chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; CHILLS; FEVER; This spontaneous report received from a consumer concerned a female 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 26-MAR-2021 14:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced chills, and fever. On 22-JUL-2022, the patient experienced tested positive for covid. Laboratory data included: COVID-19 virus test Positive. On 28-JUL-2022, Laboratory data included: COVID-19 virus test Positive. On 29-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 tested positive for covid, and the outcome of fever and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20220820796.
Age: 64.0
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 manufacturer (Pfizer) concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and drug allergy (not specified). The patient previously 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 28-MAY-2021 in left arm for covid-19 prophylaxis.  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 (unspecified manufacturer, dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 14-DEC-2021 in left arm for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 64 years old. Concomitant medications included acropolis met.  On an unspecified date in 2022, patient had confirmed covid-19 infection which led to confirmed clinical vaccination failure (dose number in series 2). Patient tested negative 2 times and then tested positive again 2 times 4 days apart and was still waiting on a negative test. The patient received Paxlovid (batch number: FY4422) from 27-JUL-2022 to 01-AUG-2022 for covid-19 treatment. 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 report was associated with product quality complaint.; Sender's Comments: V0: 20220844832- 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: Pain
Clinical narrative: PAIN EVERY DAY; 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 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 pain every day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain every day was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Intestinal resection
Clinical narrative: TEMPORARY BELL'S PALSY; INTESTINAL RESECTION; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total, dose 1 administered 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 an unspecified date, the patient experienced temporary bell's palsy, and had to get a portion of her intestines removed which was intestinal resection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temporary bell's palsy and intestinal resection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220845198-covid-19 vaccine ad26.cov2.s -temporary bell's palsy. This event(s) is labeled per Agency and is therefore considered potentially related.  20220845198-covid-19 vaccine ad26.cov2.s -intestinal resection . 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: Haematemesis, Total lung capacity, Total lung capacity decreased
Clinical narrative: VOMITING SHARDS OF BLOOD; HAS 1/3 OF HIS LUNG CAPACITY; This spontaneous report received from a consumer via a social media via company representative concerned a male 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 and expiry date were not reported) 1 in total, 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, it was reported that, "one of my friends has 1/3 of his lung capacity, is fighting for his life, and will likely be on blood thinners for the rest of his life. He was vomiting shards of blood. Yes, glass-looking shards of blood. Laws will not make you immune from consequences". Laboratory data (dates unspecified) included: Total lung capacity decreased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting shards of blood and has 1/3 of his lung capacity was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220845234-covid-19 vaccine ad26.cov2.s-vomiting shards of blood. 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.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Dysgeusia, Hypersensitivity
Clinical narrative: This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, GERD (gastroesophageal reflux disease), and augmentin allergy. 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 08-MAY-2021 10:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 60 years old. Concomitant medications included lisinopril dihydrate for drug used for unknown indication. On 03-AUG-2022 20:00, the patient experienced severe and persistent bitter/metallic taste in mouth, nerve hypersensitivity (unusually sensitive skin), and joint pain. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe and persistent bitter/metallic taste in mouth, nerve hypersensitivity (unusually sensitive skin), and joint pain, and the outcome of covid-19 was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Ear infection, Off label use, Otorrhoea
Clinical narrative: This spontaneous report received from a patient via another pharmaceutical company concerned a 20 year old male of an unspecified 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 had previously received 2 doses of Moderna covid-19 vaccine (elasomeran) (dose number in series 1) (form of admin not reported, intramuscular, batch number: unknown expiry: unknown) dose was not reported, administered on 15-APR-2022 (dose 1) and on 15-JUN-2020 (dose 2) for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with 2 doses of Moderna covid-19 vaccine (elasomeran) (dose number in series 1). The patient additionally received booster dose of 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 in total, administered on 11-SEP-2021 for covid-19 prophylaxis which was an off label dosing frequency (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The drug was associated with Off label use. Age at time of vaccination 19 years old. No concomitant medications were reported.  The patient received non-company suspect drugs included: adalimumab (suspension for injection in pre-filled pen, subcutaneous, batch number was not reported) Citrate free, dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. On JUL-2022, the patient experienced covid-19, ear infection, and ear discharge (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 patient had not recovered from covid-19, ear infection, and ear discharge, and the outcome of off label dosing frequency was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via Other Manufacturer concerned a 63 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received first dose with covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 15-MAR-2021 for covid-19 prophylaxis.  On an unspecified date, the patient experienced COVID-19 virus test positive (dose number in series 1). The patient was recovering from COVID-19 virus test positive. The patient received second dose with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in 2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient received third dose with covid-19 vaccine ad26.cov2.s (dose number in series 3), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 11-NOV-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use. Age at time of vaccination 63 years old.  Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220838534.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Insomnia, Mental status changes, Pain, Suspected COVID-19
Clinical narrative: PAIN; ALTERED MENTAL STATE; INTENSE INSOMNIA; ACUTE DIGESTIVE DISTRESS; SUSPECTED COVID-19 INFECTION; This spontaneous report received from other company (Pfizer, Inc) concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: neurofibromatosis type 2, and iodine allergy (if injected intravenously). The patient was not pregnant at the time of reporting. 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 in total, dose 1 administered in left arm on 01-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 47 years old. The batch number was not reported and has been requested.  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 additionally received non-company suspect vaccine tozinameran (Pfizer BioNTech covid-19 vaccine) (Dose number in series: 2) (form of admin, route of admin was not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered to left arm on 01-NOV-2021 for covid-19 prophylaxis. Concomitant medications included brigatinib. On an unspecified date in 2022, the patient experienced suspected covid-19 infection (Dose number in series: 2). The patient received (5 days of treatment) non-company suspect drug Pfizer (drug unspecified) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) from 06-AUG-2022 (Day 1) to 10-AUG-2022 (Day 5) for treatment of covid-19. On 07-AUG-2022 (Day 2), the patient experienced intense insomnia, altered mental state and Diarrhea (Dose number in series: 2). On 10-AUG-2022 (Day 5) at 10:00, the patient had acute digestive distress, pain and vomiting (Dose number in series: 2). On the same day, the patient resulted in emergency room visit and received treatment of IV (intravenous) fluids (Unspecified). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (Pfizer BioNTech covid-19 vaccine) was not applicable, and with Pfizer (drug unspecified) was not reported. The patient recovered from altered mental state, and intense insomnia on 10-AUG-2022, was recovering from acute digestive distress, and pain, and the outcome of suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220848341-covid-19 vaccine ad26.cov2.s-Acute digestive distress, Pain. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Dysphonia
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 44 year old White female. The patient's height, and weight were not reported. The patient's concurrent conditions included: COPD (Chronic obstructive pulmonary disease), and ADHD (Attention deficit hyperactivity disorder), and other 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: 1808609 expiry: unknown) dose was not reported, 01 total, administered on left arm on 20-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 43 years old. Concomitant medications included Nyquil (dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol) and Claritin/loratadine for unknown indication. 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 non-company suspect vaccine included (Moderna) elasomeran (Dose number in series 2) (Form of admin and route of admin were not reported, batch number: 012F21 A and expiry: UNKNOWN) dose was not reported, administered on left arm on 12-DEC-2021 for covid-19 prophylaxis. On an unspecified date, the patient had covid-19 for which patient took non company suspect Paxlovid (form of administration and route of admin were not reported, batch number: GE7067, expiry: unknown) dose was not reported, administered from 12-AUG-2022 for covid-19 treatment (Dose number in series 2). The patient was still in treatment. This symptom usually started right after the patient took the pills and slowly subsided until the next dose. On 13-AUG-2022, the patient experienced metallic taste in mouth, lightheaded (no fog), and hoarse voice (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable and with Paxlovid was dose maintained. The patient had not recovered from metallic taste in mouth, lightheaded (no fog), and hoarse voice. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: 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 via other manufacturer (Pfizer) concerned a 63 year old adult male of an unspecified ethnicity. Initial information was processed along with the additional information received on 24-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: severe back pain, short term memory loss, and allergy. 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: unknown, and expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 13-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 62 years old. Concomitant medications included alprazolam, and sertraline.  The patient received additional non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 035C21A , expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 to left arm for covid-19 prophylaxis. The patient was treated with Paxlovid for the treatment of covid-19 infection with the start date of 01-AUG-2022 and end date of 05-AUG-2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. On 14-AUG-2022, on the day of reporting, the patient woke up fatigued, no energy, and felt like he had a cold and retested positive after 2 prior negative tests, coded as confirmed covid-19 infection (Dose number in series 2) which led to confirmed clinical vaccination failure (Dose number in series 1). On 14-AUG-2022, Laboratory data included: COVID-19 virus test Positive. Laboratory data (dates unspecified) included: COVID-19 virus test Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0:20220848508-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccine 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a 60 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced osteoarthritis, and upper extremity dysfunction (Dose number in series 1). The patient had not recovered from osteoarthritis, and upper extremity dysfunction. The patient additionally received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number was not reported) 1 in total, dose was not reported, administered on 25-AUG-2021 for covid-19 prophylaxis which was off label dosing frequency. The drug was associated with Off label use (Dose number in series 2).  The outcome of off label dosing frequency was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, intramuscular, batch number was not reported) 1 in total, dose was not reported, administered on an unspecified date in JAN-2022 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 60 years old. No concomitant medications were reported. Non-company suspect drugs included: upadacitinib (oral, batch number: 1159488 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On an unspecified date in 2022, the patient experienced blood pressure high (Dose number in series 3). Laboratory data included: Blood pressure high.  Treatment medications (dates unspecified) included: methotrexate, and celecoxib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient had not recovered from blood pressure high. This report was non-serious.  This case, involving the same patient is linked to 20220831989 and 20220853756.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 60 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced osteoarthritis and upper extremity dysfunction (Dose number in series 1).The patient had not recovered from osteoarthritis, and upper extremity dysfunction. The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered on 25-AUG-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use (Dose number in series 2). Age at time of vaccination 60 years old. No concomitant medications were reported.  Non-company suspect drugs included: upadacitinib (oral, batch number: 1159488 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  Treatment medications (dates unspecified) included: methotrexate, and celecoxib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with upadacitinib was not reported. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220831989 and 20220853753.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days after 1st dose.) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Patient was diagnosed or tested positive for COVID-19 and type of test was unknown.  Concurrent medical conditions included Drug allergy (Imitrex), Drug allergy (Niacin), Type 2 diabetes mellitus, Congestive heart failure, Hypothyroidism, Colon cancer, Bipolar disorder, Malignant neoplasm NOS (History of malignant neoplasm), Anemia, Dementia, Hyperlipidemia, Hypokalemia and Depression. Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT) for Dementia, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, ROSUVASTATIN CALCIUM (CRESTOR) for Hyperlipidemia, POTASSIUM CHLORIDE for Hypokalemia, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, METOPROLOL, INSULIN ASPART (NOVOLOG), MEMANTINE HYDROCHLORIDE (NAMENDA), ACETYLSALICYLIC ACID (ASPIRIN 81), PANCREATIN (CREON), FENOFIBRATE, QUETIAPINE FUMARATE (SEROQUEL) and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days after 1st dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days after 1st dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days after 1st dose). Patient was taking concomitant ASA 81 concomitant for heart health. Treatment information was not provided. This case was linked to MOD-2022-628590, MOD-2022-628596 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2022: Follow up received contains significant information: Updated patient demographics, medical history and concomitant drug with indication. Narrative amended accordingly.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: diagnosed with atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (diagnosed with atrial fibrillation) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (diagnosed with atrial fibrillation) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) at a dose of UNK, blood thinner. At the time of the report, ATRIAL FIBRILLATION (diagnosed with atrial fibrillation) outcome was unknown.            No concomitant medication was reported.  It was reported that almost immediately after receiving the vaccination, patient got diagnosed with atrial fibrillation. Patient's heartbeats are erratic and needed surgery after two years. Patient had exact symptoms of myocarditis and pericarditis but it had not been diagnosed. Patient was scheduled to have an ablation.  Company comment- This spontaneous case concerns a 76-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) AESI Atrial fibrillation, which occurred at an unknown time with regards to vaccination with a second dose of mRNA-1273. After vaccination, the patient complained of erratic hearts beats and was diagnosed with atrial fibrillation. Current treatment is with Eliquis and was scheduled for ablation but claims she'll be needing surgery after 2 years. The husband stated that although her wife has the exact symptoms of myocarditis and pericarditis, she was not diagnosed with it. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) AESI Atrial fibrillation, which occurred at an unknown time with regards to vaccination with a second dose of mRNA-1273. After vaccination, the patient complained of erratic hearts beats and was diagnosed with atrial fibrillation. Current treatment is with Eliquis and was scheduled for ablation but claims she'll be needing surgery after 2 years. The husband stated that although her wife has the exact symptoms of myocarditis and pericarditis, she was not diagnosed with it. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and DRUG INEFFECTIVE (Drug ineffective) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 10-Aug-2022, the patient experienced COVID-19 (Covid-19) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (Covid-19) was resolving and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. No treatment medication were provided. It was reported that patient had COVID-19 test in Aug-2022.  Company comment: This spontaneous case concerns a 42-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 11 months and 3 weeks after receiving the third dose of mRNA-1273 vaccine.  Additionally, Drug ineffective was also reported.  The interval between the first and second doses of mRNA was noted to be 31 days. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 11 months and 3 weeks after receiving the third dose of mRNA-1273 vaccine.  Additionally, Drug ineffective was also reported.  The interval between the first and second doses of mRNA was noted to be 31 days. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Fatigue, Interchange of vaccine products
Clinical narrative: Revaccination with different Covid-19 vaccine; interchange of vaccine products; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    The patient's past medical history included Bariatric surgery in December 2020. Concurrent medical conditions included Hidradenitis suppurativa. Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.   On 20-Aug-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 20-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced FATIGUE (Fatigue). On 20-Sep-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, FATIGUE (Fatigue), COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medication were not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse event; Patient received dose 1 on 01FEB2021 and dose 2 on 17MAR2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 01FEB2021 and dose 2 on 17MAR2021) and NO ADVERSE EVENT (No Adverse event) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE, AMLODIPINE, FAMOTIDINE and RALOXIFENE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 01FEB2021 and dose 2 on 17MAR2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 01FEB2021 and dose 2 on 17MAR2021) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.     No treatment medication was provided.   This case was linked to MOD-2022-630469 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Pain of skin, Rash, Skin exfoliation, Skin hyperpigmentation
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SKIN HYPERPIGMENTATION (Big brown birth mark), BLISTER (Big blister now peeling off), PAIN OF SKIN (pain), SKIN INJURY (skin is changed) and SKIN EXFOLIATION (Big blister now peeling off) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0440224, 040a21a, 032b21a and 0214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient never had COVID positive test or diagnosis. The patient had no history of both acute and chronic illnesses at the time of vaccination. Concurrent medical conditions included Iodine allergy and Drug allergy (Amodion and a blood pressure medication). Concomitant products included Ondansetron; Metoprolol; Lactobacillus Nos; Atorvastatin Calcium; Spironolactone; Pantoprazole Sodium; Losartan Potassium; Trazodone; Tramadol; Fluoxetine; Estradiol; and Ibuprofen for an unknown indication. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced SKIN HYPERPIGMENTATION (Big brown birth mark), BLISTER (Big blister now peeling off), PAIN OF SKIN (pain), SKIN INJURY (skin is changed), SKIN EXFOLIATION (Big blister now peeling off) and RASH (broke out with birth marks on her left arm). At the time of the report, SKIN HYPERPIGMENTATION (Big brown birth mark), BLISTER (Big blister now peeling off), PAIN OF SKIN (pain), SKIN INJURY (skin is changed), SKIN EXFOLIATION (Big blister now peeling off) and RASH (broke out with birth marks on her left arm) had not resolved. On 22-Oct-2021, patient took first booster dose of Moderna COVID-19 Vaccine. On 07-Aug-2022, patient took second booster of Moderna COVID-19 Vaccine. The patient experienced one week after receiving the 2nd booster big brown birth mark, big blister now peeling off and became really noticeable which does not hurt broke out with birth marks on her left arm. The patient had not experienced a similar event in the past. It was reported that the symptoms were worse as they were peeling. No treatment medications were reported. This case was linked to MOD-2022-632934 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin injury
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SKIN HYPERPIGMENTATION (Big brown birth mark), BLISTER (Big blister now peeling off), PAIN OF SKIN (pain), SKIN INJURY (skin is changed) and SKIN EXFOLIATION (Big blister now peeling off) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0440224, 040a21a, 032b21a and 0214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient never had COVID positive test or diagnosis. The patient had no history of both acute and chronic illnesses at the time of vaccination. Concurrent medical conditions included Iodine allergy and Drug allergy (Amodion and a blood pressure medication). Concomitant products included Ondansetron; Metoprolol; Lactobacillus Nos; Atorvastatin Calcium; Spironolactone; Pantoprazole Sodium; Losartan Potassium; Trazodone; Tramadol; Fluoxetine; Estradiol; and Ibuprofen for an unknown indication. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced SKIN HYPERPIGMENTATION (Big brown birth mark), BLISTER (Big blister now peeling off), PAIN OF SKIN (pain), SKIN INJURY (skin is changed), SKIN EXFOLIATION (Big blister now peeling off) and RASH (broke out with birth marks on her left arm). At the time of the report, SKIN HYPERPIGMENTATION (Big brown birth mark), BLISTER (Big blister now peeling off), PAIN OF SKIN (pain), SKIN INJURY (skin is changed), SKIN EXFOLIATION (Big blister now peeling off) and RASH (broke out with birth marks on her left arm) had not resolved. On 22-Oct-2021, patient took first booster dose of Moderna COVID-19 Vaccine. On 07-Aug-2022, patient took second booster of Moderna COVID-19 Vaccine. The patient experienced one week after receiving the 2nd booster big brown birth mark, big blister now peeling off and became really noticeable which does not hurt broke out with birth marks on her left arm. The patient had not experienced a similar event in the past. It was reported that the symptoms were worse as they were peeling. No treatment medications were reported. This case was linked to MOD-2022-632934 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Colitis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SKIN HYPERPIGMENTATION (Big brown birth mark), BLISTER (Big blister now peeling off), PAIN OF SKIN (pain), SKIN INJURY (skin is changed) and SKIN EXFOLIATION (Big blister now peeling off) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0440224, 040a21a, 032b21a and 0214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient never had COVID positive test or diagnosis. The patient had no history of both acute and chronic illnesses at the time of vaccination. Concurrent medical conditions included Iodine allergy and Drug allergy (Amodion and a blood pressure medication). Concomitant products included Ondansetron; Metoprolol; Lactobacillus Nos; Atorvastatin Calcium; Spironolactone; Pantoprazole Sodium; Losartan Potassium; Trazodone; Tramadol; Fluoxetine; Estradiol; and Ibuprofen for an unknown indication. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced SKIN HYPERPIGMENTATION (Big brown birth mark), BLISTER (Big blister now peeling off), PAIN OF SKIN (pain), SKIN INJURY (skin is changed), SKIN EXFOLIATION (Big blister now peeling off) and RASH (broke out with birth marks on her left arm). At the time of the report, SKIN HYPERPIGMENTATION (Big brown birth mark), BLISTER (Big blister now peeling off), PAIN OF SKIN (pain), SKIN INJURY (skin is changed), SKIN EXFOLIATION (Big blister now peeling off) and RASH (broke out with birth marks on her left arm) had not resolved. On 22-Oct-2021, patient took first booster dose of Moderna COVID-19 Vaccine. On 07-Aug-2022, patient took second booster of Moderna COVID-19 Vaccine. The patient experienced one week after receiving the 2nd booster big brown birth mark, big blister now peeling off and became really noticeable which does not hurt broke out with birth marks on her left arm. The patient had not experienced a similar event in the past. It was reported that the symptoms were worse as they were peeling. No treatment medications were reported. This case was linked to MOD-2022-632934 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received expired dose; Patient received first dose on 18-MAY-2022 and second dose on 24-JUN-2022; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-MAY-2022 and second dose on 24-JUN-2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 065F21A and 053B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). 24-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-MAY-2022 and second dose on 24-JUN-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-MAY-2022 and second dose on 24-JUN-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  No relevant concomitant medications were reported. It was reported that second lot number was expired on the date that it was administered. Treatment medication was not provided by the reporter.