, 20220261022, 20220261000, 20220261030, 20220260995 and 20220261042, 20220261024, 20220261048, 20220261014.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED UNINTENTIONALLY; This spontaneous report received from a pharmacist concerned a 40 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no illness at time of vaccination. Patient had no past history of similar event.  Patient had no adverse event after any previous vaccination(s). Patient had no history of allergy to vaccine, drug, or food. Patient had no pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. The patient previously received covid-19 vaccine ad26. cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: unknown) dose was not reported, (Dose number in series 01), 01 in total was administered on 23-MAR-2021 for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2.s (Dose number in series 01). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, (Dose number in series 02), 01 in total was administered on 17-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2021, expired vaccine was administered unintentionally (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered unintentionally was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220261011, 20220261063, 20220261042, 20220261024, 20220261048, 20220261000, 20220261039, 20220260967, 20220261022, 20220261030, 20220260995, 20220261014 and 20220261043.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiovascular disorder, Chest pain, Paraesthesia
Clinical narrative: TINGLING ALL ACROSS BODY; SOME CHEST PAIN; CARDIOVASCULAR ISSUES; CONTRACTED COVID; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient had no medical history and no medication taken. 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 JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On NOV-2021, the patient experienced contracted covid. On 15-NOV-2021, the patient experienced some chest pain, and cardiovascular issues. On an unspecified date, the patient experienced tingling all across body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling all across body, had not recovered from some chest pain, and cardiovascular issues, and the outcome of contracted covid was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE TWICE FOR COVID; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, administered on 13-SEP-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 01-MAR-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) Twice positive. On an unspecified date, the patient experienced tested positive twice for covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive twice for covid was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product storage error
Clinical narrative: PRODUCT PLACED INTO FREEZER SINCE 03-NOV-2021; OUT OF SPECIFICATION PRODUCT USE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced product placed into freezer since 03-nov-2021, out of specification product use, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product placed into freezer since 03-nov-2021, out of specification product use and off label use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nasopharyngitis, Therapeutic response unexpected
Clinical narrative: COLDS; DIZZINESS; UNEXPECTED THERAPEUTIC BENEFIT (RECOVERED FROM UPSET STOMACH/GASTRO SYMPTOMS); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: upset stomach, gastro symptoms, and covid, and concurrent conditions included: diabetes, and blood clots in body and brain. 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 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included rivaroxaban for blood clots. On 26-MAR-2021, the patient experienced colds, dizziness, and unexpected therapeutic benefit (recovered from upset stomach/gastro symptoms). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the colds, dizziness and unexpected therapeutic benefit (recovered from upset stomach/gastro symptoms) was not reported. The reporter and company causality between covid-19 vaccine ad26.cov2.s and colds considered as not related. 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 concerned a 26 year old white hispanic/latino male. The patient's weight was not reported and height was 70 inches. The patient's concurrent conditions included: asthma, and other pre-existing medical conditions included: The patient had allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient had J&J Covid-19 vaccine early in March-May 2021 and developed Covid-19 on 26-DEC-2022 and believes that it saved him from severe illness/hospitalization/death. The patient experience loss of taste and smell, had no appetite, cough and flu-like symptoms (suspected covid-19 infection and suspected clinical vaccination failure). 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 was associated with product quality complaint: 90000219441.; Sender's Comments: V0: 20220300887-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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test
Clinical narrative: JOINT PAIN ALL OVER (KNEE, SHOULDER, ARMS AND ELBOWS); This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, penicillin allergy, and shell fish allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 06-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-DEC-2021, the patient experienced joint pain all over (knee, shoulder, arms and elbows). Laboratory data (dates unspecified) included: Blood test (NR: not provided) RA factor more than 250. Treatment medications (dates unspecified) included: celecoxib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain all over (knee, shoulder, arms and elbows). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Musculoskeletal stiffness
Clinical narrative: MUSCLE STIFFNESS; WEAKNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-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 AUG-2021, the patient experienced muscle stiffness, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle stiffness, and weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 33 year old female of an Asian race and unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. On an unspecified date, following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient experienced felt upset, felt depressed, and had symptoms of covid which indicated suspected covid-19 infection (Dose number in series: 1). On 12-NOV-2021, 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: 1822811, expiry: 20-MAR-2022) dose was not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient experienced symptoms of covid which indicated suspected covid-19 (Dose number in series: 2). On 24-FEB-2022, Laboratory data included: unspecified COVID-19 virus test (NR: not provided) negative. Patient reported that she had no problems after the booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19. This report was non-serious. This case, involving the same patient is linked to 20220258736 (Dose number in series: 1).
Sex: F
Vaccine: COVID19
Symptoms: Hand deformity, Mobility decreased, Paraesthesia
Clinical narrative: MOBILITY AND AGILITY NEGATIVELY IMPACTED; ARTHRITIC CONTORTED HANDS; NEEDLES AND PINS IN EXTREMITIES; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 167 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any allergies or allergy to vaccine, food, drug. The patient did not have any history of drug abuse or any history of relevant pre-existing conditions. The patient was not on any other medication at the time the event started. She did not have any illness at the time of vaccination or any past medical history of similar event. She did not have any past adverse events after previous vaccinations. She did not have any history pre-existing acute illness 30 days prior to vaccination or history of hospitalization in last 30 days, with cause. She did not have any family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 and expiry: UNKNOWN) dose was not reported, administered on 12-SEP-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritic pain, and ascorbic acid for drug used for unknown indication On 14-SEP-2021, the patient experienced needles and pins in extremities and arthritic contorted hands. On an unspecified date, the patient experienced mobility and agility negatively impacted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mobility and agility negatively impacted, needles and pins in extremities, and arthritic contorted hands. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Chest pain, Chills, Computerised tomogram
Clinical narrative: CHEST PAIN; HIGH BLOOD PRESSURE; FIBRIN D DIMER HIGH; NERVOUS; LEG PAIN; LOW GRADE FEVER; FLU LIKE SYMPTOMS; CHILLS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2021, Laboratory data included: CT scan (NR: not provided) unknown. On 06-JAN-2022, the patient experienced flu like symptoms, chills, and low grade fever. On 11-JAN-2022, the patient experienced chest pain, high blood pressure, fibrin d dimer high, nervous, and leg pain. Laboratory data included: Blood pressure (NR: not provided) High, Blood test (NR: not provided) Unknown, Diagnostic ultrasound (NR: not provided) unknown, and Fibrin D dimer (NR: not provided) High. On FEB-2022, Laboratory data included: Blood test (NR: not provided) Unknown, and Fibrin D dimer (NR: not provided) D Dimer was going back up. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unknown, and Fibrin D dimer (NR: not provided) Increased to 1000. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, chills, and low grade fever, had not recovered from leg pain, and fibrin d dimer high, and the outcome of chest pain, high blood pressure and nervous was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Hypertension, Influenza like illness, Nervousness
Clinical narrative: CHEST PAIN; HIGH BLOOD PRESSURE; FIBRIN D DIMER HIGH; NERVOUS; LEG PAIN; LOW GRADE FEVER; FLU LIKE SYMPTOMS; CHILLS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2021, Laboratory data included: CT scan (NR: not provided) unknown. On 06-JAN-2022, the patient experienced flu like symptoms, chills, and low grade fever. On 11-JAN-2022, the patient experienced chest pain, high blood pressure, fibrin d dimer high, nervous, and leg pain. Laboratory data included: Blood pressure (NR: not provided) High, Blood test (NR: not provided) Unknown, Diagnostic ultrasound (NR: not provided) unknown, and Fibrin D dimer (NR: not provided) High. On FEB-2022, Laboratory data included: Blood test (NR: not provided) Unknown, and Fibrin D dimer (NR: not provided) D Dimer was going back up. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unknown, and Fibrin D dimer (NR: not provided) Increased to 1000. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, chills, and low grade fever, had not recovered from leg pain, and fibrin d dimer high, and the outcome of chest pain, high blood pressure and nervous was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Ultrasound scan
Clinical narrative: CHEST PAIN; HIGH BLOOD PRESSURE; FIBRIN D DIMER HIGH; NERVOUS; LEG PAIN; LOW GRADE FEVER; FLU LIKE SYMPTOMS; CHILLS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2021, Laboratory data included: CT scan (NR: not provided) unknown. On 06-JAN-2022, the patient experienced flu like symptoms, chills, and low grade fever. On 11-JAN-2022, the patient experienced chest pain, high blood pressure, fibrin d dimer high, nervous, and leg pain. Laboratory data included: Blood pressure (NR: not provided) High, Blood test (NR: not provided) Unknown, Diagnostic ultrasound (NR: not provided) unknown, and Fibrin D dimer (NR: not provided) High. On FEB-2022, Laboratory data included: Blood test (NR: not provided) Unknown, and Fibrin D dimer (NR: not provided) D Dimer was going back up. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unknown, and Fibrin D dimer (NR: not provided) Increased to 1000. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, chills, and low grade fever, had not recovered from leg pain, and fibrin d dimer high, and the outcome of chest pain, high blood pressure and nervous was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hemiparesis
Clinical narrative: BELL'S PALSY; RIGHT SIDED WEAKNESS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAR-2022, the patient visited physician office for right side weakness and experienced the bell's palsy and referred to emergency room. The patient was hospitalized on the same day. The number of hospitalization days were not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bell's palsy, and right sided weakness. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220302503- covid-19 vaccine ad26.cov2.s-bell's palsy, right sided weakness. 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: COVID-19
Clinical narrative: GOT COVID; 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 got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000219694.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: PASSING OUT AFTER VACCINATION; This spontaneous report received from a consumer 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 was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient passed out about fifteen minutes after receiving JNJ vaccine. It was reported that the pharmacist did not waited the usual fifteen minutes for monitoring after the vaccine administration and patient was walking around shopping when she fell and had hit her head on the floor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passing out after vaccination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220302794-Covid-19 vaccine ad26.cov2.s- passing out after vaccination.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: 21.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 21 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on 15-SEP-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-JAN-2022, the patient experienced headache, fever, runny nose and tested positive for COVID-19 (confirmed clinical vaccination failure and confirmed covid-19 infection) and was symptomatic for about 3 or 4 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on JAN-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0-20220303244-covid-19 vaccine ad26.cov2.s -Confirmed 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: Ejection fraction, Myocarditis, Troponin I
Clinical narrative: MYOCARDITIS; This spontaneous report was received from literature. This report concerned a 28 year old male of unspecified race and ethnic origin. The objective of this study was to better understand the characteristics and outcomes of the COVID-19 vaccine-related myocarditis. 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. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced myocarditis. Laboratory data (dates unspecified) included: Peak Cardiac troponin I (NR: not provided) 17.08 ng/mL, and Left ventricular ejection fraction (NR: not provided) 50 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from myocarditis in 2 days. This analysis showed that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220303900-COVID-19 VACCINE Ad26.COV2.S-Myocarditis.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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PLAQUE PSORIASIS FLARE UP; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: plaque 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 10-OCT-2021 for prophylactic vaccination. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. 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 OCT-2021, the patient experienced plaque psoriasis flare up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient was recovering from plaque psoriasis flare up. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: HEADACHE; TIREDNESS; FEELS BAD/TERRIBLE; This spontaneous report received from a patient via other company  concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque 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 15-AUG-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: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 16-AUG-2021, the patient experienced feels bad/terrible. On an unspecified date, the patient experienced headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from feels bad/terrible, headache, and tiredness. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash pruritic, Swelling of eyelid
Clinical narrative: Swollen eyelid; Itchy rash; Diarrhea; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAY-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: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis, and psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced swollen eyelid, itchy rash, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash, diarrhea, and swollen eyelid. This report was non-serious. This case, involving the same patient is linked to 20220307008.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: No reported medical history. 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) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: FEVER; NAUSEA; HEADACHES; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced fever, nausea, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, nausea, and headaches on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Peripheral swelling, X-ray
Clinical narrative: BOTH HANDS WERE SWOLLEN; FINGERS WERE SORE LIKE ARTHRITIS BUT IT WAS NOT ARTHRITIS; TINGLING IN BOTH HANDS; HANDS FELL ASLEEP; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-MAY-2021, the patient experienced both hands were swollen, fingers were sore like arthritis but it was not arthritis, tingling in both hands, and hands fell asleep. Laboratory data (dates unspecified) included: X-ray (NR: not provided) shown to be fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both hands were swollen, and tingling in both hands, and the outcome of hands fell asleep and fingers were sore like arthritis but it was not arthritis was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: SWOLLEN ARM; ARM HURTS ALL THE TIME EVERY DAY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JAN-2022 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 JAN-2022, the patient experienced swollen arm, and arm hurts all the time every day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm hurts all the time every day, and the outcome of swollen arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bone marrow disorder
Clinical narrative: KILLED BONE MARROW; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and 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 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 was administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, shot killed patients bone marrow and had to get a transplant. As per reporter "JJ shot killed my bone marrow. Had to get a transplant."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of killed bone marrow was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220306933-Covid-19 vaccine ad26.cov2.s-Killed bone marrow. 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: Pain
Clinical narrative: PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pain. Treatment medications (dates unspecified) included: bacitracin zinc/neomycin/polymyxin b sulfate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain. This report was non-serious.