chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test positive
Clinical narrative: POSSIBLE BELL'S PALSY; SENSATIONS SUCH AS TOUCH FELT GONE; NUMBNESS IN BOTH HANDS; TINGLING IN BOTH HANDS; WEAKNESS IN BOTH LEGS; ASYMPTOMATIC COVID-19; This spontaneous report was received from a 46-year-old, male patient. The patient's height, and weight were not reported. The patient's concurrent condition included penicillin allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 29-APR-2021 for prophylactic vaccination. The patient had taken the product as directed. The patient was not taking any concomitant medication.  The patient was asymptomatic for coronavirus disease (COVID-19) but got a COVID-19 test done as his daughter tested positive, and on 02-MAY-2021, he received a positive result for the COVID-19 test. On 03-MAY-2021, he developed numbness and tingling in both hands and mentioned that some sensations such as touch felt gone but he could still taste. On the same day, he also experienced weakness in both legs and stated that he couldn't even go for a jog. On 28-JUN-2021 (about 1 month before reporting), he developed intermittent numbness and tingling on the left side of his face. The patient went to his health care professional (HCP) on 23-JUL-2021 (Friday) and the HCP mentioned it could be Bell's palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in both hands, weakness in both legs, possible Bell's palsy, tingling in both hands, and sensations such as touch felt gone, and the outcome of asymptomatic covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210760472-Covid-19 vaccine ad26.cov2.s-Possible Bell's palsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Gingivitis, Therapy non-responder
Clinical narrative: INFECTIONS IN GUMS; CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) was received on 23-JUL-2021 and concerned a female of unspecified age of unknown race and ethnicity.  The patient's height, and weight were not reported. The patient is not immunosuppressant but immunocompromised with other health conditions.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in end of APR-2021 for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. One month later after the vaccination on an unspecified date in May-2021, the patient did the antibody test which turned out to be negative (confirmed immunological vaccination failure). Laboratory data included: On May-2021, Antibody test (NR: not provided) Negative.  On an unspecified date, the patient experienced infections in gums. The patient had dental appointment.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccination failure and infections in gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210760475-covid-19 vaccine ad26.cov2.s-Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: MATERNAL EXPOSURE TO VACCINE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced maternal exposure to vaccine during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in an other. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of maternal exposure to vaccine during pregnancy was not reported. This report was non-serious. This parent/child case is linked to 20210760520.
Sex: M
Vaccine: COVID19
Symptoms: Multifocal motor neuropathy
Clinical narrative: Multifocal Motor Neuropathy; This spontaneous report received from a health care professional, on behalf of her husband, and concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection in NOV-2020 which he fully recovered from within 3 weeks. The patient had no comorbidities, had never been in hospital, or had any health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unspecified) 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, reported as within a week,  the patient became paralysed, "in unbearable pain, couldn't walk or even swallow correctly" and spent his 51st birthday in the Intensive Care Unit. On an unspecified date, Guillain-Barre syndrome was diagnosed but due to the rapid progression of the illness and the severity of the symptoms diagnosis was changed to mutifocal motor neuropathy. On an unspecified date, reported as 2 and a half months later, the patient was still undergoing treatment and therapy at home. He had been unable to work and his quality of life diminished.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multifocal motor neuropathy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: This spontaneous case concerns a 50-year-old male patient with a past medical history that included covid-19 infection in NOV-2020 who experienced multifocal motor neuropathy an unspecified time after receiving the Janssen Covid-19 vaccine. It was reported that within a week of vaccination the patient became paralyzed, and was in severe pain, couldn't walk, and had difficulty swallowing. He was admitted to the Intensive Care Unit. Guillain-Barre syndrome was diagnosed but due to the rapid progression of the illness and the severity of the symptoms the diagnosis was changed to mutifocal motor neuropathy. It was reported that 2 and a half months later, the patient was still undergoing treatment and therapy at home. Information regarding other potential etiologies was insufficient, and the occurrence of mutifocal motor neuropathy could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination. Due to limited information and based solely on the reported temporal relationship, at this time the company causality is considered as related for reporting purposes.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: HALF OF HER FACE PARALYZED; This spontaneous report received from a consumer concerned a female patient 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 not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, half of patient's face was paralyzed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of half of her face paralyzed was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210760291.; Sender's Comments: V0:20210760712- covid-19 vaccine ad26.cov2.s-HALF OF HER FACE PARALYZED . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Brain neoplasm, Computerised tomogram, Creutzfeldt-Jakob disease, Lumbar puncture
Clinical narrative: CREUTZFELDT-JAKOB DISEASE; TINY TUMOR IN THE FRONT OF BRAIN; AFRAID AT NIGHT TO STAY ALONE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's weight was 230 pounds, and height was 67 inches. The patient's concurrent conditions included high blood pressure, non alcoholic, and non smoker. Patient had no known allergies, no drug abuse or illicit drug usage. Patient had always been independent, intelligent with outstanding memory The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiration date was unknown) dose was not reported,1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After 3 weeks receiving the vaccine, patient went downhill. On 29-MAR-2021, the patient had, complained of arm being numb and started forgetting things. She started having very bad memory issue, was afraid at night to stay on her own and was agitated and emotional. She also had coordination issues, could not get into the car on her own, could barely stand up from the sitting position and would go side by side when walking. She could not form an understandable sentence so she was taken to the hospital and hospitalized from 31-MAY-2021 to 17-JUN-2021. Then she was taken to Psychiatric unit and sent her home with an appointment to see a neurologist. On 03-JUL-2021, patient was found naked on the kitchen floor, she could not remember anything and nothing made sense.  She was taken back to the hospital with the ambulance and later on (unknown date) the hospital transferred her to the another hospital, at the time of reporting patient was hospitalized there. They did computerized tomography scan, Magnetic resonance imaging, lumbar puncture and blood  works but did not have any results. During hospitalization they found a tiny tumor in the front of the brain and diagnosed Creutzfeldt-Jakob disease. The hospital also said no dementia and no Alzheimer's disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny tumor in the front of brain, and creutzfeldt-jakob disease, and the outcome of afraid at night to stay alone was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210760791-covid-19 vaccine ad26.cov2.s-Creutzfeldt-jakob disease and tiny tumor in the front of brain. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Sleep terror
Clinical narrative: CREUTZFELDT-JAKOB DISEASE; TINY TUMOR IN THE FRONT OF BRAIN; AFRAID AT NIGHT TO STAY ALONE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's weight was 230 pounds, and height was 67 inches. The patient's concurrent conditions included high blood pressure, non alcoholic, and non smoker. Patient had no known allergies, no drug abuse or illicit drug usage. Patient had always been independent, intelligent with outstanding memory The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiration date was unknown) dose was not reported,1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After 3 weeks receiving the vaccine, patient went downhill. On 29-MAR-2021, the patient had, complained of arm being numb and started forgetting things. She started having very bad memory issue, was afraid at night to stay on her own and was agitated and emotional. She also had coordination issues, could not get into the car on her own, could barely stand up from the sitting position and would go side by side when walking. She could not form an understandable sentence so she was taken to the hospital and hospitalized from 31-MAY-2021 to 17-JUN-2021. Then she was taken to Psychiatric unit and sent her home with an appointment to see a neurologist. On 03-JUL-2021, patient was found naked on the kitchen floor, she could not remember anything and nothing made sense.  She was taken back to the hospital with the ambulance and later on (unknown date) the hospital transferred her to the another hospital, at the time of reporting patient was hospitalized there. They did computerized tomography scan, Magnetic resonance imaging, lumbar puncture and blood  works but did not have any results. During hospitalization they found a tiny tumor in the front of the brain and diagnosed Creutzfeldt-Jakob disease. The hospital also said no dementia and no Alzheimer's disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny tumor in the front of brain, and creutzfeldt-jakob disease, and the outcome of afraid at night to stay alone was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210760791-covid-19 vaccine ad26.cov2.s-Creutzfeldt-jakob disease and tiny tumor in the front of brain. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy partial responder
Clinical narrative: ANTIBODIES FOR COVID-19 WERE TOO LOW; This spontaneous report received from a patient concerned a 91 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included dialysis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUN-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, patient had too low antibodies for Covid-19 (therapy partial responder). Laboratory data included: COVID-19 antibody test (NR: not provided) was 3.8 on a scale of 4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibodies for Covid-19 were too low was not reported. This report was serious (Other Medically Important Condition). This report associated with product complaint number: 90000187784.; Sender's Comments: V0: 20210760822-Covid-19 vaccine ad26.cov2.S- Antibodies for Covid-19 were too low. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 56.0
Sex: F
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 consumer concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: not reported) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-JUL-2021, the patient had tested for Covid-19 infection (confirmed covid-19 infection and confirmed clinical vaccination failure). The patient reported that, she had the runny nose, coughing and headache. On 22-JUL-2021, Laboratory data included: COVID-19 virus test (NR: not provided)  was confirmed positive after two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187584. This case, from the same reporter is linked to 20210760417.; Sender's Comments: V0: 20210760895-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: COULD NOT MOVE; SORENESS; EXHAUSTION / TIRED; SORE THROAT; RUNNY NOSE; CONGESTION; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported.  The patient's past medical history included anaphylaxis reaction, leg injury, blood clot in leg, flu, sickness, and viral infection, and concurrent conditions included peanut allergy, alcohol use, and smoker, and other pre-existing medical conditions included was working a lot to the point that immune system was shut as no chance to recover, at this time was using claritin and zyrtec and developed tolerance to them and that is why not using any medication now he also stated using dayqail and nightqail at that time and was told to quit running.  The patient was previously treated with loratadine for flu, and cetirizine hydrochloride for flu.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2017, Laboratory data included: X-ray (NR: not provided) blood clot in the leg. On 08-JUL-2021, the subject experienced runny nose. On 08-JUL-2021, the subject experienced congestion. On 19-JUL-2021, the subject experienced sore throat. On an unspecified date, the subject experienced could not move, soreness, and exhaustion / tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move, soreness, runny nose, and exhaustion / tired, and had not recovered from congestion, and sore throat. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, X-ray
Clinical narrative: COULD NOT MOVE; SORENESS; EXHAUSTION / TIRED; SORE THROAT; RUNNY NOSE; CONGESTION; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported.  The patient's past medical history included anaphylaxis reaction, leg injury, blood clot in leg, flu, sickness, and viral infection, and concurrent conditions included peanut allergy, alcohol use, and smoker, and other pre-existing medical conditions included was working a lot to the point that immune system was shut as no chance to recover, at this time was using claritin and zyrtec and developed tolerance to them and that is why not using any medication now he also stated using dayqail and nightqail at that time and was told to quit running.  The patient was previously treated with loratadine for flu, and cetirizine hydrochloride for flu.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2017, Laboratory data included: X-ray (NR: not provided) blood clot in the leg. On 08-JUL-2021, the subject experienced runny nose. On 08-JUL-2021, the subject experienced congestion. On 19-JUL-2021, the subject experienced sore throat. On an unspecified date, the subject experienced could not move, soreness, and exhaustion / tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move, soreness, runny nose, and exhaustion / tired, and had not recovered from congestion, and sore throat. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Blood test, Urticaria
Clinical narrative: HIVES/RASH; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hay fever allergy, ragweed allergy, environmental allergy, occasional drinker, and non smoker, and other pre-existing medical conditions included patient did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 704A7IA, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced hives/rash. On 01-JUL-2021, Laboratory data included: Blood pressure (NR: not provided) Normal, Blood test (NR: not provided) Normal, and Cholesterol (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives/rash. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 0.3 ML DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced 0.3 ml dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 0.3 ml dose of vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210761793 and 20210755188.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: VACCINE ADMINISTERED TO 14 YEAR OLD PATIENT; PATIENT RECEIVED 0.3ML DOSE OF VACCINE INSTEAD OF 0.5 ML; This spontaneous report received from a pharmacist via a company representative concerned a 14 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered to 14 year old subject, and subject received 0.3ml dose of vaccine instead of 0.5 ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to 14 year old patient and patient received 0.3ml dose of vaccine instead of 0.5 ml was not reported. This report was non-serious. This case, from the same reporter is linked to 20210755188 and 20210761621.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, Somnolence
Clinical narrative: RUNNY NOSE; DRY COUGH; TROUBLE WAKING UP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included the patient had a shingles vaccine two weeks ago. it was reported that the patient may have been exposed to positive cases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the subject experienced runny nose. On 28-JUL-2021, the subject experienced dry cough. On 28-JUL-2021, the subject experienced trouble waking up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the runny nose, dry cough and trouble waking up was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned an elderly female. Initial information was processed with the additional information received on 29-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, four months after vaccination, the patient had negative IgM (immunoglobulin M) and negative IgG (immunoglobulin G) (confirmed immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210760356. This report was associated with product quality complaint: 90000187621.; Sender's Comments: V0:20210761815-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Chills, Insomnia, Lethargy, Pain
Clinical narrative: COULD NOT SLEEP; PRETTY ACHY; LETHARGIC; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced could not sleep, pretty achy, lethargic, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep, pretty achy, lethargic, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: MIND FOG; SERIOUS BODYACHES; CHILLS; ARM TENDER & SORE WHEN RAISED IT UP ON DOMINANT SIDE; A LOT OF FATIGUE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced arm tender & sore when raised it up on dominant side, fever, chills, serious bodyaches, mind fog, and a lot of fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tender & sore when raised it up on dominant side, fever, chills, serious bodyaches, mind fog, and a lot of fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MIND FOG; SERIOUS BODYACHES; CHILLS; ARM TENDER & SORE WHEN RAISED IT UP ON DOMINANT SIDE; A LOT OF FATIGUE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced arm tender & sore when raised it up on dominant side, fever, chills, serious bodyaches, mind fog, and a lot of fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tender & sore when raised it up on dominant side, fever, chills, serious bodyaches, mind fog, and a lot of fatigue. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Pyrexia
Clinical narrative: HANDS SWELLED UP; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced hands swelled up. On JUL-2021, the subject experienced headache. On JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of headache and hands swelled up was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a physician via a company representative concerned a patient of unspecified age and sex of unknown 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 not reported, batch number: Unknown and expiry: Unknown) dose was not reported,1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient was diagnosed with blood clot. The patient was also being seen by rheumatologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210762968- covid-19 vaccine ad26.cov2.s-Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Fatigue, Headache
Clinical narrative: STOMACH PAIN; DIARRHEA; EXTREME MUSCLE WEAKNESS; SEVERE FATIGUE; VERY BAD HEADACHE; FEVER (100.8 F) THAT IS GETTING WORSE; NAUSEA; FELT PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 positive test, and other pre-existing medical conditions included the patient was not pregnant and no breastfeeding at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 17:45 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUL-2021, the subject experienced felt pain at the injection site. On 29-JUL-2021, the subject experienced stomach pain. On 29-JUL-2021, the subject experienced diarrhea. On 29-JUL-2021, the subject experienced extreme muscle weakness. On 29-JUL-2021, the subject experienced severe fatigue. On 29-JUL-2021, the subject experienced very bad headache. On 29-JUL-2021, the subject experienced fever (100.8 f) that is getting worse. On 29-JUL-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.8 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt pain at the injection site, severe fatigue, very bad headache, fever (100.8 f) that is getting worse, extreme muscle weakness, stomach pain, nausea, and diarrhea. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscular weakness, Nausea, Pyrexia
Clinical narrative: STOMACH PAIN; DIARRHEA; EXTREME MUSCLE WEAKNESS; SEVERE FATIGUE; VERY BAD HEADACHE; FEVER (100.8 F) THAT IS GETTING WORSE; NAUSEA; FELT PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 positive test, and other pre-existing medical conditions included the patient was not pregnant and no breastfeeding at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 17:45 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUL-2021, the subject experienced felt pain at the injection site. On 29-JUL-2021, the subject experienced stomach pain. On 29-JUL-2021, the subject experienced diarrhea. On 29-JUL-2021, the subject experienced extreme muscle weakness. On 29-JUL-2021, the subject experienced severe fatigue. On 29-JUL-2021, the subject experienced very bad headache. On 29-JUL-2021, the subject experienced fever (100.8 f) that is getting worse. On 29-JUL-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.8 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt pain at the injection site, severe fatigue, very bad headache, fever (100.8 f) that is getting worse, extreme muscle weakness, stomach pain, nausea, and diarrhea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 69 year old male of unknown ethnicity. The patient's weight was 179 pounds and height was 74 inches. The patient's past medical history included heart attack and removal of gall bladder and concurrent conditions included non alcoholic, non smoker, has a pace maker and stents, hernia in the stomach and parkinson's disease. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: unknown) dose was not reported,1 total administered on 03-MAY-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  The patients cardiologist requested an antibody test on On 27-JUL-2021, which came back negative and the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210762991-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: FEELING CONGESTED; MILD FEVER; 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced feeling congested, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever and feeling congested was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: ADMINISTERED SECOND DOSE (BOOSTER) OF THE JANSSEN COVID-19 VACCINE; 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 not reported, batch number: Unk) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced administered second dose (booster) of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered second dose (booster) of the janssen covid-19 vaccine was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Discomfort, Feeling abnormal, Hyperhidrosis
Clinical narrative: BODY ACHES; FELT LOOPY; HOT AND COLD SWEATS; LESS OF AN APPETITE; SALIVATING; HOT AND COLD CHILLS; FEELING NAUSEATED; UNCOMFORTABLE; LITTLE SORE ARM; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 220 pounds, and height was 70 inches. The patient's past medical history included covid-19, and concurrent conditions included hypertension, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced rash on foot when treated with oxycodone hydrochloride/paracetamol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 14:58 for prophylactic vaccination. Concomitant medications included chlortalidone for hypertension, and lisinopril for hypertension. On 28-JUL-2021, the subject experienced uncomfortable. On 28-JUL-2021, the subject experienced little sore arm. On 29-JUL-2021, the subject experienced body aches. On 29-JUL-2021, the subject experienced felt loopy. On 29-JUL-2021, the subject experienced hot and cold sweats. On 29-JUL-2021, the subject experienced less of an appetite. On 29-JUL-2021, the subject experienced salivating. On 29-JUL-2021, the subject experienced hot and cold chills. On 29-JUL-2021, the subject experienced feeling nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling nauseated on 29-JUL-2021, had not recovered from little sore arm, body aches, hot and cold chills, felt loopy, and hot and cold sweats, and the outcome of less of an appetite, salivating and uncomfortable was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Salivary hypersecretion
Clinical narrative: BODY ACHES; FELT LOOPY; HOT AND COLD SWEATS; LESS OF AN APPETITE; SALIVATING; HOT AND COLD CHILLS; FEELING NAUSEATED; UNCOMFORTABLE; LITTLE SORE ARM; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 220 pounds, and height was 70 inches. The patient's past medical history included covid-19, and concurrent conditions included hypertension, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced rash on foot when treated with oxycodone hydrochloride/paracetamol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 14:58 for prophylactic vaccination. Concomitant medications included chlortalidone for hypertension, and lisinopril for hypertension. On 28-JUL-2021, the subject experienced uncomfortable. On 28-JUL-2021, the subject experienced little sore arm. On 29-JUL-2021, the subject experienced body aches. On 29-JUL-2021, the subject experienced felt loopy. On 29-JUL-2021, the subject experienced hot and cold sweats. On 29-JUL-2021, the subject experienced less of an appetite. On 29-JUL-2021, the subject experienced salivating. On 29-JUL-2021, the subject experienced hot and cold chills. On 29-JUL-2021, the subject experienced feeling nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling nauseated on 29-JUL-2021, had not recovered from little sore arm, body aches, hot and cold chills, felt loopy, and hot and cold sweats, and the outcome of less of an appetite, salivating and uncomfortable was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: CHEST PAIN; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Thrombophlebitis superficial, Ultrasound scan
Clinical narrative: NOT FELT RIGHT/FEEL OFF IN TERMS OF MENTAL ACUITY, CLARITY AND SHARPNESS WAS DECLINED; 5-6 CENTIMETERS OF BLOOD CLOTTING IN THE SAPHENOUS VEIN IN THE RIGHT LEG; 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, intramuscular) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced 5-6 centimeters of blood clotting in the saphenous vein in the right leg. On 20-APR-2021, the subject experienced not felt right/feel off in terms of mental acuity, clarity and sharpness was declined. On 21-MAY-2021, Laboratory data included: Ultrasound scan (NR: not provided) 5-6 centimeter clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not felt right/feel off in terms of mental acuity, clarity and sharpness was declined, and had not recovered from 5-6 centimeters of blood clotting in the saphenous vein in the right leg. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.