chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C; Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 19-Feb-2021, Pfizer vaccine on 12-Mar-2021 and Pfizer vaccine on 02-Nov-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Storage condition of the vaccine at the time of the excursion was reported as stored in the refrigerator. The vial undergo temperature excursions of plus1.9C to plus 6.4 C.\ with excursion duration of 15 min. Number of doses or vials were 2. Date and time vial was first punctured was on 15 Jun 2022 at 9.15 AM. Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F.  No treatment medication were reported.   This case was linked to MOD-2022-590514, MOD-2022-590536 (Patient Link).
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 Vaccine (Dose 1) on 22-Jan-2021, Pfizer COVID-19 Vaccine (Dose 2) on 11-Feb-2021 and Pfizer COVID-19 Vaccine (Dose 3) on 25-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine, Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine. On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. Date and time vial was first punctured was on 15-Jun-2022 at 9:15 AM. The vial was stored in portable fridge post puncture. The vaccine expiry date was reported as 05-Jul-2022. The vial undergo temperature excursions of plus 1.9C to plus 6.4 C for 15 minutes. Total amount of time the vial was exposed to room temperature range 8° to 25°C that is 46° to 77°F. Storage condition at the time of the excursion was Refrigerator. Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022 Visual inspection noting any vaccine state change was thawed. No treatment medication were reported.
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Pfizer (1st dose) on 07-Jan-2021, Pfizer (2nd dose) on 28-Jan-2021 and Pfizer (3rd dose) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. 2 doses/vials were impacted (1 punctured and 1 not punctured). The vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial 15-Jun-2022. The vial was first punctured on 15-Jun-2022 at 9.15 AM. The vial was stored in portable fridge post puncture. The vial undergoes temperature excursions on +1.9C to +6.4 C. Excursion duration was 15 min.. All the vials were in the fridge quarantined. Visual inspection noting any vaccine state change included vial was thawed. No treatment medications were provided by the reporter.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 28-Jan-2021, Pfizer (Dose 2) on 18-Feb-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) 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 and time vial was first punctured was on 15-Jun-2022 at 9.15 AM, the vial undergo temperature excursions of plus 1.9C to plus 6.4 C for 15 mins. Storage condition at the time of the excursion was Refrigerator. Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022. Visual inspection noting any vaccine state change was thawed. Proposed desired use by date was 15-Jun-2022 afternoon. No treatment medications were reported.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion for 15 minutes at the site; Vaccine administered that went under temperature excursion for 15 minutes at the site; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (Dose 1) on 28-Jan-2021, Pfizer (Dose 2) on 18-Feb-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The data logger at the clinic was not set with correct parameters and temperature excursion happened with the vial.  Number of doses/vials that were administered from that lot was 2 (1 punctured and 1 not punctured).  The vial was previously stored in fridge.  The vial was moved from freezer to refrigerator on 15-Jun-2022.  The vial was first punctured on 15-Jun-2022 at 9.15 AM.  The vial was stored in portable fridge post puncture.  The vial underwent temperature excursion for about 15 minutes having minimum temperature of 1.9 degree Celsius and maximum temperature of 6.4 degree Celsius. The dose was administered to the patient within less than 12 hours post puncture.  Proposed desired use by date and time of the vial was 15-Jun-2022 (afternoon).  The vial was returned to fridge and quarantined after administration.  Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022; The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022) and EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 065F21A, 023C21A and 047B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-May-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022). At the time of the report, PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022) and EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  On 24-May-2022 patient was given expired (4 days expired) Moderna vaccine lot 033K212A manufacturer expiration date 20-May-2022 IM 0.25mL as a fourth dose.  Reporter reported that Moderna vaccine lot 033K212A manufacturer expiration date 20-May-2022 was taken out of freezer on 20-Apr-2022. Out of freezer expiration date 20-May-2022.  No treatment medication information provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine administered that went under temperature excursion; Vaccine administered that went under temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     The patient was not sick or had no fever on the day of vaccination. The patient did not have an allergic reaction to polysorbate, polyethylene glycol or a previous dose of COVID-19 vaccine. The patient did not have a serious allergic reaction (anaphylaxis) to another vaccine or any injectable medication, foods, venom, environmental oral medications. The patient had no bleeding disorder and was not on long term aspirin therapy or did not took other blood thinners. The patient did not have Guillian-Barre syndrome (a type of temporary severe weakness) after receiving the vaccine. The patient did not receive any dermal fillers. The patient had no history of blood clots or risk factors for developing blood clots,  myocarditis or pericarditis, heparin induced thrombocytopenia (HIT) and multisystem inflammatory syndrome. The patient was not immunocompromised.     On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received booster dose.  Date and time vial was first punctured was on 15-Jun-2022 at 9.15 AM, the vial undergo temperature excursions of plus 1.9 degrees C to plus 6.4 degrees C for 15 mins.   Storage condition at the time of the excursion was Refrigerator.  Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022. The proposed desired use by date provided was on the afternoon of 15-Jun-2022  No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 011F21A, 010A21A and 042L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported.   The vial was initially stored in the refrigerator on 20-Apr-2022. Freezer expiration date was reported as 20-May-2022. On 24-May-2022, patient was given expired (4 days expired) Moderna vaccine lot 033K212A manufacturer expiration date 20-May-2022, Other vaccines were given on the same day of Moderna COVID-19 vaccine were reported as none. The vial did not undergo any temperature excursions.   Treatment information was not reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use or after manufacture date of expiry) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 20-Apr-2022 and administered on 24-May-2022) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A and 069H21A) for COVID-19 vaccination. Previously administered products included for Drug use for unknown indication: PFIZER (Dose- 1, Batch lot number-EW0175, ROA-IM, left deltoid, Dose/Volume-0.3 ml) on 23-Jun-2021, PFIZER (Dose- 2, Batch lot number-EW0191 ROA-IM and Dose/Volume-0.3 ml) on 14-Jul-2021. Past adverse reactions to the above products included No adverse event with PFIZER and PFIZER. On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use or after manufacture date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 20-Apr-2022 and administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use or after manufacture date of expiry) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 20-Apr-2022 and administered on 24-May-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications was provided by the reporter. Number of doses or vials administered 13 booster in 1vial. The Vial was initially stored on refrigerator on 20-Apr-2022. The vial had not undergone any temperature excursion. No treatment medications were reported
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion of +1.9C to +6.4 C; Vaccine administered that went under temperature excursion of +1.9C to +6.4 C; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1) on 28-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 18-Feb-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, Pfizer and Pfizer.    On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of +1.9C to +6.4 C) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was stated that, the data logger was not set with correct parameter and excursion happened for 15 mins at the site + 1.9 Celsius (C).  The storage condition at the time of the excursion was refrigerator and maximum or minimum temperatures reached, as applicable was +1.9 C to +6.4C for 15 minutes. On 15-Jun-2022, the vial moved from freezer to refrigerator. At 09:15 am, the vial was initially punctured.  Vial was currently fridge quarantined in portal fridge.   The visual inspection noting any vaccine state change stated thawed. The proposed desired Use by Date was stated as afternoon.  No treatment medications were reported.
Age: 94.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion; Vaccine administered that went under temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion) in a 94-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1) on 07-Jan-2021, Pfizer (Dose 2) on 28-Jan-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022. Proposed desired use by date was 15-Jun-2022 afternoon. Date and time vial was first punctured was on 15-Jun-2022 at 9.15 AM, the vial undergo temperature excursions of plus 1.9 C to plus 6.4 C for 15 mins. Storage condition at the time of the excursion was Refrigerator.  Visual inspection noting any vaccine state change was thawed.  No treatment medications were reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; Patient had full forth dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and ACCIDENTAL OVERDOSE (Patient had full forth dose) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Jun-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and ACCIDENTAL OVERDOSE (Patient had full forth dose). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and ACCIDENTAL OVERDOSE (Patient had full forth dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. On 08Jun2022 vial moved from freezer to refrigerator. Excursion duration 15 min. The vials stored in Fridge quarantined and was thawed. The vial first punctured on 15Jun2022 at 9.15 AM. The vial stored in portable fridge. The vial undergone 1.9C to 6.4 C temperature excursions. Treatment information was not provided.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1) on 28-Jan-2021, Pfizer (Dose 2) on 18-Feb-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was stated that, the data logger was not set with correct parameter and excursion happened for 15 mins at the site + 1.9 Celsius (C). The storage condition at the time of the excursion was refrigerator and maximum or minimum temperatures reached, as applicable was +1.9 C to +6.4C for 15 minutes. On 15-Jun-2022, the vial moved from freezer to refrigerator. At 09.15 am, the vial was initially punctured. Vial was currently fridge quarantined in portable fridge. The visual inspection noting any vaccine state change stated thawed. The proposed desired Use by Date was stated as afternoon of 15-Jun-2022.  No treatment medications were reported.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 07-Jan-2021, Pfizer (Dose 2) on 28-Jan-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The expiration date was 05-Jul-2022. Two doses/vials were impacted (1 punctured and 1 not punctured).  The vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial 15-Jun-2022. The vial was first punctured on 15-Jun-2022 at 9.15 AM. The vial was stored in portable fridge post puncture. The vial underwent temperature excursions on plus 1.9C to plus 6.4 C. Excursion duration was 15 min. Vial was stored in the refrigerator at the time of the excursion. The vial was thawed. Proposed desired use by date was 15-Jun-2022 afternoon. All the vials were in the fridge quarantined. Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     It was reported that patient had no allergies, had not received any dermal filters, did not have a history of myocarditis or pericarditis, blood clots, heparin induced thrombocytopenia or multisystem inflammatory syndrome after a COVID-19 infection and patient was not immunocompromised.  Concurrent medical conditions included Haemorrhagic disorder (on long-term aspirin therapy or took other blood thinners).    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the dose was administered 12 hours post puncture. The vial was first punctured on 15-Jun-2022 at 9.15 AM and was stored in portable refrigerator post puncture. Vial underwent a temperature excursion of plus 1.9C to plus 6.4 C for 15 mins. Vial was stored in the refrigerator at the time of the excursion. Vial was moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022. The vial was thawed. Proposed desired use by date was 15-Jun-2022 afternoon. It was confirmed that patient was not sick or did not have fever at the time of reporting.  No treatment medications were reported.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion for 15 minutes at the site; Vaccine administered that went under temperature excursion for 15 minutes at the site; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The data logger at the clinic was not set with correct parameters and temperature excursion happened with the vial.  Number of doses/vials that were administered from that lot was 2 (1 punctured and 1 not punctured).  The vial was previously stored in fridge.  The vial was moved from freezer to refrigerator on 15-Jun-2022.  The vial was first punctured on 15-Jun-2022 at 9.15 AM.  The vial was stored in portable fridge post puncture.  The vial underwent temperature excursion for about 15 minutes having minimum temperature of 1.9 degree Celsius and maximum temperature of 6.4 degree Celsius. The dose was administered to the patient within less than 12 hours post puncture.  Proposed desired use by date and time of the vial was 15-Jun-2022 (afternoon).  The vial was returned to fridge and quarantined after administration.  Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 20-Apr-2022/Vaccine administered on 24-May-2022; Patient was given expired (4 days expired) Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Apr-2022/Vaccine administered on 24-May-2022) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 042L20A, 013M20A and 011F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Apr-2022/Vaccine administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Apr-2022/Vaccine administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was taken out of freezer on 20-Apr-2022 and out of freezer expiration date was 20-May-2022.  The vial did not undergo any temperature excursion.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022, beyond 30 days duration) and PRODUCT STORAGE ERROR (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 017E21A, 010A21A and 042L20A) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022, beyond 30 days duration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022, beyond 30 days duration) and PRODUCT STORAGE ERROR (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug reported. Moderna vaccine lot 033K212A manufacturer expiration date was reported as 10-July-2022 and was taken out of freezer on 20-Apr-2022. There were 13 booster doses in 1 vial. The vial was initially stored in the refrigerator on 20-Apr-2022. Out of freezer expiration date was reported as 20-May-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient 4 days after the expiry) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 20-Apr-2022, its used by date was 20-May-2022 but was administered on 24-May -2022.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 017E21A, 010A21A and 042L20A) for COVID-19 immunisation. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient 4 days after the expiry.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 20-Apr-2022, its used by date was 20-May-2022 but was administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient 4 days after the expiry) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 20-Apr-2022, its used by date was 20-May-2022 but was administered on 24-May -2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The vaccine was refrigerated on 20-Apr-2022, its used by date was 20-May-2022 but was administered on 24-May-2022. Vaccine was administered to the patient 4 days after the expiry. Concomitant drugs were not reported. Treatment details were not given. Vial did not undergo any temperature excursion. This case was linked to MOD-2022-575471 (Patient Link).