chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Epstein-Barr virus test, Fibrin D dimer, Herpes virus infection, Thrombosis
Clinical narrative: Test positive for the  Dimer test for blood clots; The ebv test  for herpes virus; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Test positive for the  Dimer test for blood clots) 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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, the patient experienced THROMBOSIS (Test positive for the  Dimer test for blood clots) (seriousness criterion medically significant) and HERPES VIRUS INFECTION (The ebv test  for herpes virus). At the time of the report, THROMBOSIS (Test positive for the  Dimer test for blood clots) and HERPES VIRUS INFECTION (The ebv test  for herpes virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2022, Epstein-Barr virus test: (Positive) Positive. On 23-Apr-2022, Fibrin D dimer: (Positive) Positive.         Concomitant medications were not reported. No treatment information was provided by the reporter. It was reported that patient wanted to know why people had to take the Dimer test for blood clots and the ebv test for herpes virus, after getting vaccinated, because 80 percent of people were going to test positive after getting vaccinated.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Thrombosis and the non-serious event of Herpes virus infection. Approximately 1 year after receiving the primary series of mRNA-1273 vaccine, the second dose given one month after the first dose, patient tested positive for the Dimer test for blood clots and the ebv test for herpes virus. There is no available information regarding the clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Thrombosis and the non-serious event of Herpes virus infection. Approximately 1 year after receiving the primary series of mRNA-1273 vaccine, the second dose given one month after the first dose, patient tested positive for the Dimer test for blood clots and the ebv test for herpes virus. There is no available information regarding the clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 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 11-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-May-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 01-Apr-2022. No treatment medications were reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: all crawled up after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (all crawled up after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Autoimmune disorder (autoimmune disease).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (all crawled up after getting the vaccine). At the time of the report, VACCINATION COMPLICATION (all crawled up after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-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 02-Apr-2022 and patient administered on 08-Apr-2022) 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 (Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-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 02-Apr-2022 and patient administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. 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 was 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 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. 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 (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 CDC Expiration 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 was 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 medications were reported.   This case was linked to MOD-2022-614356 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 17-Dec-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 17-Dec-2021 and patient administered on 08-Apr-2022) 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 (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 17-Dec-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 17-Dec-2021 and patient administered on 08-Apr-2022) 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 08Apr2022, after the expiration date on 17Dec2021. The date was reported as 17Dec2021. 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 003C21A with 2 degrees F high and minus 1 degrees F low on 22Apr2021 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 (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 (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. 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 2 degrees F high and minus 1 degrees F low was 30-Nov-2021. No treatment medication was reported.
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 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 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 administered to patient past 30-day use by 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 administered to patient past 30-day use by 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.   This case contains information for the 5th of 45 female patients described by the reporter.  No concomitant medication was 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. 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored after beyond use date and expiry date; vaccines 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 (vaccines 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. 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 (vaccines 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 (vaccines 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 the on 31-Mar-2021, vaccines were stored in a standard freezer maintained at 2 degrees Fahrenheit high to minus 1 degrees Fahrenheit low. The date and expiry date was reported as 22-Sep-2021. No treatment drug was reported. This case contains information for the 27th 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 lowon 4Jan2022; 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 lowon 4Jan2022) 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 22-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-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 lowon 4Jan2022). 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 lowon 4Jan2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Vaccine was initially stored in refrigerator on 4Jan2022 and beyond used date for the product was 2Apr2022.  No treatment drug information was provided. Case is reported for the sixth out of 45 patients who had received expired vaccine as reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine stored beyond use by date; Vaccine administered to patient beyond 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 beyond use by date.) and PRODUCT STORAGE ERROR (Moderna vaccine stored beyond use by 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 patient beyond use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine stored beyond use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient beyond use by date.) and PRODUCT STORAGE ERROR (Moderna vaccine stored beyond use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Date the vial was stored in standard freezer was 04-Jan-2022 (2 degrees F high -1 degrees F low) Treatment information was not 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; 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 (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). 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 (Patient received the Moderna vaccine beyond the 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 01-Apr-2022. No treatment medications were reported. This case contains 7th patient information out of 45 patients.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored after beyond use date and expiry date; Vaccine administered to 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 past 30-day use by 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. 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 past 30-day use by 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 (Vaccine administered to past 30-day use by 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 medication were reported.   The date was reported as 02-APR-2022.   The vial was stored in standard freezer for the lot 068H21A with 2 degrees F high and -1 degrees F low on 04-JAN-2022.  No treatment medication were reported.  This case contains information for the twenty ninth of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
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 medications were reported.  It was reported that the vial was stored in standard freezer for the lot 068H21A with 2 degrees F high -1 degrees F low on 04-Jan-2022.  The beyond use date and CDC expiry date was reported as 02-Apr-2022.  No treatment information was provided by the reporter.  This case contains information for the thirtieth of 45 patients 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
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 medications were reported.  It was reported that the vial was stored in standard freezer for the lot 068H21A with 2 degrees F high -1 degrees F low on 04-Jan-2022.  The beyond use date and CDC expiry date was reported as 02-Apr-2022.  No treatment information was provided by the reporter.  This case contains information for the eighth of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master Case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 17-Dec-2021 and patient administered on 08-Apr-2022.; 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 (Vaccine was expired on 17-Dec-2021 and patient administered on 08-Apr-2022.) 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 (Vaccine was expired on 17-Dec-2021 and patient administered on 08-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccine was expired on 17-Dec-2021 and patient administered on 08-Apr-2022.) 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 08Apr2022, after the expiration date on 17Dec2021. The date was reported as 17Dec2021. 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 003C21A with 2 degrees F high and minus 1 degrees flow on 22Apr2021 was reported.  No treatment medication was reported. This case contains information for the 31 of 45 patients described by the reporter.
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 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 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 administered to patient past 30-day use by 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 administered to patient past 30-day use by 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.   The BUD date was reported as 02-Apr-2022. 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 ninth of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
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 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 (Vaccine was administered after beyond use date and CDC expiry 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 03-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-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 (Vaccine was administered after beyond use date and 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 (Vaccine was administered after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  The vial was stored in standard freezer for the lot 031B21A with 2 degrees F high -1 degrees Flow on 31-Mar-2021.  The BUD date and CDC expiry date was reported as 22-Sep-2021.   No Treatment medication reported.  This case contains information for the 32 of 45 patients described by the reporter.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature; Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature) in an 80-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The vial was first punctured on 25-Jul-2022 around 10 AM and then it was left unattended and kept at room temperature range (8 to 25 degree Celsius/46 to 77 degree Fahrenheit) for 23 hours. The vial did not undergo any temperature excursion.  It was reported that the vial was never in the fridge and it was moved from the freezer to room temperature directly on 25-Jul-2022.  No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in freezer but 2 degrees F high -1 degrees F low; Vaccine administered to patient past the expiration 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 the expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in freezer but 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 patient past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in freezer but 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in freezer but 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 drugs were not reported. The vial was stored in standard freezer on 30-Nov-2021 at 2 degrees F high and -1 degrees F low. Treatment medications were not provided. The case is reported for the 10 of 45 patients.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine was stored in a standard freezer after CDC expiration; Vaccine administered to patient past the expiration 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 the expiration date) and PRODUCT STORAGE ERROR (vaccine was stored in a standard freezer after CDC expiration) 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 patient past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was stored in a standard freezer after CDC expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date) and PRODUCT STORAGE ERROR (vaccine was stored in a standard freezer after CDC expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. It was reported that the vial administered was stored in standard freezer on 04-Jan-2022 with temperature 2 Degrees F high and -1 Degrees F low. This case contains information for the 33 of 45 patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were stored after beyond use date and expiry date; Vaccine was administered after beyond use date and 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 expiry 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 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and expiry 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 (Vaccine was administered after beyond use date and expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The date and expiry date was reported as 22-Sep-2021.   The vial was stored in standard freezer for the lot 031B21A with 2 degrees F high -1 degrees Flow on 31-Mar-2021.  No treatment medication were reported.  This case contains information for the eleventh of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
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 were reported.  The BUD date and CDC expiry date was reported as 02-Apr-2022.  The vial was stored in standard freezer for the lot 068H21A with 2 degrees F high -1 degrees F low on 14-Jan-2022. No treatment medication were reported. This case contains information for the thirty fourth of 45 patients described by the reporter.
Sex: U
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 3 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 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 either PHARMACY 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak on face
Age: 77.0
Sex: M
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 3 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 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 either PHARMACY 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.
Age: 64.0
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 3 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 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, Product storage error
Clinical narrative: Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022/ Doses was stored in standard freezer on 01Apr2022; 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 02-Apr-2022 and patient administered on 08-Apr-2022/ Doses was stored in standard freezer on 01Apr2022) 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). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022/ Doses was stored in standard freezer on 01Apr2022). 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 02-Apr-2022 and patient administered on 08-Apr-2022/ Doses was stored in standard freezer on 01Apr2022) 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 08Apr2022, after the expiration date on 02Apr2022. The BUD date was reported as 02Apr2022. 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 068H21A with 2 degrees F high and minus 1 degrees flow on 01Apr2022 was reported. No treatment medication was reported.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Sleep disorder, Urticaria
Clinical narrative: Hives starting on her belly and under her right arm and spread to her back. Very itchy and woke her up from sleeping. Noticed around 11 pm when moving her into bed.