chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  The caller said that need to look in another system to determine if the patient's received the doses in the left or right arm and if this was their first, second or booster doses. This is a case of Expired Product Administered concerning a 67-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 67-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Relevant concomitant medications were not reported. Treatment information was not provided. This is a case of Expired Product Administered concerning a 43-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 43-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 11NOV2021); This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 11NOV2021)) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 11NOV2021)). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 11NOV2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  This is a case of Expired Product Administered concerning a 65-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 65-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      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.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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..
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 47 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter. No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients have received an expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that they had received the vaccine on 18-Oct-2021 and on the same day, the vial was stored in the refrigerator. The reporter did not realize that the vial was expired 07-Nov-2021. The reporter also reported that, it was unknown if this was the patient's first, second or booster doses. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients have received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients have received an expired vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients have received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patients have received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that they had received the vaccine on 18-Oct-2021 and on the same day, the vial was stored in the refrigerator. The reporter did not realize that the vial was expired 07-Nov-2021. The reporter also reported that, it was unknown if this was the patient's first, second or booster doses. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved.        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.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 17NOV2021); This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 17NOV2021)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 17NOV2021)). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 17NOV2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  Vaccine expiration date was mentioned as 07-NOV-2021.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No Treatment medications were provided  This is a case of Expired Product Administered concerning an 89-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The re-challenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning an 89-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: A bad sore throat so bad that he could not drink water; He started feeling unwell; Had a fever of 103degF; Still feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (A bad sore throat so bad that he could not drink water), VACCINATION COMPLICATION (He started feeling unwell), PYREXIA (Had a fever of 103degF) and FATIGUE (Still feeling tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Comirnaty (as primary series). Past adverse reactions to the above products included No adverse event with Pfizer Comirnaty.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (A bad sore throat so bad that he could not drink water), VACCINATION COMPLICATION (He started feeling unwell), PYREXIA (Had a fever of 103degF) and FATIGUE (Still feeling tired). At the time of the report, OROPHARYNGEAL PAIN (A bad sore throat so bad that he could not drink water), VACCINATION COMPLICATION (He started feeling unwell), PYREXIA (Had a fever of 103degF) and FATIGUE (Still feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103degF. On an unknown date, SARS-CoV-2 test: negative (Negative) PCR twice for COVID 19 but returned negative..         No Concomitant informations were reported. No Treatment informations were reported.  This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Oropharyngeal pain, Vaccination Complication and expected events of Pyrexia and Fatigue. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events Pyrexia and Fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Oropharyngeal pain, Vaccination Complication and expected events of Pyrexia and Fatigue. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events Pyrexia and Fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: A bad sore throat so bad that he could not drink water; He started feeling unwell; Had a fever of 103degF; Still feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (A bad sore throat so bad that he could not drink water), VACCINATION COMPLICATION (He started feeling unwell), PYREXIA (Had a fever of 103degF) and FATIGUE (Still feeling tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Comirnaty (as primary series). Past adverse reactions to the above products included No adverse event with Pfizer Comirnaty.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (A bad sore throat so bad that he could not drink water), VACCINATION COMPLICATION (He started feeling unwell), PYREXIA (Had a fever of 103degF) and FATIGUE (Still feeling tired). At the time of the report, OROPHARYNGEAL PAIN (A bad sore throat so bad that he could not drink water), VACCINATION COMPLICATION (He started feeling unwell), PYREXIA (Had a fever of 103degF) and FATIGUE (Still feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103degF. On an unknown date, SARS-CoV-2 test: negative (Negative) PCR twice for COVID 19 but returned negative..         No Concomitant informations were reported. No Treatment informations were reported.  This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Oropharyngeal pain, Vaccination Complication and expected events of Pyrexia and Fatigue. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events Pyrexia and Fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Oropharyngeal pain, Vaccination Complication and expected events of Pyrexia and Fatigue. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events Pyrexia and Fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients have received an expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that they had received the vaccine on 18-Oct-2021 and on the same day, the vial was stored in the refrigerator. The reporter did not realize that the vial was expired 07-Nov-2021. The reporter also reported that, it was unknown if this was the patient's first, second or booster doses. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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 medicines were reported.  No treatment medicines were reported.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, COVID-19
Clinical narrative: COVID; Diagnosed with COVID but no symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. 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. In August 2021, the patient experienced ASYMPTOMATIC COVID-19 (Diagnosed with COVID but no symptoms). In September 2021, the patient experienced COVID-19 (COVID) (seriousness criterion death). The patient died on an unknown date. The reported cause of death was covid. It is unknown if an autopsy was performed. At the time of death, ASYMPTOMATIC COVID-19 (Diagnosed with COVID but no symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected adverse events of special interest of Asymptomatic COVID-19 and COVID-19. The event occurred on an unknown number of days after receiving an undisclosed dose number of mRNA-1273 Vaccine and had a fatal outcome, with death occurring on an unknown date. The reported cause of death was COVID. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: follow up received has no new information; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected adverse events of special interest of Asymptomatic COVID-19 and COVID-19. The event occurred on an unknown number of days after receiving an undisclosed dose number of mRNA-1273 Vaccine and had a fatal outcome, with death occurring on an unknown date. The reported cause of death was COVID. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: COVID
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received booster 5 months after second vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine) had resolved.        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. Patient had a booster dose.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness in left arm injection site; swelling in left arm injection site; light fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (redness in left arm injection site), VACCINATION SITE SWELLING (swelling in left arm injection site) and FATIGUE (light fatigue) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 025L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in left arm injection site), VACCINATION SITE SWELLING (swelling in left arm injection site) and FATIGUE (light fatigue). At the time of the report, VACCINATION SITE ERYTHEMA (redness in left arm injection site), VACCINATION SITE SWELLING (swelling in left arm injection site) and FATIGUE (light fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-391809, MOD-2021-391815 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received booster 5 months after second vaccine/received booster dose of Moderna COVID-19 vaccine 1 month early.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine/received booster dose of Moderna COVID-19 vaccine 1 month early.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine/received booster dose of Moderna COVID-19 vaccine 1 month early.). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine/received booster dose of Moderna COVID-19 vaccine 1 month early.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given. Patient received booster dose of Moderna COVID-19 vaccine 1 month early.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were Reported. No Treatments were Reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: 108 doses given instead of 120; Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (108 doses given instead of 120) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ACCIDENTAL OVERDOSE (108 doses given instead of 120) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). In 2021, ACCIDENTAL OVERDOSE (108 doses given instead of 120) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided. The vial was initially stored in the refrigerator on 16-Sep-2021. Vaccines was administered from 18-Oct-2021 to 02-Nov-2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported:  Date the vial was initially stored in the refrigerator: 16-Sep-2021. One dose of expired vaccine was administered on 22-Oct-2021 out of 108 doses.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vestibular migraine
Clinical narrative: Vestibular migraine; vertical/constant dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (vertical/constant dizziness) and VESTIBULAR MIGRAINE (Vestibular migraine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (vertical/constant dizziness). On an unknown date, the patient experienced VESTIBULAR MIGRAINE (Vestibular migraine). The patient was treated with VENLAFAXINE for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (vertical/constant dizziness) had not resolved and VESTIBULAR MIGRAINE (Vestibular migraine) outcome was unknown.            No relevant concomitant medications were reported.  The patient reported that she had constant dizziness for 7months.