chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment medication was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 17-May-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.            No concomitant medication information provided. No treatment medication information provided. The causality of event COVID-19 with Moderna vaccine was possible while the causality of event COVID-19 with Rinvoq was not reported.  Company comment: This spontaneous case concerns a 65 year old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred after receiving a dose of mRNA1273 as third dose of COVID-19 vaccine (unspecified date of vaccination). Further details on the clinical course, diagnostic test and treatment regimen were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65 year old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred after receiving a dose of mRNA1273 as third dose of COVID-19 vaccine (unspecified date of vaccination). Further details on the clinical course, diagnostic test and treatment regimen were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hangover, Neurological symptom
Clinical narrative: FLARE/SYMPTOMS WERE WORSENING/EXPERIENCING NEUROLOGICAL SYMPTOMS; COVID-vaccine issue / felt like Hangover; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (FLARE/SYMPTOMS WERE WORSENING/EXPERIENCING NEUROLOGICAL SYMPTOMS) and HANGOVER (COVID-vaccine issue / felt like Hangover) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, citrate free. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (FLARE/SYMPTOMS WERE WORSENING/EXPERIENCING NEUROLOGICAL SYMPTOMS) and HANGOVER (COVID-vaccine issue / felt like Hangover). At the time of the report, NEUROLOGICAL SYMPTOM (FLARE/SYMPTOMS WERE WORSENING/EXPERIENCING NEUROLOGICAL SYMPTOMS) and HANGOVER (COVID-vaccine issue / felt like Hangover) outcome was unknown.            No concomitant medications were provided by the reporter. It was unknown if the patient was enrolled in a COVID-19 vaccination trial. It was mentioned that primary reporter contact for lot number information was not available. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that, vaccines administered at pharmacies that were stored in an unapproved freezer and thus might have been compromised. At pharmacy, digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The Beyond Use Date of vaccine  was reported as 01-DEC-21 to 15-DEC-21 The Moderna ordered date was reported as 01-Nov-2021 and 15 Nov. No treatment medication information was given.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Psoriatic arthropathy, Vaccination site pain
Clinical narrative: Psoriatic arthritis aggravated/ General body pain/body soreness; Vaccination site pain/soreness in ijection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ General body pain/body soreness), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/soreness in ijection site) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ General body pain/body soreness), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/soreness in ijection site). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ General body pain/body soreness) had not resolved and FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/soreness in ijection site) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient experienced vaccine caused fatigue for a day, soreness in injection site, body soreness and occasional psoriatic arthritis flare up. The daily dose of SPIKEVAX was reported as 1 in 1 once. It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Potential AE due to doses administered from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Potential AE due to doses administered from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Potential AE due to doses administered from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Potential AE due to doses administered from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Moderna ordered date was 01-Nov-2021 and 15-Nov-2021 The beyond use date of the vaccines was reported as 01-Dec-2021 to 15-Dec-2021. No concomitant medications information was reported.  Reporter stated that they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Administered vaccine from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Administered vaccine from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. MODERNA DATE ORDERED was reported as 01-Nov-2021 and 15-Nov-2021. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) 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 digital data loggers and freezers expired before they were re-calibrated. The reporter was aware in some of the freezers there was a temperature excursion that the data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they have paper logs to monitor those temperatures.  The reporter wanted to know whether need to take any action since the vaccines stored in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Administered vaccine from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. Moderna vaccine was ordered on 01-Nov-2021 and 15-Nov-2021. The beyond use date of the vaccine was reported as 01-Dec-2021 to 15-Dec-2021. The reporter reported that they had a group of 13 pharmacies that had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. They wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. The reporter asked whether they need to take any action in relation to the doses administered since the vaccines were stored in an unapproved freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Moderna vaccine was ordered on 01-Nov-2021 and 15-Nov-2021.  The beyond use date of the vaccine was reported as 01-Dec-2021 to 15-Dec-2021.  The reporter reported that they had a group of 13 pharmacies that had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed.  They wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.  The reporter asked whether they need to take any action in relation to the doses administered since the vaccines were stored in an unapproved freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment information was provided.