chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 008C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-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. Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Placed in the fridge on 11-Jan-2022 and administered on 02-MAR-2022; Patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 02-MAR-2022) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 008C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 02-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 02-MAR-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.  A pharmacist, the vaccine coordinator in their facility reported that they inadvertently administered expired dose of the Moderna Covid-19 vaccine.  Date the vial was initially stored in the refrigerator was on 11-Jan-2022, which means that all doses administered more than 30 days after 01-Jan-2022 were not in accordance   The vial did not undergo any temperature excursions.  They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage.  No treatment drugs were reported
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022; Patient received an expired vaccine on 09-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 09-May-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (LOT- FE3592) on 20-Oct-2021 and Pfizer (LOT- FE3590) on 10-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 09-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 09-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 09-May-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The reporter stated that they initially called on 12-May-2022 and reported a total of 18 patients received expired doses after the 30 days Use by Date. On 17-May-2022, the reporter reported after doing further research, that the actual total number of patients that received expired doses after the 30 days use by date was 82 patients total and not 18 patients. The date the vial initially stored in the refrigerator was 11-Jan-2022 which meant that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. Reportedly, the vial didn't undergo any temperature excursions. On 09-MAY-2022, patient took first booster dose of Moderna Vaccine.   The patient had not reported adverse reaction to the reporter's knowledge.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: Truly sick; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Truly sick) and VOMITING (Vomiting) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Truly sick) and VOMITING (Vomiting). At the time of the report, ILLNESS (Truly sick) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 030H21B) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen (Batch no was reported as 1816022.) on 25-May-2021. Past adverse reactions to the above products included No adverse event with Janssen.   On 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-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. Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 014M20A, 038B21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 13-Apr-2022 post 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported.  The patient was inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Vaccine with lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA.  Patient has not reported adverse reaction to the health care professional's knowledge.  The vaccine in question did not experience any temperature excursions.  On 03-Nov-2021, patient received first booster dose. On 13-Apr-2022, patient received second booster dose.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022; inadvertently administered expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566648 (Patient Link).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days; Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to patient on 13-Apr-2022 post 30 days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Pharmacist, the vaccine coordinator in their health care facility, reported that they inadvertently administered an expired dose of the Moderna Covid-19 vaccine. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. The lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which meant that all doses administered more than 30 days after 11-Jan-2022 was not in accordance with the university. The vial did not undergo any temperature excursions.   The patient did not report any adverse reaction to the health care professional knowledge.  No treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 09-Mar-2022; inadvertently administered expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 09-Mar-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 025A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022; patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 20-Apr-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.  A pharmacist, the vaccine coordinator in their health care facility reported that they inadvertently administered expired dose of the Moderna COVID-19 vaccine. Date the vial was initially stored in the refrigerator was on 11-Jan-2022, which meant that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Patient received 2nd booster dose on 20-Apr-2022 and not reported adverse reaction to the HCP's knowledge.  No treatment drugs were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022; Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Lot EN6203) on 01-Apr-2021, Pfizer (Lot EN6203) on 22-Apr-2021 and Pfizer (Lot FE3592) on 06-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial was initially stored in the refrigerator on 11-Jan-2022. Patient received second booster on 20-Apr-2022. The vial did not undergo any temperature excursions. The patient did not reported adverse reaction.  Treatment information was not provided by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 09-Mar-2022; First dose administered on 27-Jan-2022 and second dose administered on 09-Mar-2022; inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge)), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 09-Mar-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 27-Jan-2022 and second dose administered on 09-Mar-2022) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 084J21A and 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 27-Jan-2022 and second dose administered on 09-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge)), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 09-Mar-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 27-Jan-2022 and second dose administered on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with a Regulatory Authority. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days; Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Batch number: EL9265 dose 1) on 29-Jan-2021 and PFIZER BIONTECH COVID-19 VACCINE (Batch number: EN6203 dose 2) on 19-Feb-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days) 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 by pharmacist, the vaccine coordinator in their health care facility, that they inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. The patient did not report any adverse reaction to the health care professional's knowledge.  No treatment medication was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 008C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Vaccine expired on 05 May 2022. It was reported that the reporter had identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient received First booster dose on 09-May-2022. Did not reported any adverse reactions.  Treatment information was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 20-Apr-2022; the vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 20-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 20-Apr-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 024M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (the vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 20-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 20-Apr-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. The vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 004B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-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. Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022; patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 014M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 11-May-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. on 23-Nov-2021 the patient received fourth dose of Pfizer included for Product used for unknown indication. Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patients not had reported any adverse reactions. No treatment medication were provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Mar-2022; Expired dose administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Mar-2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 003B21A and 044B21A) for COVID-19 vaccination.     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 16-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. The patient did not reported adverse reaction.  Treatment information was not provided by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 16-Feb-2022; patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 16-Feb-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 007C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 16-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 16-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.