chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had not COVID till now. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced tired for 3 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired for 3 days on 2021. This report was non-serious. This case, involving the same patient is linked to 20220719927.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED FOR 1 DAY; This spontaneous report received from a patient via a company representative concerned a 69 year old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient's pre-existing medical conditions included: The patient had not contacted covid up to now. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, was administered on early AUG-2021 for prophylactic vaccination. On an unspecified date in 2021, the patient experienced no side effects other than tired for 3 days after shot 1 (dose number in series 1). The patient recovered from tired for 3 days in 2021. The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, was administered on first week of JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2022, the patient experienced no side effects other than tired for 1 day after shot 2 (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired for 1 day in 2022. This report was non-serious. This case, involving the same patient is linked to 20220719906.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: HAD INJECTED VACCINE THAT HAD TEMPERATURE EXCURSIONS BUT WERE OKAYED; INCORRECT PRODUCT STORAGE; 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 DEC-2021, the patient experienced had injected vaccine that had temperature excursions but were okayed, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had injected vaccine that had temperature excursions but were okayed and incorrect product storage was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; BEDRIDDEN FOR DAYS; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pretty healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 20-DEC-2021 for prophylactic vaccination. Age at time of vaccination 30 years old. No concomitant medications were reported. On 01-JAN-2022, the patient experienced confirmed covid-19 infection, and bedridden for days. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and bedridden for days on 05-JAN-2022. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: TRIGGERED DORMANT CROHN'S DISEASE; This spontaneous report received from a patient via a company representative via social media (Janssen) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: Crohns disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered 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 vaccine triggered dormant Crohn's disease.  It was reported by patient that, "That vaccine triggered my dormant Crohn's disease Janssen ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of triggered dormant Crohn's disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220721787-covid-19 vaccine ad26.cov2.s - Triggered dormant Crohn's disease. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient 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: allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, batch number, and expiry were not reported) dose was not reported, 1 total administered to left arm on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient received, non-company suspect vaccine: tozinameran (Pfizer) (dose number in series:2) (form of admin, route of admin, batch number, and expiry were not reported) dose was not reported, administered to left arm on an unspecified date in OCT-2021 for prophylactic vaccination. On an unspecified date, the patient reported tested negative after 5 days of symptoms. After 5 days of no symptoms, tested positive for covid-19 (dose number in series:2) which was confirmed covid-19 infection (dose number in series:2) and confirmed clinical vaccination failure (dose number in series:1) The patient received treatment with non company suspect (Pfizer) (form of admin, route of admin, batch number, and expiry were not reported) dose was not reported, administered from on an unspecified date in May-2022 for Covid-19 treatment. On 01-JUL-2022, Laboratory test: Covid-19 positive (rebound test device). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number requested.; Sender's Comments: V0:20220721911-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: INJECTION SITE SWOLLEN; INJECTION SITE REDNESS; This spontaneous report received from a patient via other manufacturer concerned a 6 decade old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received non-company suspect drugs included: adalimumab (form of admin was not reported, subcutaneous, batch number: unknown and expiry: unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, first dose was administered on 01-DEC-2020 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 57 years old. On an unspecified date, the patient experienced injection site swollen, and injection site redness (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, second dose was administered on 01-FEB-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The outcome of the injection site swollen and injection site redness was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: RASH ON NECK; FEVER; This spontaneous report received from a parent concerned a 37 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: autism, diabetes type 2, and inherited high cholesterol. The patient was previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (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 administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with initial dose of covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series: 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: Unknown) dose was not reported, 1 in total administered in right arm on 25-JUN-2022 for prophylactic vaccination. Age at time of vaccination 37 years old. Concomitant medications included atorvastatin calcium, fluoxetine hydrochloride, and metformin. On 28-JUN-2022 post vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced fever (Dose number in series: 2) and was resolved approximately 3 days later (JUL-2022). On 02-JUL-2022 (Week after the vaccination), the patient experienced rash on neck (Dose number in series: 2). It was reported that rash was resolved and repapered on 08-JUL-2022 (3 days ago). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on JUL-2022, and had not recovered from rash on neck. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2022, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint 90000241763.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic stroke, Hypertension
Clinical narrative: HEMORRHAGIC STROKE; HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 53 year old female. Initial information was processed along with the additional information received on 13-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, route of admin not reported, batch number: 042A21A, expiry: 16-FEB-2022) dose was not reported, 01 total administered on 05-APR-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. No concomitant medications were reported. On 24-AUG-2021, the patient experienced hemorrhagic stroke from high blood pressure. The reporter reported that the stroke had nothing to do with blood clots. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 06-SEP-2022) dose was not reported, 01 total administered on 29-NOV-2021 to the upper left arm for prophylactic vaccination. It was unknown if patient had 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 outcome of the hemorrhagic stroke and high blood pressure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint number 90000241924. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220724260.; Sender's Comments: V0: 20220724456- COVID-19 VACCINE AD26.COV2.S-hemorrhagic stroke, high blood pressure. 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: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Illness, Mobility decreased
Clinical narrative: MOBILITY DECREASED/COULD HARDLY MOVE AROUND; SICKNESS/SICK FROM COVID VACCINE; This spontaneous report received from a patient concerned a 76 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-JAN-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 rheumatoid arthritis. Age at time of vaccination 76 years old. No concomitant medications were reported. On JAN-2021, the patient experienced sickness/sick from covid vaccine. On an unspecified date, the patient experienced mobility decreased/could hardly move around. 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 mobility decreased/could hardly move around, and the outcome of sickness/sick from covid vaccine was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 42 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: penicillin allergy, erythromycin allergy, drug allergy (Dilaudid (hydromorphone), Cardura (doxazosin)), MRI dyes allergy, dairy allergy, and gluten allergy, 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: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 08:00 in right arm for prophylactic vaccination. Age at time of vaccination 41 years old. No concomitant medications were reported.   The patient additionally received non-company suspect vaccine: Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 3313OBA expiry: UNKNOWN) dose was not reported, administered on 08-JAN-2022 07:00 in left arm for prophylactic vaccination.  On 18-JUN-2022, the patient had COVID-19 virus test Positive (confirmed covid-19 infection (dose number in series 2) and confirmed clinical vaccination failure (dose number in series 1)). The patient received treatment drug for COVID as Paxlovid (nirmatrelvir and ritonavir) from 21-JUN-2022 till 25-JUN-2022. The patient was recovered form covid-19.  On 05-JUL-2022 at 06:00, the patient began getting COVID-19 symptoms again and tested positive 17 days after first positive test.  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220725227-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CONTRACTED OMICRON POST VACCINATION; 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 13-JUL-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-JUL-2022, the patient experienced contracted omicron post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of contracted omicron post vaccination was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: PAIN IN SHOULDER MUSCLE AFTER VACCINATION AND AGAIN 10 MONTHS AFTER VACCINATION; 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 SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced pain in shoulder muscle after vaccination and again 10 months after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in shoulder muscle after vaccination and again 10 months after vaccination. This report was non-serious.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: VACCINE ADMINISTRATION AT 16 YEARS OF AGE; This spontaneous report received from a consumer concerned a 16 year old of unspecified 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 OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The drug was associated with Off label use. Age at time of vaccination 16 years old. No concomitant medications were reported. On OCT-2021, the patient experienced vaccine administration at 16 years of age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administration at 16 years of age was not reported. This report was non-serious. This report is associated with a product quality complaint: 90000242127.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 02-Jun-2022; Vaccine was expired on 13-May-2022 and administered to patient on 02-Jun-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered to patient on 02-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 02-Jun-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 prophylaxis.     It was unknown if patient had ever diagnosed positive with Covid-19.  It was unknown if patient had any acute illness at the time of vaccination or up to one month before.  Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included METFORMIN HCL, LISINOPRIL and METOPROLOL for an unknown indication.    On 02-Jun-2022 at 8:10 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 02-Jun-2022 at 8:10 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered to patient on 02-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 02-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered to patient on 02-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 02-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was reported as 21-Jan-2022. Number of doses/vials was reported as 5 vails. The vial did not undergo any temperature excursions.  The vials used was kept in the refrigerator on the same day of their administration (2-Jun-2022).  Treatment information was not reported.     Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Follow-up was received and included no new information. On 23-Jun-2022: Follow-up received contain significant information include additional reporter details, patient demographics, relevant medical history, suspect product coding, dosage information, concomitant medications, event onset time and narrative updated.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis/ Chest Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis/ Chest Pain) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jun-2022, the patient experienced MYOCARDITIS (myocarditis/ Chest Pain) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (myocarditis/ Chest Pain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported by reporter.  It was reported as patient went to the ER last night with chest pain. He was now in the hospital today and was diagnosed with Myocarditis and waiting to have a cardiac MRI.  No treatment medication was reported by reporter.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 26-year-old male patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred after a dose of mRNA-1273 vaccine (latency unknown). Patient went to Emergency Room due to chest pain, and myocarditis was diagnosed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-600929 (Patient Link).; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 26-year-old male patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred after a dose of mRNA-1273 vaccine (latency unknown). Patient went to Emergency Room due to chest pain, and myocarditis was diagnosed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nerve compression, Pain, Pain in extremity
Clinical narrative: couldn't sleep; patient was told maybe had a pinched nerve and that maybe came from neck; get unbelievably pain in his arm, crying howbad the pain was on his arm; severe pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (severe pain), INSOMNIA (couldn't sleep), NERVE COMPRESSION (patient was told maybe had a pinched nerve and that maybe came from neck) and PAIN IN EXTREMITY (get unbelievably pain in his arm, crying howbad the pain was on his arm) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059a22a) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose-1) on 05-Apr-2021, Pfizer (Dose-2) on 26-Apr-2021 and Pfizer (1st Booster dose) on 06-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 21-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced PAIN (severe pain). On 05-Jul-2022, the patient experienced INSOMNIA (couldn't sleep), NERVE COMPRESSION (patient was told maybe had a pinched nerve and that maybe came from neck) and PAIN IN EXTREMITY (get unbelievably pain in his arm, crying howbad the pain was on his arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CORTISONE at a dose of cortisone in his neck; PREDNISONE at a dose of prednisone shot pack and GABAPENTIN at an unspecified dose and frequency. At the time of the report, PAIN (severe pain), INSOMNIA (couldn't sleep), NERVE COMPRESSION (patient was told maybe had a pinched nerve and that maybe came from neck) and PAIN IN EXTREMITY (get unbelievably pain in his arm, crying howbad the pain was on his arm) had not resolved.            No concomitant medication information provided. Patient did not have any allergies. It was reported that the patient was very healthy. It was reported that, following vaccination with the second booster the patient had severe pain on the 27 or 28-Jun-2022, on 05-Jul-2022 went to the emergency room, patient was told that maybe he had a pinched nerve in the emergency room, and that maybe came from his neck in a orthopedic walking clinic. The patient was given "all kind of medicines".  Patient took steroid shot and 2 more shots as treatment.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (sore injection arm) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection arm). At the time of the report, VACCINATION SITE PAIN (sore injection arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: received a Moderna booster dose 1 day later since it was opened; re-vaccinated with booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a Moderna booster dose 1 day later since it was opened) and EXTRA DOSE ADMINISTERED (re-vaccinated with booster) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a Moderna booster dose 1 day later since it was opened) and EXTRA DOSE ADMINISTERED (re-vaccinated with booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a Moderna booster dose 1 day later since it was opened) and EXTRA DOSE ADMINISTERED (re-vaccinated with booster) outcome was unknown.            No concomitant medications reported. No treatment reported   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (realized it was her second dose not booster/second Moderna dose administered on 06Jul2022 Lot#054A22A half dose) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 06-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (realized it was her second dose not booster/second Moderna dose administered on 06Jul2022 Lot#054A22A half dose). At the time of the report, ACCIDENTAL UNDERDOSE (realized it was her second dose not booster/second Moderna dose administered on 06Jul2022 Lot#054A22A half dose) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment drugs were reported. It was reported that caller declined providing any patient information at that time. Caller's first dose was Moderna as well so they did not mix. Nurse at local health department reports there was a client yesterday that received a half dose Moderna vaccine because they were informed it was their second booster dose.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophageal disorder
Clinical narrative: ended up in ICU due to her esophagus; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL DISORDER (ended up in ICU due to her esophagus) in a 35-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced OESOPHAGEAL DISORDER (ended up in ICU due to her esophagus) (seriousness criterion hospitalization). At the time of the report, OESOPHAGEAL DISORDER (ended up in ICU due to her esophagus) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment medication details reported. It was reported that patient had the first dose of Moderna in Feb2022 but got seriously sick and ended up in ICU due to her esophagus which was mentioned unrelated to the covid19 vaccine. Company Comment:  This is a spontaneous case concerning a 35-year-old female patient with no medical history reported, who experienced the unexpected serious event of Oesophageal disorder, which led to hospitalization, on the same year after receiving the first dose of mRNA-1273 vaccine. Patient also received an expired mRNA-1273 vaccine as second dose, approximately 4 months after the first mRNA-1273 vaccination. It was reported that the patient got seriously sick and was admitted in the ICU due to unspecified disorder of the esophagus. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-602866 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 35-year-old female patient with no medical history reported, who experienced the unexpected serious event of Oesophageal disorder, which led to hospitalization, on the same year after receiving the first dose of mRNA-1273 vaccine. Patient also received an expired mRNA-1273 vaccine as second dose, approximately 4 months after the first mRNA-1273 vaccination. It was reported that the patient got seriously sick and was admitted in the ICU due to unspecified disorder of the esophagus. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: they are unsure if he got a dose; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (they are unsure if he got a dose) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jul-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (they are unsure if he got a dose). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (they are unsure if he got a dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Retired pharmacist stated that her 2 year old grandson was taken by his mother to a clinic for his 1st dose of the Moderna Covid-19 Vaccine in his right leg.  As they were getting in their car about to leave that clinic, someone from the clinic stopped them & told them they are unsure if he got a dose.  Caller is unsure what made them think that.  They did say that they counted the doses that were given from the vial & it appears that the correct number of doses were given from it.  Caller says that he hasn't had any soreness in his right leg but  that is not a good indication of whether or not he got the dose.  Caller notes that his pediatrician wasn't involved with the dose administration & that we would want to speak to the vaccination facility instead.  Caller states that her daughter had spoke with the Chief Medical Officer of the vaccination facility who said they may want to consider a blood test to determine if the dose was given.  No treatment medication information provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 08 JUL 2022 after expiration date on 05 JUL 2022; Received expired first booster dose  beyond manufacturer date of expiry; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose  beyond manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 08 JUL 2022 after expiration date on 05 JUL 2022) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose  beyond manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 08 JUL 2022 after expiration date on 05 JUL 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose  beyond manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 08 JUL 2022 after expiration date on 05 JUL 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Patient received first booster dose of Moderna COVID-19 vaccine about 2 PM. The manufacturer expiration Date reported as 05 JUL 2022. Number of doses/vials reported was 1 dose / 1 Vial.   The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 08 JUL 2022 9 AM.  No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had covid two weeks ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had covid two weeks ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In September 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced COVID-19 (Had covid two weeks ago). At the time of the report, COVID-19 (Had covid two weeks ago) outcome was unknown. Concomitant drugs were not reported. Treatment medications were not provided.  Company Comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred approximately 9 months after the second dose of mRNA-1273 vaccine administration. No treatment medication were reported. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred approximately 9 months after the second dose of mRNA-1273 vaccine administration. No treatment medication were reported. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was opened today and had has been in the fridge unpunctured.; an expired dose of the Moderna COVID-19 vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (The vaccine was opened today and had has been in the fridge unpunctured.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 vaccine was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was opened today and had has been in the fridge unpunctured.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (The vaccine was opened today and had has been in the fridge unpunctured.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The number of doses per vial was1 dose from 1 vial administered. Vial was open today and it was brand new. The vial was initially stored in the refrigerator on 24 May 2022 The vial did not undergo any temperature excursions. No treatment reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: "knocked her on her butt for a couple of hours"/"Knocked her out"/. "Patient laid on the couch.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL ("knocked her on her butt for a couple of hours"/"Knocked her out"/. "Patient laid on the couch.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20 A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced FEELING ABNORMAL ("knocked her on her butt for a couple of hours"/"Knocked her out"/. "Patient laid on the couch.). At the time of the report, FEELING ABNORMAL ("knocked her on her butt for a couple of hours"/"Knocked her out"/. "Patient laid on the couch.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported.  The patient did not have any immediate side effects from her second dose however the patient noticed that she lost her sense of taste of smell about a month after receiving her second dose. The patient was told that the loss of smell and taste was related to the Moderna Covid-19 vaccine. The patient said that she has seen advertisements  from Doctors who offer to get patients sense of taste or smell back after taking a Covid-19 vaccine. The patient said that this was too expensive for her to do though. On 19NOV2021 the patient received her first Moderna booster dose. Lot number was 013F21A. Expiration date was not known. Patient received the vaccine in her left arm and the patient reports no adverse reactions or side effects. No treatment medication reported. This case was linked to MOD-2022-604647 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: missed her period; This spontaneous case was reported by an other health care professional and describes the occurrence of AMENORRHOEA (missed her period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (missed her period). At the time of the report, AMENORRHOEA (missed her period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient reported that she is not sexually active and lab tests confirmed she is not pregnant. She know this is a potential side effect of the vaccine. Treatment information was not provided.   This case was linked to MOD-2022-604578 (Patient Link).