chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; 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 during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old male 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 2:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   Age of patient was reported as 68.81 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Vial was moved to fridge on 09-Mar-2021. Product moved to clinic on 20-Mar-2021. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit from 09:00 AM to 10:00 AM. Beyond use date for the vial was reported as 08-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; 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 69-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 9:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:08 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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.   Age of patient was reported as 69.41 for dose administered on 27-Oct-2021.  No concomitant medications were reported.  Vial was moved to fridge on 05-Oct-2021. Product moved to clinic on 27-Oct-2021. Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 39, 32 Fahrenheit from 09:00 AM TO 10:00 AM. Beyond use date for the vial was reported as 04-Nov-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 68.0
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 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:47 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, 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.   Age of patient was reported as 68.81 for dose administered on 31-Mar-2021, Vaccination time 1:47 PM. Age of patient was reported as 68.73  for dose administered on 03-March-2021, Vaccination time 3:39 PM.  Concomitant products were not provided.  On 03-Mar-2021 vials were moved to clinic. On 24-Feb-2021 the vaccines were moved to fridge. On 03-Mar-2021, the vial underwent the excursion. The vaccine beyond use date was reported as 26-Mar-2021.  On 31-Mar-2021 vials were moved to clinic. On 30-Mar-2021 the vaccines were moved to fridge. On 31-Mar-2021, the vial underwent the excursion. The vaccine beyond use date was reported as 29-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.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional 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 Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) 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 03-Apr-2021 at 10:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An age of patient was reported as 65.64 for dose administered on 03-Apr-2021.  No concomitant medications were reported. It was reported that for the vial Batch number of 030B21A, it was moved to fridge on 30-Mar-2021 that underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09 AM. The product was moved to clinic on 03-Apr-2021 and beyond use date for the vial was reported as 29-Apr-2021.  The vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration. The vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 67-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 1:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient 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.   Age of patient was reported as 67.47 for dose administered on 03-Nov-2021. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10 AM. This vial was moved to fridge on 05-Oct-2021 and beyond use date for the vial was reported as 05-Nov-2021. Product moved to clinic on 03-Nov-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour. No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
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; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the 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. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021 at 11:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the 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 (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the 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.   Age of patient was reported as 65.52 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 and 37 degrees Fahrenheit from 09:00 AM to 10:00 AM respectively. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 56-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 1:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 56.09 for dose administered on 03-APR-2021. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 03-APR-2021 with temperature 34 Fahrenheit from 09:00 AM. This vial was moved to fridge on 30-MAR-2021 and beyond use date for the vial was reported as 29-APR-2021. Product moved to clinic on 03-APR-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 67-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 31-Mar-2021 at 8:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.72  No concomitant medications were reported. Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 8 AM. This vial was moved to fridge on 23-03-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) in a 68-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 3:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 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 reported as 68.29 for dose administered on 27-Oct-2021.  No concomitant medications were reported. It was reported that for the vial Batch number of 035C21A, it was moved to fridge on 05-Oct-2021 that underwent temperature excursion on 27-Oct-2021 with temperature 32 degrees Fahrenheit at 10 AM and 29 degrees Fahrenheit at 9AM . The product was moved to clinic on 27-Oct-2021 and beyond use date for the vial was reported as 04-Nov-2021.  The vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration. The vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   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: 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 64-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 11:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:41 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, 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 patient age was reported as 64.71 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 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  On 11-Jan-2021, Excursion temperature at 09 am was 34, at 2 pm was 35, total doses given for the day was 98, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021 and 08-Jan-2021, vial was moved to clinic on 08-Jan-2021 and 11-Jan-2021. 2 and 9 vials was moved to clinic. Vaccine BUD date was 04-Feb-2021 and 07-Feb-2021 for batch 041L20A.  Temperature recordings were taken by using a  traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Age: 65.0
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 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 2:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 2:49 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.   Age of patient was reported as 65.28 for dose administered on 12-Jan-2021.  Concomitant products were not provided.  On 12-Jan-2021, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 07-Feb-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 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 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; 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 71-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 10:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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. Not provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 81.66 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 07-Jan-2021, Excursion duration at 9 am: 34, at 10 am 34, at 11 am 36, at 12 am 37, at 1 pm 38, at 2 pm 38, at 3 pm 40, at 4 pm 40.  On 07-Jan-2021, excursion time and temperature at 09, 10 am was 34, 34 respectively, total doses given for the day was 96, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vial was moved to clinic. Vaccine BUD date was 27-Jan-2021.  Temperature recordings were taken by using a  traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; 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 during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-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 10:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   Age of patient was reported as 65.50 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 9:12 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.40 for dose administered on 02-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27,29,32,33,35,36 Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-FEB-2021 and beyond use date for the vial was reported as 26-MAR-2021. Product moved to clinic on 02-MAR-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fall, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted to the hospital due to fall. She required to be placed in observation due to  advanced age, and high fall risk. She tested positive for corona virus disease 19,  she did not have any respiratory symptoms, did not require supplemental oxygen, was given vitamin-C, zinc, vitamin-D.  Seen by Occupational and Physical therapy, felt that she will benefit from skilled nursing facility placement, she was discharged when bed available.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, SARS-CoV-2 test positive, Suicidal ideation
Clinical narrative: Patient was brought by her mother to the hospital for suicidal ideation and mental health evaluation . Patient tested positive for COVID 19, her chest x-ray was normal. Patient did not have any symptoms from her covered positive situation she was not hypoxic on.  She did not require any dexamethasone for any COVID specific medications. Follow up COVID test on 2/8/22 was negative.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray normal, Confusional state, Cough
Clinical narrative: Pt was admitted for generalized weakness, cough, shortness of breath, confusion for 3 days.  He was found COVID-19 positive..  Chest x-ray unremarkable.  Initially, he was hypoxic per record and he was started on oxygen.  He started on steroid and remdesivir. He was eventually stable enough to be discharged.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Pt was admitted for generalized weakness, cough, shortness of breath, confusion for 3 days.  He was found COVID-19 positive..  Chest x-ray unremarkable.  Initially, he was hypoxic per record and he was started on oxygen.  He started on steroid and remdesivir. He was eventually stable enough to be discharged.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough  1st  Dose - 3/24/2021 - Moderna - 007a21b 2snd dose - 4/21/2021 - Moderna - 043b21A
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough 1st - 02/06/2021  Moderna 007M20A   2nd - 03/09/2021 Moderna 023M20A   3rd - 10/26/2021 Moderna 049C21A   4th -- 05/04/2022 Moderna 048L21A
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough  1st - Moderna - 12/23/2020 - No Lot # Provided 2nd - Moderna 1/19/2021 - 012L20A
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient experienced swollen, red, itchy, hot, sore arm around injection site 2 days after injection. Another pharmacist suggested going to Emergency Room and site was confirmed as infected
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient experienced swollen, red, itchy, hot, sore arm around injection site 2 days after injection. Another pharmacist suggested going to Emergency Room and site was confirmed as infected
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Eye irritation, Injection site erythema, Injection site pruritus, Lacrimation increased
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: burning, watery, lack of sensation (can not feel eye drops) in left eye-Medium, Systemic: Weakness-Medium, Additional Details: weakness/lack of energy
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensory loss
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: burning, watery, lack of sensation (can not feel eye drops) in left eye-Medium, Systemic: Weakness-Medium, Additional Details: weakness/lack of energy
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough  1st Dose  2/2/2021 -- EL9265 2nd Dose 2/23/2021 - EN6200
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough  1st Dose  2/2/2021 -- EL9265 2nd Dose 2/23/2021 - EN6200
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Medium
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Medium
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough 1st Dose  2/25/2021 - EN6202 2nd Dose 3/18/2021 - EN6207
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Confirmed Breakthrough 1st Dose  2/25/2021 - EN6202 2nd Dose 3/18/2021 - EN6207