chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT RECIEVED A PFIZER BOOSTER SHOT 2 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our Private contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our Private was given the same information as above and referred to the immunization division at the Private. Our Private contacted the DOH but she was asked to confer with either Medical Doctor or the standing order physician. Our Private was able to interact with the latter, and she was given the guidance of re-vaccinating. In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT, RECIEVED A PFIZER BOOSTER SHOT 1 DAY AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the expiration date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  It was reported that the vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date. This case contains information for the 12th of 45 adult patients described by the reporter. The date the lot 031B21A was stored in standard freezer was reported as 31-Mar-2021.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2022: Upon internal Review on 29-Jul-2022, significant correction was performed. The case was updated from invalid to valid. Updated classification, vaccine start date, expiration date, event onset date, event verbatim and narrative.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored after beyond use date and CDC expiry date; Vaccine was administered after beyond use date and CDC expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   It was reported that patient took vaccine on 08-Apr-2022, after the CDC expiration date i.e on 02-Apr-2022.The BUD date was reported as 02-Apr-2022. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information provided.  Date Stored in Standard Freezer for the lot 068H21A was 2 degrees F high, -1 degrees F low on 04-Jan-2022.   No treatment medication was reported.  This case contains information for the 36th of 45 patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was administered after beyond use date and CDC expiry date; Vaccine was administered after beyond use date and CDC expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The vial was stored in standard freezer for the lot 031B21A with 2 degrees F high -1 degrees F low on 31-Mar-2021. The BUD date and CDC expiry date was reported as 22-Sep-2021.   No treatment medication was reported.  This case contains information for the eleventh of 45 patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 prophylaxis.     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 (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The BUD date was reported as 08-Sep-2021. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information provided.  Date Stored in Standard Freezer for the lot 007B21A was 2 degrees F high, -1 degrees F low on 16-Mar-2020.   Treatment information was not provided.  This case contains information for the 37th of 45 adults described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022; 4 patients received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 051F21A and 051F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient had not reported any adverse events after first and second dose and after second booster no other adverse reactions are known .  No treatment medications were reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022; patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 031A21A and 039A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the patient did not reported any adverse events after first and second dose and after second booster no other adverse reactions are known of.   On 21-Jul-2022, the vial was initially stored in the refrigerator.  Number of doses or vials includes 4 doses.  The vial did not undergo any temperature excursions.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. The vaccine was stored in standard freezer on 04-Jan-2022. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 18-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The BUD date was reported as 26-Mar-2022. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information provided.  The vaccine was stored in standard freezer on 30-Nov-2021.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered to 45 patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date. This case contains information for the 15th of 45 adult patients described by the reporter. The date the lot 007B21A was stored in standard freezer was reported as 16-Mar-2021. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2022: Upon internal Review on 29-Jul-2022, significant correction was made to update case as valid, updated classification. Updated vaccine start date, expiration date , event onset date and narrative.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient took vaccine on 28-Oct-2021, after the expiration date on 22-Sep-2021. The BUD date was reported as 22-Sep-2021. All 45 patients were adults, who received the Moderna vaccine beyond the 30 day use by date and no additional information provided. Doses was stored in standard freezer for the lot 031B21A 2 degrees F high -1 degrees F low on 31-Mar-2021 was reported.  No treatment medication was reported. This case contains information for the 39 of 45 patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  It was reported that patient took vaccine on 18-Nov-2021, after the expiration date i.e on 22-Sep-2021.The BUD date was reported as 22-Sep-2021.   On 31-Mar-2021,the vaccines were stored in standard freezer for the lot 031B21A was 2 degrees F high, -1 degrees F low .   No treatment medication was reported.  This case contains information for the sixteenth of 45 patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received the Moderna vaccine beyond the 30-day use by date; Vaccine administered to 40th patient of 45 patient past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 40th patient of 45 patient past 30-day use by date) and PRODUCT STORAGE ERROR (Patient received the Moderna vaccine beyond the 30-day use by date) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 40th patient of 45 patient past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the Moderna vaccine beyond the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 40th patient of 45 patient past 30-day use by date) and PRODUCT STORAGE ERROR (Patient received the Moderna vaccine beyond the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date.  Concomitant medication details were not reported by the reporter.  On 31-Mar-2021, vial was stored in standard freezer for the lot 031B21A was 2 degrees F high to 1 degrees F low. A total of 45 doses from the outlined lot numbers were administered past the expiration date.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 08-SEP-2022 and patient administered on 15-NOV-2022; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccine was expired on 08-SEP-2022 and patient administered on 15-NOV-2022) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 08-SEP-2022 and patient administered on 15-NOV-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccine was expired on 08-SEP-2022 and patient administered on 15-NOV-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The BUD date was reported as 08-SEP-2021. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information was provided. Date Stored in Standard Freezer for the lot 007B21A was 2 degrees F high, -1 degrees F low on 16-MAR-2022. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to patient past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 003C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The BUD was reported as 08-Apr-2022. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information was provided. Date Stored in Standard Freezer for the lot 003C21A was 2 degrees F high, -1 degrees F low on 22-Apr-2021.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 22-Sep-2021 and patient administered on 08-Apr-2022; Patient received the Moderna vaccine beyond the 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was expired on 22-Sep-2021 and patient administered on 08-Apr-2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 22-Sep-2021 and patient administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was expired on 22-Sep-2021 and patient administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case contains information on 18th of 45 adult patients as described by the reporter.  No concomitant medication was reported.    It was reported that patient took vaccine on 08Apr2022, after the date reported as 22Sep2021. The expiration date reported as 22 Sep 2021.  All 45 patients were adults, who received the Moderna vaccine beyond the 30 days use by date and no additional information provided. Doses stored in standard freezer for the lot 031B21A with 2 degrees F high and minus 1 degrees F low on 31Mar2021 was reported.   No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. As per the provider the vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. Moderna doses Stored in standard freezer. Date Stored in Standard Freezer was on 31-mar-2021. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored after CDC expiry date; Vaccine administered to patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patients past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patients past 30-day use by date) and PRODUCT STORAGE ERROR (Vaccines were stored after CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  CDC expiry date was reported as 02-Apr-2022 for Lot-068H21A.   Date Stored in Standard Freezer for the lot 068H21A was 2 degrees F high, -1 degrees F low on 01-Apr-2022.  No treatment medication was reported.  This case contains information for the 19 of 45 patients described by the reporter.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator and administered to the patient past expiration date 22-Dec-2021; Patient administered dose past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator and administered to the patient past expiration date 22-Dec-2021) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator and administered to the patient past expiration date 22-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered dose past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator and administered to the patient past expiration date 22-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 28-Jul-2021, the beyond the use date was started.   It was reported that, the vaccines were stored in refrigerator and temperature ranges were between 2 to 5 Celsius. On 22-Dec-2021, the vaccine was expired and on 04-Feb-2022 administered to the patient past the expiration date.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored after beyond use date and expiry date; 45 doses were administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (45 doses were administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (45 doses were administered past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (45 doses were administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that on 30-Nov-2021 vaccines were stored in a standard freezer maintained at 2 degrees Fahrenheit high to minus 1 degrees Fahrenheit low.  No treatment drug was reported. This case contains information for the 43rd of 45 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 003C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. Date vaccine stored in Standard Freezer on 22-Apr-2021. No treatment medications were reported. This case contains 20th patient information out of 45 patients.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 22-SEP-2021 and patient administered on 29-DEC-2021; Vaccine administered to 44th patient of 45 patient past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 44th patient of 45 patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccine was expired on 22-SEP-2021 and patient administered on 29-DEC-2021) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 44th patient of 45 patient past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 22-SEP-2021 and patient administered on 29-DEC-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 44th patient of 45 patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccine was expired on 22-SEP-2021 and patient administered on 29-DEC-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date.  Date the vial was stored in standard freezer 31-Mar-2021 (2 degrees F high    -1 degrees F low). The BUD reported as on 22 S ep 2021.     No treatment information was reported.  This case is of 44th of 45 patients.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022/ Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Patient received the Moderna vaccine beyond the 30-day use by date/ Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date/ Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022/ Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date/ Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022/ Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date/ Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022/ Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   It was reported that patient took vaccine on 08-Apr-2022, after the expiration date i.e on 02-Apr-2022. The BUD date was reported as 02-Apr-2022. The vaccine was moved from the fridge on 08-Apr-2022. No additional information provided. Date Stored in Standard Freezer for the lot 068H21A was 2 degrees F high -1 degrees F low on 04-JAN-2022.   No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  It was reported that vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date.  All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date. No additional information provided.   No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis. No Medical History information was reported. On 30-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported.  All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information provided. Date Stored in Standard Freezer for the lot 021F21A was 2 degrees F high, -1 degrees F low on 30-Nov-2021.  No treatment medication was reported. This case contains information for the 22nd of 45 adults described by the reporter.