chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 27-Oct-2021 at 4:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 27-Oct-2021, Excursion time was 10 AM, temp was 32 , total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021, 4 vial was moved to clinic. Vaccine BUD date was 04-Nov-2021. On 27-Oct-2021, Excursion time was 9 AM, temp was 29 , total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 29-Sep-2021, vial was moved to clinic on 27-Oct-2021, 2 vial was moved to clinic. Vaccine BUD date was 29-Oct-2021.  Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration at 8 AM:41,  9 AM:29, 10 AM: 32, 11 AM:43, 12 AM:43, 1PM : 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45.  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vials only punctured right before administration  Treatment medications were not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  On 27-Oct-2021, Excursion time was 10 AM, temp was 32, total doses given for the day was unkown, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 4 vial was moved to clinic. Vaccine BUD date was 04-Nov-2021.  Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM : 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  Vials only punctured right before administration  It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 64.42.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 9 AM, temp was 34 and at 10 AM temp was 37; total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vial was moved to clinic. Vaccine BUD date was 08-Apr-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:20 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 63.83 years.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 9 AM, temp was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vial was moved to clinic. Vaccine BUD date was 29-Apr-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Patient age was reported as 70.27 years.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was  8A, 9A and 10 A, temperature was 35 and 32, vaccine was not frozen prior to administration. Vaccine moved to fridge on 29-Sep-2021 and moved to clinic on 22-Oct-2021. 1 vials were sent to the clinic. BUD date was 29-Oct-2021. Vials only punctured right before administration.  Vaccine was stored in Cooler 1 on 22-OCT-2021.   Treatment medications were not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:24 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Mar-2021 at 10:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Regarding vial with batch number: 014M20A Date vaccine moved from freezer to refrigerator: 24-Feb-2021. Vaccine moved to clinic on 03-Mar-2021. Vaccine Use by Date was 26-Mar-2021.  Regarding vial with batch number: 030B21A Date vaccine moved from freezer to refrigerator: 30-Mar-2021. Vaccine moved to clinic on 31-Mar-2021. Vaccine Use by Date was 29-Apr-2021. On 31-Mar-2021 at 10:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion).   Vaccines were not frozen at time of administration. Vials only punctured right before administration - during COVID-19 vaccine clinic all doses were drawn from vial due to high-pace clinic. traceable temperature monitor was used to record hourly temperatures. It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:31 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Patient age was reported as 72.73.  The BUD date was reported as 13-Mar-2021 and Date of vaccine moved to fridge was reported as 11-Feb-2021. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    No treatment medication was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 4:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 03-Nov-2021 at 4:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 03-Nov-2021, Excursion time was 10 AM, temp was 35 , total doses given for the day was 117, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021, 6 vial was moved to clinic. Vaccine BUD date was 05-Nov-2021.  Vial was stored on cooler 1 , on 03-Nov-2021, Excursion duration at 8 AM:36,  9 AM:36, 10 AM: 36, 11 AM:35, 12 AM:36, 1PM : 37, 2 PM : 36, 3 PM: 36, 4 PM: 37 and 5 PM : 42.  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vials only punctured right before administration  Treatment medications were not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was 2P, temperature was 35, vaccine was not frozen prior to administration. Vaccine moved to fridge on 08-Jan-2021 and moved to clinic on 11-Jan-2021. 9 vials were sent to the clinic. BUD date was 07-Feb-2021. Vials only punctured right before administration.  Vial was stored on cooler 1 , on 11-Jan-2021, Excursion duration At 9 AM: 34, 10 AM: 37, 11 AM: 37, 12 AM: 35, 1PM : 36, 2 PM : 37, 3 PM: 37.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Concomitant products were not provided.  Vials only punctured right before administration  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 3:43 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:17 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2021 at 3:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 63.78 (at the time of 1st dose) and 63.86 (2nd dose) years.  No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    On 27-Feb-2021, total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were moved to clinic. Vaccine BUD date was 26-Mar-2021 for batch number 014M20A.  On 28-Mar-2021, total doses given for the day was 150, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021 for batch number 019B21A.  Vials only punctured right before administration.  No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 65.97.  Concomitant medications were not provided.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 1:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:34 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Mar-2021 at 1:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored in cooler 1, on 02-Mar-2021, Excursion duration at 9 am: 27, at 10 am 29, at 11 am 32, at 12 am 33, at 1 pm 36, at 2 pm 35, at 3 pm 36, at 4 pm 37 and at 5 pm 37 taken using a Fisherbrand traceable temperature monitor in F On 02-Mar-2021, total doses given for the day was 177, condition of vaccine; prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were moved to clinic. Vaccine BUD date was 26-Mar-2021 for batch number 014M20A.  On 30-Mar-2021, total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021 for batch number 019B21A.  Vials were only punctured right before administration.Vaccines were not frozen at time of administration Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:36 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 8 AM, temp was 32, total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  Vial was stored on cooler 1, on 31-Mar-2021, Excursion duration At 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM:42, 12 AM: 43, 1PM : 44, 2 PM : 46, 3 PM: 46, 4 PM: 44 and 5 PM : 44  Vials only punctured right before administration.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered after more than 1 temperature excursion; Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 65.92 No concomitant medications were reported. The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. Vial was stored on cooler 1 , on 27-FEB-2021, No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 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.  Patient age was 64.34 Years.  The reported condition of the vial was not frozen.  Vaccine underwent temperature excursion on 03 Nov 2021 till 35 degrees Fahrenheit at 10 AM. Vaccine was moved to fridge on 05 Oct 2021 and Beyond Use Date for the vaccine was 05 Nov 2021.  Product moved to clinic on 03 Nov 2021.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 11:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:42 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Mar-2021 at 11:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age was reported as 72.63 on 28-Feb-2021 and 72.71 on 28-Mar-2021    No concomitant product reported by reporter. The reported condition of the vial was not frozen. Vaccine was moved to fridge on 23-Mar-2021, Vaccine was moved to clinic on 27-Mar-2021.Number of vials sent to clinic were 15 and Total doses given for the day were 150 Vaccine underwent temperature excursion on 28-Mar-2021 till 35 degrees Fahrenheit at 10 AM and Best Use Date for the vaccine was 22-Apr-2021. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vial was punctured right before administration. No treatment medication reported by reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 4:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 4:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 66.03 years.  No concomitant product use was reported.   It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 1, on 29-Apr-2021, excursion duration at 9 am 36, at 10 am 33, at 11 am 44, at 12 am 45, at 1 pm 45, at 2 pm 44, at 3 pm 45, at 4 pm 44.  On 29-Apr-2021, excursion time at 10 am temperature was 33, total doses given for the day was 201, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vial was moved to clinic. Vaccine BUD date was 19-May-2021.  Vials only punctured right before administration.  No treatment information was provided.