chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer Inc) concerned a 49 year female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Codeine). 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 on 24-APR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 48 years old. The concomitant medication included: Allegra, Flonase, lbuprofen started (product name unknown) on 30-APR-2022. The patient also received Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on 24-OCT-2021 at left arm for prophylactic vaccination. On 23-JUN-2022, the patient experienced rebound of symptoms started 5 days after ending paxlovid (suspected covid-19 infection) (Dose number in series 2) which resulted to suspected clinical vaccination failure (Dose number in series 1). On 24-JUN-2022, patient received treatment of Albuterol (salbutamol). The patient also took non company suspect paxlovid (form of admin, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered from 14-JUN-2022 to 18-JUN-2022 for covid-19 infection.  The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable and with paxlovid was drug discontinued.  The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0- 20220708748-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Device issue, Injection site pain
Clinical narrative: DEVICE ISSUE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 6 decade old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and other pre-existing medical conditions included: No reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. Age at time of vaccination 58 years old. No concomitant medications were reported. On an unspecified date, the patient experienced device issue, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from injection site pain, and device issue. 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: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crying, Frequent bowel movements, Pain
Clinical narrative: FREQUENT BOWEL MOVEMENTS; CRYING; HORRIBLE PAIN ALL OVER BODY; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. Age at time of vaccination 41 years old. No concomitant medications were reported. On an unspecified date, the patient experienced frequent bowel movements, crying, and horrible pain all over body. 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 crying, and horrible pain all over body, and had not recovered from frequent bowel movements. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: ATRIAL FIBRILLATION; This solicited report received from a patient: Janssen for XARELTO concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medication included (ELIQUIS) apixaban for an unknown indication.  On unspecified date in JUL-2021, the patient was diagnosed with atrial fibrillation. The patient received (XARELTO) rivaroxaban (film-coated tablet, route of admin, and batch number were not reported, expiry: unknown) dose and frequency were not reported from JAN-2022 for an unspecified indication. On an unknown date in APR-2022 and JUN-2022, the patient again went into atrial fibrillation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with rivaroxaban was not reported. The outcome of atrial fibrillation was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s and atrial fibrillation was related and between rivaroxaban and atrial fibrillation was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220712003-covid-19 vaccine ad26.cov2.s -Atrial fibrillation. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.  20220712003-xarelto-Atrial fibrillation. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Age: 54.0
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 concerned a 54 year old male. Initial information was processed along with the additional information received on 08-JUL-2022. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204B21A and expiry: unknown) dose was not reported, 1 total, administered on 13-DEC-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number: 211A21A expiry: Unknown) dose was not reported, 1 total administered to left arm on 13-MAR-2022 for prophylactic vaccination.  Age at time of vaccination 54 years old. No concomitant medications were reported.  The patient was tested positive for Covid after 7 weeks (/MAY/2022) following booster vaccination and it was third time the patient tested positive which was coded as confirmed covid-19 infection (dose number in series 2) and confirmed clinical vaccination failure (dose number in series 2). The first time the patient was tested positive, where the test was received at his work place and then patient had a real test at the doctors office. The patient was sick for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220714463. This report was associated with a product quality complaint: 90000241155 and 90000241159.; Sender's Comments: V0:20220712200-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, UNK
Symptoms: Colitis, Decreased appetite, Diarrhoea, Headache, Nausea
Clinical narrative: LOSS OF APPETITE; NAUSEA; DIARRHEA; VOMITING; HEADACHE; COLITIS ATTACK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis, and other pre-existing medical conditions included: Patient had no known allergies and had no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on JUN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported.  On 25-JUN-2022, the patient experienced colitis attack, and headache. On 26-JUN-2022, the patient experienced loss of appetite, nausea, diarrhea, and vomiting. 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 loss of appetite, nausea, diarrhea, and vomiting, and the outcome of colitis attack and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vomiting
Clinical narrative: LOSS OF APPETITE; NAUSEA; DIARRHEA; VOMITING; HEADACHE; COLITIS ATTACK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis, and other pre-existing medical conditions included: Patient had no known allergies and had no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on JUN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported.  On 25-JUN-2022, the patient experienced colitis attack, and headache. On 26-JUN-2022, the patient experienced loss of appetite, nausea, diarrhea, and vomiting. 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 loss of appetite, nausea, diarrhea, and vomiting, and the outcome of colitis attack and headache was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: DIZZINESS; RINGING IN THE EARS; This spontaneous report received from a patient concerned a 63 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (3-4 glasses of wine/ year), and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of any drug abuse or illicit drug usage. The patient had no illness or regular medication. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A12A expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. Age at time of vaccination 63 years old. No concomitant medications were reported. On 10-AUG-2021, the patient experienced dizziness, and ringing in the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 10-OCT-2021, and had not recovered from ringing in the ears. This report was non-serious. This case, from the same reporter is linked to 20220714877 and 20220715147.
Age: 46.0
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 health care professional via other manufacturer and concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild intermittent asthma, obesity (body mass index 35), stage 1 ovarian cancer, attention deficit hyperactivity disorder, and allergy. The patient previously received (Pfizer) tozinameran (dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Pfizer (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, administered on 15-MAR-2022 for prophylactic vaccination. Age at time of vaccination 46 years old. The batch number was not reported and has been requested. Concomitant medications included estradiol, hydroxyzine, and salbutamol sulfate. On 05-JUN-2022 the patient started symptom (confirmed covid-19 infection) (dose number in series 2) and on 07-JUN-2022 tested positive (confirmed clinical vaccination failure) (dose number in series 2). The patient additionally received non company suspect paxlovid (form of administration and route of administration were not reported and batch number: unknown, expiry: unknown) dose was not reported, administered from 08-JUN-2022 till 12-JUN-2022 for covid-19 treatment. The covid symptoms (headache, cough, fatigue, shortness of breath, chest wall pain) initially improved, however recurred and were worse than previous on 17-JUN-2022 2022 and had continued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and 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 90000241590.; Sender's Comments: V0: 20220714846 -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: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on unspecified date in MAY-2021 or JUN-2021 (exact date unknown) 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. It was unknown whether patient experienced any adverse event following vaccination with Covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Pfizer BioNTech Covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on DEC-2021 for prophylactic vaccination. On an unspecified date in JUN-2022, the patient tested positive for COVID-19 by rapid test (dose number in series 2). Laboratory data included: COVID-19 rapid POC test Positive. The action taken with Covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of Covid-19 test positive was not reported. This report was non-serious. This case was associated with a product quality complaint 90000241367.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Arthralgia, Fall, Pain in extremity, Patella fracture, Somnolence
Clinical narrative: SLEEPY; SHOULDER FRACTURE (LEFT); PAINFUL JOINTS (KNEE AND SHOULDER); PAIN IN ARM; BROKEN KNEE CAP (RIGHT); FALL; This spontaneous report received from a patient concerned a 66 year old female of 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 was previously treated with covid-19 vaccine ad26. cov2. S (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 02-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received non-company suspect drug included: Rinvoq (upadacitinib) (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 02-MAR-2021 for moderate to severe rheumatoid arthritis.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 01-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 66 years old. No concomitant medications were reported. On an unspecified date in JAN-2022, the patient experienced fell and broke right knee cap (dose number in series 2). On an unspecified date, the patient experienced sleepy, shoulder fracture (left), painful joints (knee and shoulder), and pain in arm. Patient stated that she got really sleepy and joint pain for four days after covid-19 vaccination. The patient reported going to physical therapy for knee pain and shoulder pain (dose number in series 2). The patient received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2022 for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination Moderna covid-19 vaccine (elasomeran) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and treatment with upadacitinib was withdrawn on 02-MAR-2021. The patient recovered from painful joints (knee and shoulder), was recovering from fall, shoulder fracture (left), and broken knee cap (right), and had not recovered from pain in arm, and sleepy. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Upper limb fracture
Clinical narrative: SLEEPY; SHOULDER FRACTURE (LEFT); PAINFUL JOINTS (KNEE AND SHOULDER); PAIN IN ARM; BROKEN KNEE CAP (RIGHT); FALL; This spontaneous report received from a patient concerned a 66 year old female of 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 was previously treated with covid-19 vaccine ad26. cov2. S (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 02-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received non-company suspect drug included: Rinvoq (upadacitinib) (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 02-MAR-2021 for moderate to severe rheumatoid arthritis.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 01-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 66 years old. No concomitant medications were reported. On an unspecified date in JAN-2022, the patient experienced fell and broke right knee cap (dose number in series 2). On an unspecified date, the patient experienced sleepy, shoulder fracture (left), painful joints (knee and shoulder), and pain in arm. Patient stated that she got really sleepy and joint pain for four days after covid-19 vaccination. The patient reported going to physical therapy for knee pain and shoulder pain (dose number in series 2). The patient received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2022 for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination Moderna covid-19 vaccine (elasomeran) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and treatment with upadacitinib was withdrawn on 02-MAR-2021. The patient recovered from painful joints (knee and shoulder), was recovering from fall, shoulder fracture (left), and broken knee cap (right), and had not recovered from pain in arm, and sleepy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included: something with her leg to which she was hospitalized (it was 2 years age), and concurrent conditions included: allergies (something with some sort of pain medication she could not had), blood pressure abnormal (she took blood pressure pills), smoker, and alcohol use, and other pre-existing medical conditions included: The patient had not drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 01-APR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUL-2022, patient was in the hospital and the doctors told her she had COVID-19 (confirmed covid-19 infection), she went to the hospital because she felt unwell and they did a test for her and it was positive (confirmed clinical vaccination failure), She was in the hospital since 05-JUL-2022 because she was 82 years old they kept her there. She was coughing. The number of days hospitalized was unspecified. 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 (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint number: 90000241394.; Sender's Comments: V0. 20220715152-covid-19 vaccine ad26.cov2.s -confirmed covid-19 infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.   20220715152-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, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a company representative concerned a female patient of an unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 11-JUL-2022. The patient's weight, height, and medical history were not reported. On an unspecified date in MAY-2021 or JUN-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (dose number in series: 1). On an unspecified date in DEC-2021, the patient received booster dose of non-company suspect vaccine tozinameran (Pfizer covid-19 vaccine) (dose number in series: 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2022, the patient tested positive for covid-19 in a rapid test (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report is associated with a product quality complaint: 90000241377. 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.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID 19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and codeine allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total administered on 11-MAR-2021 to the left arm for prophylactic vaccination. On an unspecified date, the patient experienced confirmed clinical vaccine failure (dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. The patient received second dose of Non-company suspect vaccine elasomeran (dose number in series 2) (moderna covid-19 vaccine )(form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 22-OCT-2021 to the left arm for prophylactic vaccination. It was unknown if patient had any adverse events following vaccination with elasomeran (dose number in series 2). The patient additionally received third dose of Non-company suspect vaccine elasomeran (moderna covid-19 vaccine) (dose number in series 3) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 04-JUN-2022 to the left arm for prophylactic vaccination. On an unspecified date, the patient experienced suspected clinical vaccine failure. The patient received paxlovid (form of admin, route of admin, batch number were not reported) administered from 23-Jun-2022 to 27-JUN-2022 for covid-19 treatment. On 28-Jun-2022 , the patient still tested positive after finishing antiviral. Concomitant medications (dates unspecified) included: olmesartan and hydrochlorothiazide. On 28-JUN-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid 19 infection and confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20220715465-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccine failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dizziness, SARS-CoV-2 test, Tinnitus
Clinical narrative: This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a female of an unspecified age, race and ethnicity. Initial information was processed along with additional information received on 08-JUL-2022. The patient's weight, height, and medical history were not reported. The patient received first dose of Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, FEB-2022, the patient caught Covid (Covid-19 infection) and tested positive for Covid (dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid-19 infection was not reported. On 25-JUN-2022, the patient received booster dose of non-company suspect vaccine tozinameran (Pfizer vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: FJ4989, expiry: UNKNOWN), dose was not reported, administered on upper left arm for prophylactic vaccination. The patient felt great on Saturday (25-JUN-2022), on same day after receiving vaccine the patient experienced dizziness (like 5 to 10 minutes worth and then the dizziness went away, after about 45 minutes or half hour the dizziness returned on 28-JUN-2022) (dose number in series 2). On 27-JUN-2022, the patient experienced tinnitus and made her nuts, when she was in a quiet room she heard it and it was driving her crazy (dose number in series 2). On 28-JUN-2022, the patient experienced chills (dose number in series 2). The action taken with tozinameran was not applicable. The patient had not recovered from tinnitus, chills and dizziness. This report was non serious. This report was associated with a product quality complaint: 90000241597. Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Nasopharyngitis
Clinical narrative: JOHNSON AND JOHNSON DID NOT HELP AT ALL; COLD; This spontaneous report received from other manufacturer (Company) via a patient concerned an adult male of unspecified age, race and ethnicity.  Initial information was processed along with additional information on 11-JUL-2022. 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, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced johnson and johnson did not help at all, and cold (Dose number in series 1).  Non-company suspect drugs included: adalimumab (form of admin was not reported, subcutaneous, batch number: Unknown, expiry: Unknown) dose was not reported, frequency, and therapy dates were not reported for an unspecified indication.   The patient also received Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin was not reported, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, start therapy date were not reported administered on an unspecified date for covid-19 vaccination.  It was unknown whether the patient experienced any adverse events following vaccination with Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the johnson and johnson did not help at all and cold was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000241676; Sender's Comments: V0: 20220716028-COVID-19 VACCINE AD26.COV2.S-johnson and johnson did not help at all. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced out of specification product use, and incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect storage of drug was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000241162
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient  of unspecified age and sex, race, ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, herpes simplex, htn (hypertension), and penicillin allergy. The patient patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201 a21 a expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, 1 total administered on 25-JAN-2022 for prophylactic vaccination. Concomitant medications included lisinopril.  On an unspecified date, the patient experienced covid-19 infection for which patient received Pfizer drug as a treatment. The patient received non-company co-suspect pfizer drug (unspecified) (form of administration, oral route of administration, batch number, and expiry were not reported) dose was not reported, administered from 18-JUN-2022 to 22-JUN-2022 for treatment of COVID-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. On 28-JUN-2022, the patient experienced recurrence of covid symptoms (captured as suspected covid-19 infection.) which leds to suspected clinical vaccination failure (Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number requested.; Sender's Comments: V0- 20220716745-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2022, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000241550.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ACHING IN RIGHT LEG FOR ABOUT 1 HOUR/ACHING IN LEFT ARM; This spontaneous report received from a patient concerned a 63 year male. 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: 1808482 expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-APR-2021 at left arm for prophylactic vaccination. Age at time of vaccination 63 years old. No concomitant medications were reported.  On 10-APR-2021, after vaccination the patient had some aching in his left arm and about 11 hours later the patient experienced some aching in his right leg for about 1 hour (aching in right leg for about 1 hour/aching in left arm) (Dose number in series 1).  The patient also received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 2112A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-OCT-2021 for prophylactic vaccination. The patient had not experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching in right leg for about 1 hour/aching in left arm on 10-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: HIVES ALL OVER THE BODY; THROAT RESTRICTED/THROAT CLOSING 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: hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2022 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2022, the patient experienced throat restricted/throat closing up. On 11-MAY-2022, the patient experienced hives all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives all over the body, and the outcome of throat restricted/throat closing up was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HORRIBLE HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced horrible headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible headaches was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 65 year old male. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with naproxen. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: unknown) dose was not reported, 1 total, first dose was administered on 01-APR-2021 10:00 on left arm for prophylactic vaccination. Age at time of vaccination 64 years old. The patient received non-company suspect vaccine included: elasomeran (moderna) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 058E21A and expiry: unknown) dose was not reported, second dose was administered on 27-OCT-2021 13:00 on right arm for prophylactic vaccination;  The patient received non-company suspect vaccine included tozinameran (Pfizer/BioNTech) (dose number in series 3) (form of admin, route of admin were not reported, batch number: FM0698 and expiry: unknown) dose was not reported, third dose was administered on 03-APR-2022 19:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 (coronavirus disease) infection (dose number in series 3) and suspected clinical vaccine failure (dose number in series 1). The patient received non-company suspect drug paxlovid (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 18-JUN-2022 to 23-JUN-2022 for covid-19 treatment. On 29-JUN-2022 07:00, the patient experienced covid rebound (positive antigen test within 5 days of completing paxlovid medication) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, tozinameran was not applicable and with paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000241804.; Sender's Comments: V0-20220719674-Covid-19 Vaccine. Ad26.Cov2.s-Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: HUGE ISSUES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 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 2021, the patient experienced huge issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of huge issues was not reported. This report was non-serious.