chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Booster doses with a plus 30 days refrigerated stored vial; Expired Booster Doses Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) and PRODUCT STORAGE ERROR (Booster doses with a plus 30 days refrigerated stored vial) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2022 at 12:44 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Feb-2022 at 12:44 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Booster doses with a plus 30 days refrigerated stored vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) and PRODUCT STORAGE ERROR (Booster doses with a plus 30 days refrigerated stored vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Reporter stated that on 21-Jan-2022 at 06:00 AM vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2022: Reporter information was updated On 28-Feb-2022: Follow-up received contains suspect product time, route of administration and dose volume and additional event of Product storage error were updated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Macule, Neuralgia, Polymerase chain reaction, Rash
Clinical narrative: Rash started 2 days after vaccination; Typical sore arm but couldn't use arm for 2 days; Fatigue; Nerve pain from elbow to pinky; Macules on arm, Bier spots; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain from elbow to pinky), MACULE (Macules on arm, Bier spots), RASH (Rash started 2 days after vaccination), VACCINATION SITE PAIN (Typical sore arm but couldn't use arm for 2 days) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination.     The patient's past medical history included Insomnia. Concurrent medical conditions included Fatigue and Penicillin allergy.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced NEURALGIA (Nerve pain from elbow to pinky), MACULE (Macules on arm, Bier spots), VACCINATION SITE PAIN (Typical sore arm but couldn't use arm for 2 days) and FATIGUE (Fatigue). On 20-Jul-2021, the patient experienced RASH (Rash started 2 days after vaccination). The patient was treated with PROPRANOLOL for Postural orthostatic tachycardia syndrome and Tachycardia, at a dose of 1 dosage form. In August 2021, RASH (Rash started 2 days after vaccination) had resolved. At the time of the report, NEURALGIA (Nerve pain from elbow to pinky), MACULE (Macules on arm, Bier spots), VACCINATION SITE PAIN (Typical sore arm but couldn't use arm for 2 days) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Polymerase chain reaction: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had rash started about 2 days after the 1st dose and went away 3 weeks later, typical sore arm  but couldn't use the arm for 2 days, Fatigue, Nerve pain from the elbow to the pinky, macules on arm not raised, bier spots.   Patient has seen a great number of specialists but the lab work is normal. Patient also got a T cell test, nucleocapsid test done.   This case was linked to MOD-2022-494528 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Rash started 2 days after vaccination; Typical sore arm but couldn't use arm for 2 days; Fatigue; Nerve pain from elbow to pinky; Macules on arm, Bier spots; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain from elbow to pinky), MACULE (Macules on arm, Bier spots), RASH (Rash started 2 days after vaccination), VACCINATION SITE PAIN (Typical sore arm but couldn't use arm for 2 days) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination.     The patient's past medical history included Insomnia. Concurrent medical conditions included Fatigue and Penicillin allergy.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced NEURALGIA (Nerve pain from elbow to pinky), MACULE (Macules on arm, Bier spots), VACCINATION SITE PAIN (Typical sore arm but couldn't use arm for 2 days) and FATIGUE (Fatigue). On 20-Jul-2021, the patient experienced RASH (Rash started 2 days after vaccination). The patient was treated with PROPRANOLOL for Postural orthostatic tachycardia syndrome and Tachycardia, at a dose of 1 dosage form. In August 2021, RASH (Rash started 2 days after vaccination) had resolved. At the time of the report, NEURALGIA (Nerve pain from elbow to pinky), MACULE (Macules on arm, Bier spots), VACCINATION SITE PAIN (Typical sore arm but couldn't use arm for 2 days) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Polymerase chain reaction: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had rash started about 2 days after the 1st dose and went away 3 weeks later, typical sore arm  but couldn't use the arm for 2 days, Fatigue, Nerve pain from the elbow to the pinky, macules on arm not raised, bier spots.   Patient has seen a great number of specialists but the lab work is normal. Patient also got a T cell test, nucleocapsid test done.   This case was linked to MOD-2022-494528 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Patient thought he had bronchitis, went to ER but it was a heart attack, Patient passed away; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Patient thought he had bronchitis, went to ER but it was a heart attack, Patient passed away) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Patient thought he had bronchitis, went to ER but it was a heart attack, Patient passed away) (seriousness criteria death and medically significant). The patient died on 06-May-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  The AE caused the patient to seek medical care included ER (emergency room) visit.  No treatment information was provided.  Company comment: This is a spontaneous case concerning a 64 year-old, male patient with no reported medical history, who experienced the Fatal serious (medically significant) unexpected, AESI of Myocardial infarction. The event occurred after the second dose of mRNA-1273 vaccine, vaccination exact date not provided. The patient died 6 days after the onset of the event. It is unknown whether an autopsy was performed. The cause of death was reported as Myocardial infarction. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received contains no new information. On 24-Feb-2022: Follow-up received contains no new information.; Sender's Comments: This is a spontaneous case concerning a 64 year-old, male patient with no reported medical history, who experienced the Fatal serious (medically significant) unexpected, AESI of Myocardial infarction. The event occurred after the second dose of mRNA-1273 vaccine, vaccination exact date not provided. The patient died 6 days after the onset of the event. It is unknown whether an autopsy was performed. The cause of death was reported as Myocardial infarction. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Heart attack
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia, Magnetic resonance imaging, Paraesthesia
Clinical narrative: hair started falling out; started to have memory problems; After the second dose the patient noticed that the burning in her right foot and leg continued; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (After the second dose the patient noticed that the burning in her right foot and leg continued), ALOPECIA (hair started falling out) and MEMORY IMPAIRMENT (started to have memory problems) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014FZ21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced BURNING SENSATION (After the second dose the patient noticed that the burning in her right foot and leg continued) (seriousness criterion medically significant). In November 2021, the patient experienced MEMORY IMPAIRMENT (started to have memory problems) (seriousness criterion medically significant). In January 2022, the patient experienced ALOPECIA (hair started falling out) (seriousness criterion medically significant). At the time of the report, BURNING SENSATION (After the second dose the patient noticed that the burning in her right foot and leg continued) had not resolved and ALOPECIA (hair started falling out) and MEMORY IMPAIRMENT (started to have memory problems) outcome was unknown.            Concomitant medication was not reported.  The patient noticed that her hair was falling out starting a month. The patient noticed this about her hair in late January 2022. The patient stated she was kind of ol. The patient started to have memory problems in November 2021.  Treatment medication was not reported.   This case was linked to MOD-2022-494745 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no medical history reported, experienced the unexpected serious events Burning sensation, on same day, Memory impairment two months after and Alopecia four months after the second dose of mRNA-1273. It was reported that the patient developed, burning in her right foot and leg, memory problems and hair started falling off. The patient had burning sensation of foot after first dose which indicates a positive rechallenge. Elderly age of the patient and previous use of Gabapentin could be confounders for the events Memory impairment and Alopecia. At the time of reporting, the event Burning sensation had not resolved and outcome of Memory loss and Alopecia was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Burning sensation, Memory impairment
Clinical narrative: hair started falling out; started to have memory problems; After the second dose the patient noticed that the burning in her right foot and leg continued; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (After the second dose the patient noticed that the burning in her right foot and leg continued), ALOPECIA (hair started falling out) and MEMORY IMPAIRMENT (started to have memory problems) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014FZ21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced BURNING SENSATION (After the second dose the patient noticed that the burning in her right foot and leg continued) (seriousness criterion medically significant). In November 2021, the patient experienced MEMORY IMPAIRMENT (started to have memory problems) (seriousness criterion medically significant). In January 2022, the patient experienced ALOPECIA (hair started falling out) (seriousness criterion medically significant). At the time of the report, BURNING SENSATION (After the second dose the patient noticed that the burning in her right foot and leg continued) had not resolved and ALOPECIA (hair started falling out) and MEMORY IMPAIRMENT (started to have memory problems) outcome was unknown.            Concomitant medication was not reported.  The patient noticed that her hair was falling out starting a month. The patient noticed this about her hair in late January 2022. The patient stated she was kind of ol. The patient started to have memory problems in November 2021.  Treatment medication was not reported.   This case was linked to MOD-2022-494745 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no medical history reported, experienced the unexpected serious events Burning sensation, on same day, Memory impairment two months after and Alopecia four months after the second dose of mRNA-1273. It was reported that the patient developed, burning in her right foot and leg, memory problems and hair started falling off. The patient had burning sensation of foot after first dose which indicates a positive rechallenge. Elderly age of the patient and previous use of Gabapentin could be confounders for the events Memory impairment and Alopecia. At the time of reporting, the event Burning sensation had not resolved and outcome of Memory loss and Alopecia was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Has patient ever had COVID  test or diagnosis If yes, provide date. 7 to 15 days before her second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Has patient ever had COVID  test or diagnosis If yes, provide date. 7 to 15 days before her second dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (Has patient ever had COVID  test or diagnosis If yes, provide date. 7 to 15 days before her second dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Has patient ever had COVID  test or diagnosis If yes, provide date. 7 to 15 days before her second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided by the reporter. Company comment: This spontaneous case concerns a 41-year-old, female patient with no medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (Has patient ever had COVID test or diagnosis If yes, provide date. 7 to 15 days before her second dose) which occurred on unknown date in jan-2022 after the first dose of mRNA-1273 vaccine received on 30-dec-2021.SARS-CoV-2 test was positive as on unknown date.It was reported that patient received second dose on 27-jan-2022 and developed tachycardia, shaking in the body, legs, arms, teeth and face which last 5-6 minutes and happened twice on the 8-Feb-2022 and 23-Feb-2022. Current ongoing pandemic remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-494916, MOD-2022-494980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received:  No new Information.; Sender's Comments: This spontaneous case concerns a 41-year-old, female patient with no medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (Has patient ever had COVID test or diagnosis If yes, provide date. 7 to 15 days before her second dose) which occurred on unknown date in jan-2022 after the first dose of mRNA-1273 vaccine received on 30-dec-2021.SARS-CoV-2 test was positive as on unknown date.It was reported that patient received second dose on 27-jan-2022 and developed tachycardia, shaking in the body, legs, arms, teeth and face which last 5-6 minutes and happened twice on the 8-Feb-2022 and 23-Feb-2022. Current ongoing pandemic remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses administered after 30-day use by date; Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022). On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported. On 17 DEC 2021 vial was initially stored in the refrigerator.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.  The Moderna vaccine BUD was 16-Jan-2022.  Reporter confirmed that 23 patients received shots after the 30-day use by date. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Number of doses/vials: 23 doses. On 17-Dec-2021, the vial was initially stored in the refrigerator. The vial didn't undergo any temperature excursions.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient had covid(omicron),her symptoms were mild; Booster dose: 12nov2021, She had Covid on 8jan2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had covid(omicron),her symptoms were mild) and DRUG INEFFECTIVE (Booster dose: 12nov2021, She had Covid on 8jan2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 062G20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced COVID-19 (Patient had covid(omicron),her symptoms were mild) and DRUG INEFFECTIVE (Booster dose: 12nov2021, She had Covid on 8jan2022). At the time of the report, COVID-19 (Patient had covid(omicron),her symptoms were mild) and DRUG INEFFECTIVE (Booster dose: 12nov2021, She had Covid on 8jan2022) outcome was unknown.            No concomitant medication details were reported. Patient did not get tested for the variant specifically No treatment information details were reported.  Company comment: This spontaneous case concerns a 69-year-old female patient with no relevant medical history, who experienced unexpected non serious event (AESI) of COVID-19 and Drug ineffective which occurred 1 months 28 days after the third dose of properly scheduled first and second dose of mRNA-1273 vaccine. Lack of efficacy is also noted in this case as it satisfies the criteria of LOE (LOE noticed after 15 days after the second dose and the interval between the two doses is around 25-35 days with Moderna vaccine). Current ongoing pandemic remains as a confounder. The benefit-risk relationship of drug is not affected by this report..; Sender's Comments: This spontaneous case concerns a 69-year-old female patient with no relevant medical history, who experienced unexpected non serious event (AESI) of COVID-19 and Drug ineffective which occurred 1 months 28 days after the third dose of properly scheduled first and second dose of mRNA-1273 vaccine. Lack of efficacy is also noted in this case as it satisfies the criteria of LOE (LOE noticed after 15 days after the second dose and the interval between the two doses is around 25-35 days with Moderna vaccine). Current ongoing pandemic remains as a confounder. The benefit-risk relationship of drug is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired - 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 7:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Jan-2022 at 7:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 16-Dec-2021 Moderna vaccine was pulled from freezer. Beyond use date (BUD) of 15-Jan-2022 was printed in red and taped to the top of the boxes. The patient was notified of the error and patient denied adverse effects.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received. IRD changed (25-feb-2022 to 24-Feb-2022).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Basedow's disease, COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Covid; Graves' disease; This spontaneous case was reported by a consumer and describes the occurrence of BASEDOW'S DISEASE (Graves' disease) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart rate high (elevated heart rate) in October 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BASEDOW'S DISEASE (Graves' disease) (seriousness criterion medically significant). On 08-Jan-2022, the patient experienced COVID-19 (Covid). At the time of the report, BASEDOW'S DISEASE (Graves' disease) outcome was unknown and COVID-19 (Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2022, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  Patient received his first dose of the Moderna vaccine and does not have specific dates or lot numbers It was reported that prior to getting his second dose patient was diagnosed with Grave's disease and patient's mother reported that no healthcare professional said it was related to the vaccine because it showed he had elevated heart rate dating back to oct-2020 which is a symptom of Grave's disease. He has not received his booster.  No treatment details were reported.  Company comment-This spontaneous case concerns a 27-year old, male patient with relevant medical history of  increased heart rate, who experienced the unexpected serious (medically significant) event of Basedow's disease which occurred at an unknown interval after receiving the first dose of mRNA-1273 vaccine. He also experienced unexpected non-serious AESI event of Covid-19 at an unknown interval and recovered from the same. The outcome of the event Basedow's disease was not known at the time of this report. Medical history of elevated heart rate could be a confounder to the event Basedow's disease.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report..   This case was linked to MOD-2022-495556 (Patient Link).; Sender's Comments: This spontaneous case concerns a 27-year old, male patient with relevant medical history of  increased heart rate, who experienced the unexpected serious (medically significant) event of Basedow's disease which occurred at an unknown interval after receiving the first dose of mRNA-1273 vaccine. He also experienced unexpected non-serious AESI event of Covid-19 at an unknown interval and recovered from the same. The outcome of the event Basedow's disease was not known at the time of this report. Medical history of elevated heart rate could be a confounder to the event Basedow's disease.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report..
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: had COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had COVID) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease ( data logger showed elevated heart rate back to oct2020 which is symptom of Grave's disease.) since 2021.   In April 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. On 08-Jan-2022, the patient experienced COVID-19 (had COVID). At the time of the report, COVID-19 (had COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2022, SARS-CoV-2 antibody test: positive (Positive) positive.         No concomitant medications were reported. Prior to the second dose of Moderna vaccine patient was diagnosed with Grave's disease and patient's mother reported that no healthcare professional said it was related to the vaccine because patient's data logger showed he had elevated heart rate dating back to OCT-2020 which is a symptom of Grave's disease. He has not received his booster. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 27-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of Covid-19 which occurred unspecified days after receiving second dose of mRNA-1273 vaccine administration. SARS-CoV-2 antibody test: positive as on 08-Jan-2022. It was reported that prior to the second dose of Moderna vaccine patient was diagnosed with Grave's disease. Ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-495548 (Patient Link).; Sender's Comments: This spontaneous case concerns a 27-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of Covid-19 which occurred unspecified days after receiving second dose of mRNA-1273 vaccine administration. SARS-CoV-2 antibody test: positive as on 08-Jan-2022. It was reported that prior to the second dose of Moderna vaccine patient was diagnosed with Grave's disease. Ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired - 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 10:41 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  Reporter stated that Moderna vaccine pulled from freezer 16 Dec 2021, BUD date of 15 Jan 2022 printed in red and taped to the top of the boxes. On 26 Jan 2022, staff brought it to attention that it was still in the fridge and expired and 5 doses had been given. On 31 Jan 2022, responded that revaccination was not required.  Patient denies any adverse effects.  No treatment information details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up information includes - IRD changed(25-feb-2022 to 24-Feb-2022).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body aches) in a 40-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. On an unknown date, the patient experienced MYALGIA (Body aches) (seriousness criterion hospitalization). At the time of the report, MYALGIA (Body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  HCP was calling regarding a patient who wants to receive Moderna booster vaccine but had experienced a severe allergic reaction a month ago to monoclonal antibodies.  Patient experienced minor symptoms after first and second dose of Moderna, such as body aches. Patient did not experience a severe allergic reaction to Moderna vaccines.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment drug was received monoclonal antibodies.  Company comment:  This spontaneous case concerns a 40-year-old female with no medical history who experienced the serious (hospitalization) unexpected event of myalgia at an unknown time after the first and second dose of mRNA-1273 10 minutes after they received monoclonal antibodies for COVID-19 infection. Testing and treatment are unknown. The outcome is recovered. The risk-benefit relationship of mRNA-1273 vaccine is not affected by this report. The use of monoclonal antibodies 10 minutes before the event occurred requires and OML. As the patient had COVID-19 infection after the second dose of mRNA-1273 and may have met criteria for LOE and this should be investigated.   This case was linked to MOD-2022-495760 (Patient Link).; Sender's Comments: This spontaneous case concerns a 40-year-old female with no medical history who experienced the serious (hospitalization) unexpected event of myalgia at an unknown time after the first and second dose of mRNA-1273 10 minutes after they received monoclonal antibodies for COVID-19 infection. Testing and treatment are unknown. The outcome is recovered. The risk-benefit relationship of mRNA-1273 vaccine is not affected by this report. The use of monoclonal antibodies 10 minutes before the event occurred requires and OML. As the patient had COVID-19 infection after the second dose of mRNA-1273 and may have met criteria for LOE and this should be investigated.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Terminal state
Clinical narrative: possible death, might not be able to make it; This spontaneous case was reported by a consumer and describes the occurrence of TERMINAL STATE (possible death, might not be able to make it) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TERMINAL STATE (possible death, might not be able to make it) (seriousness criterion medically significant). At the time of the report, TERMINAL STATE (possible death, might not be able to make it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   The patient might not be able to make it and the doctors did not know the reason. No treatment information was provided.  Company comment:  Very little information is available as the case was reported by a "friend" who gave no information except age and event as stated with no details and refused follow-up. This spontaneous case concerns a 24-year-old of unknown gender with no medical history reported who experienced the serious (medically significant) event of LLT/might not be able to make it, PT/terminal state at an unknown time after an unknown dose of mRNA-1273. Testing, treatment and outcome not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Non Significant follow up(No new information received); Sender's Comments: Very little information is available as the case was reported by a "friend" who gave no information except age and event as stated with no details and refused follow-up. This spontaneous case concerns a 24-year-old of unknown gender with no medical history reported who experienced the serious (medically significant) event of LLT/might not be able to make it, PT/terminal state at an unknown time after an unknown dose of mRNA-1273. Testing, treatment and outcome not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Maternal exposure during pregnancy
Clinical narrative: not feeling good; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MALAISE (not feeling good) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MALAISE (not feeling good) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MALAISE (not feeling good) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that her friend received vaccine and stated she was not feeling good.  Concomitant medication and treatment information was not reported by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received on 24-Feb-2022 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No Treatment Medication reported.  Reporter mentioned her best friend died. Caller mentioned patient called before. Company comment This spontaneous fatal case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious fatal event of DEATH. Onset date of the events were not provided nor vaccination date or schedule; hence, latency cannot be assessed. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Reporter mentioned her best friend died. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received on 25 Feb 2022 contains No New Information.; Sender's Comments: This spontaneous fatal case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious fatal event of DEATH. Onset date of the events were not provided nor vaccination date or schedule; hence, latency cannot be assessed. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Reporter mentioned her best friend died. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Neuropathy peripheral
Clinical narrative: possible side effects regarding neuropathy; possible muscle fasciculation; This spontaneous case was reported by a health care professional and describes the occurrence of NEUROPATHY PERIPHERAL (possible side effects regarding neuropathy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced NEUROPATHY PERIPHERAL (possible side effects regarding neuropathy) (seriousness criterion medically significant) and MUSCLE CONTRACTIONS INVOLUNTARY (possible muscle fasciculation). At the time of the report, NEUROPATHY PERIPHERAL (possible side effects regarding neuropathy) and MUSCLE CONTRACTIONS INVOLUNTARY (possible muscle fasciculation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported  Company comment: This spontaneous case concerns a male patient of an unknown age with no a medical history reported, who experienced the serious (medically significant)  unexpected event of Neuropathy peripheral in association with a dose of mRNA- 1273 vaccine (unknown dose number). Temporal association cannot be assessed due to lack of information on the vaccination date. Involuntary muscle contractions were also reported. No further information is available. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no a medical history reported, who experienced the serious (medically significant)  unexpected event of Neuropathy peripheral in association with a dose of mRNA- 1273 vaccine (unknown dose number). Temporal association cannot be assessed due to lack of information on the vaccination date. Involuntary muscle contractions were also reported. No further information is available. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 expired- Doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that point) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022 at 9:23 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  Moderna vaccine was pulled from freezer on 16/12/2021, BUD date of 15/01/2022, printed in red and taped to the box of the boxes.  On 26/1/2022, staff brought it to attention that it was still in the fridge and expired- 5 doses had been given at that point.  On 27/01/2022, remaining county sites checked. All other clinics were found to have same error of noticing the BUD date. Moderna contacted and report filed.  BUD date added to the daily COVID- usage and wastage report and staff reeducation was provided.  On 31.1.2022, Moderna responded, suggested to be revaccination as not required, but  asked to forward VAERS form.
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion
Clinical narrative: water around her heart; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (water around her heart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDIAL EFFUSION (water around her heart) (seriousness criterion medically significant). At the time of the report, PERICARDIAL EFFUSION (water around her heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.  Company comment: This spontaneous case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected serious (medically significant) event of Pericardial effusion unknown days after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Non Significant follow up received which contains no new information; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected serious (medically significant) event of Pericardial effusion unknown days after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.