chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No medical history was reported. It was unknown if patient was diagnosed with COVID-19 test positive and it was unknown if patient had acute and chronic illness.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vaccine was administrated after the beyond use date  and after the thaw process. The patient had no adverse reactions and no reports of any reactions after the administration of the vaccine was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) 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) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 36 years and 07 months. No concomitant medications were reported. On 10-Jun-2022, the vaccine facility staff was notified of an audit that was done and they were made aware of vaccines that were administered beyond use date after the thaw process. Patient had not reported any adverse reactions after the administration of the vaccine. No treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; Vaccine underdose(covid vaccine number-2nd / dose volume:0.25 ml); This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25 ml)) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25 ml)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25 ml)) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 29 years and 11 months.  No concomitant medications were reported.  On 10-Jun-2022, the vaccine facility staff was notified of an audit that was done and they were made aware of vaccines that were administered beyond use date after the thaw process.  There was no adverse reaction noted or reported  regarding the administrations.Patient got Moderna with vaccine Ndc code 80777-0273-99.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:Master case
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 27-May-2022; Administered vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 27-May-2022) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     No known allergies reported, Patient was not diagnosed with or tested positive for COVID-19. Patient not had acute illnesses at the time of vaccination and up to one month before. Patient not had Chronic or long standing health conditions.     On 27-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 27-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 27-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Reported that patient was not taking prescriptions, over the counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  Time of administration for first dose reported as 12:00 am.  Reported that administered vaccine after the BUD from 08-Mar-2022 to 01-Jun-2022. The vial was initially stored in refrigerator on 08-Mar-2022. The vial did not undergo the temperature excursion. The patient had not reported symptoms. No additional doses, medications, or treatments had been administered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; Vaccine underdose(covid vaccine number-2nd / dose volume:0.25); This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25)) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25)) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that no adverse events had occurred after administration of vaccine to the patient. No treatment medications were reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) 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) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient age was reported as 20 years 1 months.  No concomitant medications were reported. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Vaccine Ndc Code was reported as 80777-0273-99. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment information was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccines beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown whether the patient was diagnosed or tested positive for covid-19.  Acute illness at the time of vaccination and up to one month before was not known.  Chronic and long-standing health conditions were unknown.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported has 49 years 8 months.  The patient got Moderna with vaccine Ndc code 80777027399.  The medical notified of an audit that was done which made aware that some vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Concomitant drugs were not reported.  Treatment details were not given.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administrated beyond use date after the thaw process.; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administrated beyond use date after the thaw process.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown  if patient had ever been diagnosed with/ tested positive for COVID-19.  It was unknown if patient had chronic or long-standing health conditions  It was unknown if patient had acute illnesses at the time of vaccination and up to one month before.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administrated beyond use date after the thaw process.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administrated beyond use date after the thaw process.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 36 years and 8 months.  No concomitant medication information was provided.  It was reported that the had no adverse reactions after the administration of the vaccines.  No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:MCN
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown if patient had been diagnosed with or tested positive for COVID-19, or if patient had chronic or long lasting health conditions. It was unknown if patient had any acute illness at the time of vaccination and up to one month before.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna vaccine and the Ndc code was reported. Patient had reported no adverse reactions after the administration of vaccine. Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; Vaccine number 2nd and dose volume 0.25; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 24 years and 04 months. No concomitant medications were reported. On 10-Jun-2022, the vaccine facility staff was notified of an audit that was done and they were made aware of vaccines that were administered beyond use date after the thaw process. Patient had not reported any adverse reactions after the administration of the vaccine. No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored on 08 Mar 2022 in refrigerator and vaccine administered on 16 May 2022.; Vaccine were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Vial was initially stored on 08 Mar 2022 in refrigerator and vaccine administered on 16 May 2022.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-May-2022 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored on 08 Mar 2022 in refrigerator and vaccine administered on 16 May 2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Vial was initially stored on 08 Mar 2022 in refrigerator and vaccine administered on 16 May 2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Six (6) vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022. The vials did not undergo any temperature excursions. The patient had not reported symptoms.   Treatment details was not reported by the reporter.  As per Moderna Lot analysis, Doses administered on 06May 2022,16 May 2022,20 May 2022,24May 2022,27May 2022,01June 2022:Moderna cannot guarantee patient received full protection against the COVID-19 Virus.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Erythema, Fatigue
Clinical narrative: Had covid in November,2021; Had covid in November,2021; This spontaneous case was reported by a patient and describes the occurrence of DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A, 030M20A and 939903) for COVID-19 vaccination.     The patient had no allergies.  The patient's past medical history included Flu (had flu before the 1st dose of moderna vaccine.). Concomitant products included ATENOLOL for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.         Company comment: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected of COVID-19 (among other non-serious events), 8 months after the second dose of mRNA-1273 vaccine. An additional event of drug ineffective was also reported. Interval between first and second dose was of 28 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-594655; Sender's Comments: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected of COVID-19 (among other non-serious events), 8 months after the second dose of mRNA-1273 vaccine. An additional event of drug ineffective was also reported. Interval between first and second dose was of 28 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain, Somnolence, Vaccination site lymphadenopathy
Clinical narrative: Had covid in November,2021; Had covid in November,2021; This spontaneous case was reported by a patient and describes the occurrence of DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A, 030M20A and 939903) for COVID-19 vaccination.     The patient had no allergies.  The patient's past medical history included Flu (had flu before the 1st dose of moderna vaccine.). Concomitant products included ATENOLOL for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.         Company comment: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected of COVID-19 (among other non-serious events), 8 months after the second dose of mRNA-1273 vaccine. An additional event of drug ineffective was also reported. Interval between first and second dose was of 28 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-594655; Sender's Comments: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected of COVID-19 (among other non-serious events), 8 months after the second dose of mRNA-1273 vaccine. An additional event of drug ineffective was also reported. Interval between first and second dose was of 28 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Had covid in November,2021; Had covid in November,2021; This spontaneous case was reported by a patient and describes the occurrence of DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A, 030M20A and 939903) for COVID-19 vaccination.     The patient had no allergies.  The patient's past medical history included Flu (had flu before the 1st dose of moderna vaccine.). Concomitant products included ATENOLOL for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.         Company comment: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected of COVID-19 (among other non-serious events), 8 months after the second dose of mRNA-1273 vaccine. An additional event of drug ineffective was also reported. Interval between first and second dose was of 28 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-594655; Sender's Comments: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected of COVID-19 (among other non-serious events), 8 months after the second dose of mRNA-1273 vaccine. An additional event of drug ineffective was also reported. Interval between first and second dose was of 28 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had covid in November,2021; Had covid in November,2021; This spontaneous case was reported by a patient and describes the occurrence of DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A, 030M20A and 939903) for COVID-19 vaccination.     The patient had no allergies.  The patient's past medical history included Flu (had flu before the 1st dose of moderna vaccine.). Concomitant products included ATENOLOL for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DRUG INEFFECTIVE (Had covid in November,2021) and COVID-19 (Had covid in November,2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.         Company comment: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected of COVID-19 (among other non-serious events), 8 months after the second dose of mRNA-1273 vaccine. An additional event of drug ineffective was also reported. Interval between first and second dose was of 28 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-594655; Sender's Comments: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected of COVID-19 (among other non-serious events), 8 months after the second dose of mRNA-1273 vaccine. An additional event of drug ineffective was also reported. Interval between first and second dose was of 28 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: The caller said her eye doctor had myocarditis after the modern vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (The caller said her eye doctor had myocarditis after the modern vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (The caller said her eye doctor had myocarditis after the modern vaccine.) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (The caller said her eye doctor had myocarditis after the modern vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after a dose of mRNA-1273 vaccine. Consumer reported her eye doctor had myocarditis after Moderna vaccine. 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-2022-594678, MOD-2022-594696 (Patient Link).; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after a dose of mRNA-1273 vaccine. Consumer reported her eye doctor had myocarditis after Moderna vaccine. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: product storage error; Dose administered more than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (product storage error) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022 at 7:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (product storage error) outcome 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. It was reported that patient had taken second booster dose. The number of doses per vial was 2 doses which was booster doses. On 01June 2022 the vial was initially stored in the refrigerator. On 06June2022 at 10:00AM the vial was first punctured. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions Total amount of time the vial was exposed to room temperature range was for more than 24 hours.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 06-JUN-2022, post punctured stored at fridge and administered on 24-JUN-2022; Dose administered >12(hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12(hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 06-JUN-2022, post punctured stored at fridge and administered on 24-JUN-2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022 at 7:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12(US hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 06-JUN-2022, post punctured stored at fridge and administered on 24-JUN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12(hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 06-JUN-2022, post punctured stored at fridge and administered on 24-JUN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received second booster dose of Moderna COVID-19 vaccine. No concomitant information was reported by the reporter. On 01-JUN-2022 vial was initially stored in refrigerator, on 06-JUN-2022 at 10:00AM  vial was first punctured and on 24-JUN-2022 at 7:00 A vial was administered to patient .It is also reported that vial after punctured stored in fridge and the vial doesn't go under temperature excursions. No treatment information was provided by the reporter.   This case was linked to MOD-2022-594660.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: I feel like I have a cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (I feel like I have a cold) in a  patient of an unknown age and gender 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 an unknown date, the patient experienced NASOPHARYNGITIS (I feel like I have a cold). At the time of the report, NASOPHARYNGITIS (I feel like I have a cold) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient had a stroke 2 days after taking the Moderna vaccine. No treatment medications were reported.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected serious (medically significant) AESI of Cerebrovascular accident which occurred 2 days after a dose of mRNA-1273 Vaccine in COVID 19 vaccination series. Details regarding medical history, treatment, clinical course, outcome are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event serious assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected serious (medically significant) AESI of Cerebrovascular accident which occurred 2 days after a dose of mRNA-1273 Vaccine in COVID 19 vaccination series. Details regarding medical history, treatment, clinical course, outcome are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event serious assessed as per medical judgement.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (brother had a heart attack after getting the vaccine) in a male patient of an unknown age 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 an unknown date, the patient experienced MYOCARDIAL INFARCTION (brother had a heart attack after getting the vaccine) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (brother had a heart attack after getting the vaccine) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. Company Comment: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of myocardial infarction unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. It was reported that the patient experienced a heart attack after vaccination. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-594901 (Patient Link). Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of myocardial infarction unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. It was reported that the patient experienced a heart attack after vaccination. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: Heart enlarged; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIOMEGALY (Heart enlarged) in a female patient of an unknown age 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 an unknown date, the patient experienced CARDIOMEGALY (Heart enlarged). At the time of the report, CARDIOMEGALY (Heart enlarged) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-594678, MOD-2022-594659 (Patient Link).   Reporter did not allow further contact
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: I have had difficulty with my left arm ever since then; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I have had difficulty with my left arm ever since then) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced LIMB DISCOMFORT (I have had difficulty with my left arm ever since then). The patient was treated with CORTISONE at a dose of two cortisone shots and Physical therapy (Patient went through six weeks of physical therapy) for Limb discomfort. At the time of the report, LIMB DISCOMFORT (I have had difficulty with my left arm ever since then) had not resolved.            Concomitant medications were not reported. Patient had reported he took a Moderna booster shot in January and had difficulty with left arm ever since then. Patient was still going through a physical therapy.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Mom passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Mom passed away) 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. Death occurred on September 2021 The patient died in September 2021. 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.       Concomitant product use information was not provided by the reporter. Treatment information was not provided.   Company comment: This is a spontaneous case reported by the patient's son, concerning a female patient of unknown age with no reported medical history, who experienced the unexpected serious (death and medically significant) event of death. The event occurred after the unknown dose number of mRNA-1273 vaccine administration. The cause of death was not reported. It is unknown if autopsy was performed. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-594693 (Patient Link).; Sender's Comments: This is a spontaneous case reported by the patient's son, concerning a female patient of unknown age with no reported medical history, who experienced the unexpected serious (death and medically significant) event of death. The event occurred after the unknown dose number of mRNA-1273 vaccine administration. The cause of death was not reported. It is unknown if autopsy was performed. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022; Vaccine administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported as the vial was stored in refrigerator on 18-May-2022 and administered to patient past 30-day use by date or after manufacturer date of expiry.  The vial did not undergo any temperature excursion.  The reporter believed that lot numbers for previous doses of the patient was moderna, but was unsure.  No treatment medication were provided.