chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 2:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 2:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine 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.  The age of patient was provided as 35.66.  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.  On 28-Apr-2021, the excursion time on initial supply was 09 am, temperature was 33. Total 150 doses were administered for that day, condition of vaccine prior to vaccination was not frozen. Vaccine moved to fridge on 19-Apr-2021 and moved to clinic on 28-Apr-2021. 04 vials were moved to the clinic. Vaccine BUD date was 19-May-2021.  On 28-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41 and 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 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 during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021 at 4:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Jan-2021 at 4:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 35.29. Concomitant products were not provided. On 06-Jan-2021, Excursion time was 03 PM, temperature was 35, total doses given for the day was 32, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 06-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 27-Jan-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. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was 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 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine 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 35.50.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 6-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 9-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  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.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine 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 37.31.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively,8 AM: not provided, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  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 brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine 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 the patient was 43.58 years.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 6-Apr-2021, vial was moved to clinic on 15-Mar-2021. 18 vials were sent to clinic. Vaccine BUD date was 9-May-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 39, 12 AM: 43, 1PM: 44, 2 PM: 44, 3 PM: 46, 4 PM: 42 and 5 PM: 42.  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.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2022 at 1:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 1:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine 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 46.61.  Concomitant medication was not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 02 PM, 03 PM and temperature was 32, 32, 32, 35, 35 respectively. Total doses given for the day was 162 from 9 AM vial, condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. On 14-FEB-2021, no hourly temperature recordings available.  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. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was 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 and half hour approximately, when temperature data logger registered 34 or 35 degree F.  Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.  Company Comment: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) ADR of Myocarditis, on an unknown date after a dose of mRNA-1273 vaccine. This case is reported by a consumer during a call to medical information, who stated that her next door neighbor has myocarditis after a dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-577107 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) ADR of Myocarditis, on an unknown date after a dose of mRNA-1273 vaccine. This case is reported by a consumer during a call to medical information, who stated that her next door neighbor has myocarditis after a dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:23 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine 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 46.42. Concomitant products were not provided. On 07-jan-2021, Excursion time was 09 AM and 10 AM, with temperature as 34, and 34 respectively. Total doses given for the day was 96 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM and 10AM vaccine was moved to fridge on 05-Jan-2021 and. Vial was moved to clinic on 07-jan-2021. 6 vials from 9 AM and 10 AM were sent to clinic. Vaccine BUD date was 27-jan-2021 for 9AM,10 AM respectively. On 07-jan-2021 no hourly temperature recordings available 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 traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was 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 and half hour 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 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine 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 46.63. Concomitant products were not provided. On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-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 traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was 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 and half hour 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 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 46-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 03-Apr-2021 at 3:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:38 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine 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.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  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 traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-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 31-Mar-2021 at 11:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:20 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine 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 46.48.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 9 AM and temperature was 32, total doses given for the day was not provided. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 30-Mar-2021 and was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46 and 4 PM: 44, 5PM: 44.  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 traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Continued light headiness; Foggy brain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day at the age of 17 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Continued light headiness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Foggy brain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Menstrual disorder
Clinical narrative: Continued light headiness; Foggy brain; wicked fatigue; Abnormal menstrual cycles (2 periods/ month); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Light headiness), for COVID-19 immunisation, reaction(s): "light headiness"; Bnt162b2 (DOSE 1, SINGLE, Foggy brain), for COVID-19 immunisation, reaction(s): "foggy brain". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Apr2021, outcome "not recovered", described as "Abnormal menstrual cycles (2 periods/ month)"; FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "wicked fatigue"; DIZZINESS (non-serious), outcome "not recovered", described as "Continued light headiness"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Foggy brain". The events "continued light headiness", "foggy brain", "wicked fatigue" and "abnormal menstrual cycles (2 periods/ month)" required physician office visit. Therapeutic measures were taken as a result of menstrual disorder. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: currently has a respiratory cough; not an infection or pneumonia; just a cough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient in their 90's received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1,MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: COUGH (non-serious), outcome "unknown", described as "currently has a respiratory cough; not an infection or pneumonia; just a cough".  Additional information: The caller had a question about whether there is any advice or risk for older adults if there's a timeframe for getting the 4th booster dose of Pfizer Covid-19 Vaccine. She explained let's say that a person in their 90s who currently has a respiratory cough; not an infection or pneumonia; just a cough-Is there a time frame that it is best to get or not get the 4th booster dose of Pfizer Covid-19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium
Age: 87.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: No systemic adverse effects-Mild, Additional Details: Per caregiver , adverse effects were not noticed until 05/23/24, 5 days after she got the shots. We agreed she takes benadryl, ibuprofen and use cold packs on the injection site, then gets it checked out by her doctor if she does not feel better in the next few days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: feet tingling-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: feet tingling-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: ONSET OF ADVERSE REACTION REPORTEDLY WAS WITHIN ABOUT AN HOUR AFTER RECEIVING THE VACCINE. PATIENT REPORTED ITCHY RASH NOT RESOLVING TO PHARMACY; PLANS TO TAKE 50MG OF BENADRYL AND TRACK RESPONSE AFTER SHE ARRIVES HOME TODAY.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: ONSET OF ADVERSE REACTION REPORTEDLY WAS WITHIN ABOUT AN HOUR AFTER RECEIVING THE VACCINE. PATIENT REPORTED ITCHY RASH NOT RESOLVING TO PHARMACY; PLANS TO TAKE 50MG OF BENADRYL AND TRACK RESPONSE AFTER SHE ARRIVES HOME TODAY.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Rash
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain, Injection site erythema, Myocardial infarction
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Heart Attack-Severe
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Death, Dyspnoea, Injection site erythema, Myocardial infarction
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Heart Attack-Severe
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Blurry vision post vaccination. My eyes sight also went from 20/20 now  suddenly cannot see clearly close.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Child received first two doses of Pfizer 5-11 at age 11.  At age 12, she received the booster dose of Pfizer vaccine using the age 5-11 dose at the insistence of her parent.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: she started to feel really bad; weakness; fatigue; light headed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 93-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 93 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: controlled by diet and exercise no medicine. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EN6199; Anatomical location: left arm, She has never had a bad reactions.), administration date: 06Mar2021, when the patient was 92-year-old, for Covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 2; Lot Number: ER8730; Anatomical location: left arm), administration date: 27Mar2021, when the patient was 92-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER); Lot Number: 33025BD; Anatomical location: left arm), administration date: 05Jan2022, when the patient was 93-year-old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 13May2022, outcome "not recovered", described as "she started to feel really bad"; FATIGUE (non-serious) with onset May2022, outcome "unknown"; DIZZINESS (non-serious) with onset May2022, outcome "unknown", described as "light headed"; ASTHENIA (non-serious) with onset May2022, outcome "unknown", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, asthenia, fatigue, dizziness.  Additional information: The patient experienced some side effects as a delayed reaction, stating that she felt well the first few days after getting the vaccine and the on 13May2022 she started to feel really bad. On 10May2022 in late afternoon (when vaccine was administered) She was fine the next day and in fact she felt good. The 3rd day and 4th day were really bad days including today. She feels about the same. She feels pretty bad. At her age she does have a bad day every once and a while. Now she has been going on sick for almost 4 days. No additional vaccines administered on same date of the Pfizer suspect. No events require a visit to emergency room or physician office. No other product administered prior vaccinations (within 4 weeks). No relevant tests.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have arm pain. My brother who lives in (city withheld) experience the same pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I have arm pain. My brother who lives in (city withheld) experience the same pain".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200721571 different patient, same drug and event.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Hypertension, Nausea, Pyrexia
Clinical narrative: nausea; fever; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (medically significant), outcome "unknown"; PYREXIA (medically significant), outcome "unknown", described as "fever"; HYPERTENSION (medically significant), outcome "unknown", described as "high blood pressure". The events "nausea", "fever" and "high blood pressure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; Body temperature: Fever. Therapeutic measures were taken as a result of hypertension. The patient's doctor was having difficulty in controlling her blood pressure. The patient had been in the emergency room five times in the last two years. She is afraid to take the 2nd booster. She felt she won't make it through another vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Screaming, Vaccination site swelling
Clinical narrative: had a little leg swelling; baby had been non-stop crying/screaming ever since receiving the vaccines; This is a spontaneous report received from a contactable reporter(s) (Physician). Other Case identifier(s): 2022SA145228 (Sanofi case number).  A 2-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 20Apr2022 as single dose (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), (Batch/Lot number: unknown); cinacalcet hydrochloride (ROTOCALCET), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CRYING (non-serious) with onset Apr2022, outcome "recovered", described as "baby had been non-stop crying/screaming ever since receiving the vaccines"; VACCINATION SITE SWELLING (non-serious) with onset Apr2022, outcome "recovered", described as "had a little leg swelling". The action taken for diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid and cinacalcet hydrochloride was unknown.  Additional information: It was reported Patient: 2 month Old male patient Product: Pentacel Event(s): Wednesday. 20Apr2022, patient was vaccinated with Pentaccl, Prevnar and Roto liquid around noon, left leg, Parent called afterhours number around 9pm and reported that the baby had been non-slop crying/screaming eve: since receiving the vaccines. The baby also had a little leg swelling. parent did stale that the baby slept an hour or two but When awake began to cry/scream again. Physician shared she was in touch With the parent multiple times throughout the evening and night, She also saw the baby first thing this morning and the baby seemed fine. The baby was no longer crying and didn't seem to have any swelling or redness of the left leg. Physician is ok to receive follow up, Action taken with Diphtheria, Tetanus, Ac Pertussis. IPV And Bib Vaccine (Pentacel), Pneumococcal V Accine Conj 7V (CRM197) (Prevnar) and rolo liquid was not applicable. It was not reported if the patient received a corrective treatment for the events 'had a little leg swelling, baby had been non-stop crying/screaming ever since receiving the vaccines). At time of reporting, the outcome was Recovered Resolved in April 2022 for the event had a little leg swelling and was Recovered / Resolved in April 2022 for the event baby had been non-stop crying/screaming ever since receiving the vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: To correct Suspect Product Coding.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199) at the age of 92 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: diabetes (controlled by diet and exercise no medicine). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received BNT162b2 (BNT162B2) on 27Mar2021 as DOSE 2, SINGLE; Lot Number: ER8730; Anatomical location: left arm), when the patient was 92-year-old, for COVID-19 immunization; The patient also received BNT162b2 (BNT162b2) on 05Jan2022 as DOSE 3 (BOOSTER), SINGLE; Lot Number: 33025BD; Anatomical location: left arm), when the patient was 93-year-old, for COVID-19 immunization.