chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: PRIMARY AND BOOSTER DOSE IT WAS NO LONGER IN THEIR  SYSTEM; This spontaneous report received from a pharmacist concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received from on 20-JUL-2022. The patient's height, and weight were not reported. The patient's past medical history included: transplant, and concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, it was reported that after receiving the Janssen Covid19 vaccine, Primary and booster dose it was no longer in the system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of primary and booster dose it was no longer in their system was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000242725. This case, involving the same patient is linked to 20220742370. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0-20220735351-covid-19 vaccine ad26.cov2.s-Primary and booster dose it was no longer in their system. 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: MEDICAL HISTORY (immunocompromised), SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: PHYSICAL SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced physical symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from physical symptoms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION(FEVERISH NIGHT SWEATS, SWEATING OUT MY FEET, AND FEEL NAUSEOUS); This spontaneous report received from a patient concerned a patient of unspecified age and sex.  The patient's height, and weight were not reported. The patient's concurrent conditions included: Crohn's disease, enteropathic arthritis, asthma, and drug allergy (Patient had drug allergy of Remicade (infliximab), lmuran (azathioprine), Humira (adalimumab)). 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 02-JUN-2020 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included budesonide/formoterol fumarate, famotidine, paracetamol, salbutamol, and valaciclovir hydrochloride. On 04-JUL-2022, the patient experienced suspected covid-19 infection (feverish night sweats, sweating out my feet, and feel nauseous). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection (feverish night sweats, sweating out my feet, and feel nauseous). This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, 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 via other manufacturer (Pfizer) concerned a 55 year old female. Initial information was processed along with the additional information received on 20-JUL-2022. The patient's height, weight, no past medical history or concurrent conditions were reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: unknown) dose was not reported, 1 total, administered on 11-MAR-2021 at right arm for covid-19 prophylaxis. Age at time of vaccination 55 years old. No concomitant medications were reported.  The patient additionally received two doses of Moderna (spikevax) vaccine (elasomeran) (first dose) (dose number in series 2) (form of admin and route of admin was not reported, batch number: 017F21A, expiry: unknown) dose was not reported, administered on 26-OCT-2021 at left arm and second dose (form of admin and route of admin was not reported, batch number: 057M21A, expiry: unknown) dose not reported, administered on 29-APR-2022 at left arm for covid-19 prophylaxis. On an unspecified date in JUN-2022 patient had COVID-19 for the first time and patient received non company suspect Paxlovid (form of admin, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, administered on 27-JUN-2022 till 01-JUL-2022 for covid-19 treatment. The patient felt better for about 5 days and tested negative, and on an unspecified date in JUL-2022, patient had started worse symptoms (confirmed covid 19 infection) (dose number in series 2) than original and tested positive again (confirmed clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with Paxlovid was drug discontinued. The patient had not recovered from confirmed covid 19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000242947.; Sender's Comments: V0-20220737071 -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: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: PRODUCT WAS THE ONE THAT'S GOING TO TAKE HER LIFE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and no alcohol use, and other pre-existing medical conditions included: The patient was a teacher for more than 30 years. 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 covid-19 prophylaxis. 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 product was the one that's going to take her life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product was the one that's going to take her life was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 36.0
Sex: M
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 via other company (Pfizer Inc.) concerned a 37 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa antibiotics allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 11-SEP-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 36 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-JUL-2022, the patient experienced confirmed covid-19 infection and had confirmed clinical vaccination failure.  The patient was treated with non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 03-JUL-2022 to 08-JUL-2022 for treatment of COVID-19.  On 13-JUL-2022, at 09:30, the patient had rebound covid-19 with sore throat and on 13-JUL-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000242966.; Sender's Comments: V0: 20220737095-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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Suspected COVID-19
Clinical narrative: ARRHYTHMIA; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hyperparathyroid, glaucoma, hypothyroid, lyme disease, osteoarthritis, and drug allergy (Timolol maleate, GTTs (drops), Levofloxacin allergy). The patient was health care professional. The patient was not pregnant at the time of vaccination. The patient previously received two doses of  Moderna COVID-19 vaccine (elasomeran) (Dose number in series 1) first dose (form of administration and route of administration were not reported , batch number: 013L20A, and expiry: unknown) dose was not reported, administered on left arm on 19-JAN-2021 at 18:00 for covid-19 prophylaxis and received second dose (form of administration and route of administration were not reported , batch number: 031L20A, and expiry: unknown) dose was not reported, administered on left arm on 16-FEB-2021 at 18:00 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following 2 doses of vaccination with Moderna COVID-19 vaccine (elasomeran) (Dose number in series 1). The patient received Pfizer (tozinameran) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: FH8020, expiry: unknown) dose was not reported, administered on left arm on 23-OCT-2021 at 13:15 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Pfizer (tozinameran) (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total administered on left arm on 07-MAY-2022 14:30 for covid-19 prophylaxis. Age at time of vaccination 54 years old. No concomitant medications were reported. On an unspecified date in 2022, the patient experienced covid-19 infection (suspected covid-19 infection) and received non company suspect paxlovid (form of administration, oral, batch number: PAA188252, expiry: unknown) dose was not reported, administered from 05-JUL-2022 to 07-jul-2022 for covid-19 treatment. On 05-JUL-2022 18:00, the patient experienced arrhythmia (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s and paxlovid was not applicable. The patient recovered from arrhythmia on 06-JUL-2022, and the outcome of suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220737469-covid-19 vaccine ad26.cov2.s-arrhythmia. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY [ hyperparathyroid, hypothyroid]. Therefore, this event(s) is considered not related.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Foot fracture, Headache, Influenza
Clinical narrative: FLU SYMPTOMS; BROKE FOOT; HEADACHE; This spontaneous report received from a patient via AbbVie concerned a 38 year old of an unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. On 13-MAY-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The age at time of vaccination was 38 years. On an unspecified date, the patient received non-company suspect drug adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) citrate free, 40 mg/0.4 ml, 1 time every 2 weeks for psoriatic arthritis. On an unspecified date, the patient experienced flu symptoms (dose number in series: 1). On an unspecified date in 2021, the patient experienced headache for a duration of four days (dose number in series: 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 2021, and the outcome of flu symptoms was not reported. On 20-SEP-2021, the patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (dose number in series: 2) (form of admin was not reported, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, administered for covid-19 prophylaxis. No concomitant medications were reported. On MAR-2022, the patient experienced broke foot (dose number in series: 2). The action taken with elasomeran was not applicable; and action taken with adalimumab was not reported. The outcome of broke foot was not reported. On 30-APR-2022, the patient received booster of non-company vaccine elasomeran (Moderna covid-19 vaccine) (dose number in series: 3) (form of admin was not reported, subcutaneous, batch number was not reported, expiry: unknown) dose was not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following elasomeran (Moderna covid-19 vaccine) (dose number in series: 3). This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis, SARS-CoV-2 test, SARS-CoV-2 test positive, Sunburn
Clinical narrative: RHEUMATOID ARTHRITIS; SUN BLISTER DUE TO OUT IN SUN A LOT; COVID-19 VIRUS TEST POSITIVE; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total (dose 1) (1 in 1 Once) administered on 09-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. Age at time of vaccination 71 years old. Concomitant medications included hydroxychloroquine and prednisone for drug used for unknown indication. On OCT-2021, the patient experienced covid-19 virus test positive (drug start period: 06 months) (Dose number in series 1). Laboratory data included: COVID-19 virus test Positive. On an unspecified date, the patient experienced rheumatoid arthritis and sun blister due to being out in sun a lot (Dose number in series 1). The patient received additional two doses of non-company suspect vaccine of tozinameran (Pfizer) (Dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: unknown) dose was not reported administered on 01-APR-2022 (second dose) and 02-MAY-2022 (booster dose) (1 in 1 Once) for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with two doses of tozinameran (Pfizer vaccine) (Dose number in series 2).  The patient had Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, citrate free, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19 virus test positive, and had not recovered from sun blister due to out in sun a lot, and rheumatoid arthritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220737512 -Covid-19 vaccine ad26.cov2.s -Rheumatoid Arthritis. 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: MEDICAL HISTORY(rheumatoid arthritis). Therefore, this event(s) is considered not related.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: UPPER LEFT SHOULDER PAIN (MINIMAL); This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old. No concomitant medications were reported.  On 2021, the patient experienced upper left shoulder pain (minimal). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper left shoulder pain (minimal) on 2021. This report was non-serious. This case, involving the same patient is linked to 20220735184.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Nipple pain, Paraesthesia, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP; SICKNESS; FOGGY FEELING IN HEAD; SORE NIPPLE; PARESTHESIA OF FINGERS; This spontaneous report received from a patient via a company representative via other company concerned an adult male of an unspecified race and ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira, adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were not reported) dose was not reported (Citrate free), 1 time every 1 day, therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced rheumatoid arthritis flare up for couple of days, sore nipple, and paresthesia of fingers. On an unspecified date patient had sickness and foggy feeling in head after covid-19 vaccine shot. 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 rheumatoid arthritis flare up, sickness, and foggy feeling in head, and had not recovered from sore nipple, and paresthesia of fingers. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220737605-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis flare up. 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
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 patient concerned a 40 year old female. Initial information was processed along with the additional information received on 21-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (with wheat and soy), and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 for covid-19 prophylaxis. Concomitant medications included beclometasone dipropionate, levocetirizine dihydrochloride, levothyroxine, montelukast, and tranexamic acid for drug used for unknown indication.  The patient received treatment with non company suspect Paxlovid (form of admin, route of admin, batch number, and expiry were not reported) dose was not reported, administered on 22-JUN-2022 for Covid-19 treatment. On an unspecified date, the patient tested negative after finishing the paxlovid then six days later she started feeling nasal congestion (confirmed covid-19 infection) and tested positive again on 11-JUL-2022 (confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with Paxlovid was treatment discontinued. The patient had not recovered from confirmed covid-19 infection, 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: 90000243164.; Sender's Comments: V0- 20220737625-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.
Age: 31.0
Sex: M
Vaccine: COVID19, 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 via other manufacturer (Pfizer) concerned a 32 year old male of unspecified race and ethnicity. Initial information was processed along with additional information on 21-JUL-2022 The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and unspecified allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered at right arm on 09-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 31 years old. The batch number was not reported and has been requested. No concomitant medications were reported. The patient additionally received non-company suspect vaccine elasomeran (moderna) (dose number in series 2) (form of admin and route of admin not reported, batch number: unknown expiry date : unknown) dose was not reported, administered at right arm on 05-NOV-2021 for covid-19 prophylaxis.   On an unspecified date in JUN-2022 patient had COVID-19 (confirmed covid-19 infection) (dose number in series 2). The patient received non-company suspect drug paxlovid (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered from 29-JUN-2022 to 04-JUL-2022 for covid-19 treatment. On 11-JUL-2022, the patient experienced rebound COVID symptoms (dose number in series 2). On 12-JUL-2022 patient tested positive with antigen test eight days after finishing paxlovid regiment which resulted to confirmed vaccination failure (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000243191.; Sender's Comments: V0-20220737632-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: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES ON HANDS AND FEET ONLY; This spontaneous report received from a consumer concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 18-JUL-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced hives on hands and feet only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives on hands and feet only was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 28-DEC-2021, the patient experienced confirmed covid-19 infection. Laboratory data included: COVID-19 antigen test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Spinal fusion acquired, X-ray
Clinical narrative: FUSION CERVICAL SPINE; This spontaneous report received from a patient via other manufacturer concerned an adult male of unspecified age, race and ethnic origin. 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 and expiry date was not reported) dose was not reported, 1 total administered on SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 44 years old. 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, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced fusion cervical spine. Laboratory data (dates unspecified) included: Magnetic resonance imaging fused neck and spine, fused neck and spine, and X-ray fused neck and spine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from fusion cervical spine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220740359-covid-19 vaccine ad26.cov2.s- fusion cervical spine. 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: M
Vaccine: COVID19
Symptoms: CSF test, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: GUILLAIN BARRE SYNDROME; HIGH GRADE FEVER; MYALGIA; This spontaneous report was received from literature report. This report concerned a 66 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total, dose 1, for covid-19 prophylaxis. 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, 2 days after vaccination the patient experienced high grade fever and myalgia. On an unspecified date 16 days after vaccination patient experienced right facial weakness which later progressed to bilateral facial paresis with difficulty in swallowing. The brain MRI (magnetic resonance imaging) was negative for acute changes and subsequently, the patient developed bilateral lower extremity weakness. The lumbar MRI revealed evidence of diffuse enhancement and mild thickening of all the nerve roots of the cauda equina. A lumbar puncture was performed, and CSF analysis showed albuminocytologic dissociation. He was diagnosed with Guillain barre syndrome (GBS), and responded to IV immunoglobuin infusions. Laboratory data (dates unspecified) included: CSF test albuminocytologic dissociation, Lumbar puncture albuminocytologic dissociation, MRI brain Negative, and Nuclear magnetic resonance imaging spinal evidence of diffuse enhancement and mild thickening of all the nerve roots of the cauda equina. Treatment medications (dates unspecified) included: immunoglobulins nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain barre syndrome, high grade fever and myalgia was not reported. Author concluded that GBS was a rare neurological disorder in which the immune system attacks nerves and can result in progressive muscle weakness, numbness, and pain. Adenovirus vector was listed as a rare side effect of COVID-19 vaccine. Author highlighted the importance of recognizing GBS as a potential side effect of the COVID-19 vaccination. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220740619 -Covid-19 vaccine ad26.cov2.s -Guillain barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: GUILLAIN BARRE SYNDROME; HIGH GRADE FEVER; MYALGIA; This spontaneous report was received from literature report. This report concerned a 66 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total, dose 1, for covid-19 prophylaxis. 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, 2 days after vaccination the patient experienced high grade fever and myalgia. On an unspecified date 16 days after vaccination patient experienced right facial weakness which later progressed to bilateral facial paresis with difficulty in swallowing. The brain MRI (magnetic resonance imaging) was negative for acute changes and subsequently, the patient developed bilateral lower extremity weakness. The lumbar MRI revealed evidence of diffuse enhancement and mild thickening of all the nerve roots of the cauda equina. A lumbar puncture was performed, and CSF analysis showed albuminocytologic dissociation. He was diagnosed with Guillain barre syndrome (GBS), and responded to IV immunoglobuin infusions. Laboratory data (dates unspecified) included: CSF test albuminocytologic dissociation, Lumbar puncture albuminocytologic dissociation, MRI brain Negative, and Nuclear magnetic resonance imaging spinal evidence of diffuse enhancement and mild thickening of all the nerve roots of the cauda equina. Treatment medications (dates unspecified) included: immunoglobulins nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain barre syndrome, high grade fever and myalgia was not reported. Author concluded that GBS was a rare neurological disorder in which the immune system attacks nerves and can result in progressive muscle weakness, numbness, and pain. Adenovirus vector was listed as a rare side effect of COVID-19 vaccine. Author highlighted the importance of recognizing GBS as a potential side effect of the COVID-19 vaccination. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220740619 -Covid-19 vaccine ad26.cov2.s -Guillain barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: NORMAL SORENESS OF THE ARM AT THE INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced normal soreness of the arm at the injection site (Dose number in series 1). The reporter called to ask which vaccine the patient should take after getting primary and booster dose with the Janssen COVID-19 vaccine during the call the reporter mentioned the patient was seeking answers to avoid getting any side effects. The caller confirmed with the reporter that the reporter means potential AE (adverse event) and not that the patient experienced an AE following JNJ vaccinations. The reporter answered by explaining that the reporter was seeking advices to know which was reporter's best choice as a vaccine following the JNJ vaccine and that the patient only had the normal soreness of the arm at the injection site nothing more or no other side effects other than that. The patient received additional covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on unspecified date for covid-19 prophylaxis. No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of normal soreness of the arm at the injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple (unspecified) patients of an unspecified age, sex.   The patient's weight, height, and medical history were not reported. The patients received previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patients had any adverse events following vaccination (Dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) (second dose), start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUN-2022, the patients experienced covid-19 infection (Dose number in series 2). The reporter reported that none of the patients had died or was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death, Illness
Clinical narrative: DIED; SICK; This spontaneous report received from a consumer concerned multiple patients of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose 1, 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. The consumer stated that there was 60 sick and 9 died out of millions from the vaccination on an unspecified date. On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died on an unspecified date, and the outcome of sick was not reported. This report was serious (Death).; Sender's Comments: V0- 20220743653 -covid-19 vaccine ad26.cov2.s- Died. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Vaccination failure
Clinical narrative: Patient received two age appropriate doses of VARIVAX. However, physician preformed titer testing, and the results showed patient is not immune to varicella; Physician preformed titer testing, and the results showed patient is not immune to varicella; This spontaneous report has been received from physician concerning a 21-years-old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, frequency, lot number, expiration date, route of administration and indication were not provided). Then, on an unknown date, she received the second dose. It was reported that it was given on an appropriated age.   On an unknown date, the physician preformed titer testing, and the results showed patient was not immune to varicella (antibody test negative, vaccination failure).  The outcome and action taken of the events was not reported.  The causal relationship between antibody test negative and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.The event vaccination failure was considered as related to the vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had never been diagnosed with/ tested positive for COVID 19. Acute illness at the time of vaccination and up to one month before was reported as none. Chronic or long standing health conditions were reported as none.  Concomitant medications details were not reported by the reporter.  Patient had received booster dose.  It was reported that patient had experienced no side effects when vaccine was administered and no side effects reported or noticed afterwards  The vaccine was moved from freezer to refrigerator the day of administration.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2022: Follow-up received on 17-Jul-2022 included updated Reporter details, patient demographics details added and narrative updated On 17-Jul-2022: Follow-up received on 17-Jul-2022 included Non-significant follow up appended
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 160.8. No concomitant medications were reported. It was reported that, the pharmacy had sent Moderna COVID-19 vaccines on 10-Jun-2022 and on the same day the vials were initially stored in refrigerator, but vaccine was given to the patient on 12-Jul-2022. The patient administered vaccine after the 30 days use date. The vials did not undergo any temperature excursions. No adverse event reported by the patient. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Follow-up received included reporter, patient and suspect product information added.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID19 after vaccination; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got COVID19 after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID19 after vaccination). At the time of the report, COVID-19 (got COVID19 after vaccination) outcome was unknown.            No concomitant products were reported. No treatment drugs were reported  It was reported that caller asked how after having COVID a patient should wait to receive the 2nd booster.  Company Comment: This spontaneous case concerns a patient (age and gender not specified) with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of event was reported as unknown. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender not specified) with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of event was reported as unknown. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.