chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
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 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 3:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 3:42 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 42.30 for dose administered on 24-May-2021 at 15:42.  No concomitant medications were reported.  Batch number 026C21A underwent temperature excursion on 24-May-2021 with temperature 35 degrees Fahrenheit between 8AM-9AM. 3 vials of same batch number were moved to fridge on 18-May-2021, moved to clinic on 24-May-2021 and beyond use date for these 3 vials were reported as 17-Jun-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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: severe sore throat; Persistent coughing/virtually with every breath; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Persistent coughing/virtually with every breath) and OROPHARYNGEAL PAIN (severe sore throat) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030A21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Emphysema and Irritable bowel syndrome (IBSD). Concurrent medical conditions included Cholesterol, Hypertension, Penicillin allergy and Allergic reaction to antibiotics (Clindamycin allergy). Concomitant products included ATORVASTATIN CALCIUM from 01-Jan-2021 to 21-May-2022, FLUTICASONE PROPIONATE from 01-Jan-2022 to 21-May-2022, AREDS 2 PLUS MULTI VITAMIN from 01-Jan-2018 to 21-May-2022, PSYLLIUM FIBRE from 01-Jan-2015 to an unknown date and LOPERAMIDE HYDROCHLORIDE from 01-Jan-2021 to an unknown date for an unknown indication.   On 12-Feb-2021 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021 at 1:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Persistent coughing/virtually with every breath). On 21-May-2021 at 11:00 AM, the patient experienced OROPHARYNGEAL PAIN (severe sore throat). At the time of the report, COUGH (Persistent coughing/virtually with every breath) and OROPHARYNGEAL PAIN (severe sore throat) had not resolved.            Patient previously received a COVID-19 Vaccine.  Patient experienced sore throat 6 hours after dosage.  Patient had continued coughing at lesser volume, about every 10-15 minutes, all day and night. It started within one hour of initial dosage.  Treatment information was not provided.  Device date was reported as 23-May-2022.  Pfizer have permission to contact about this report and have permission to contact the patient's healthcare provider.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter  It was reported that the dates of vaccine administration were 3MAY2022, 4MAY2022, 9MAY2022, 11MAY2022, 17MAY2022, and 20MAY2022  Patient was received 2nd booster  No treatment medications were provided by the reporter
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 3 doses of Pfizer as Full dose and then Moderna Booster as Full Dose instead of half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 3 doses of Pfizer as Full dose and then Moderna Booster as Full Dose instead of half dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Dose-2), PFIZER BIONTECH COVID-19 VACCINE (Dose-1) and Pfizer COVID-19 vaccine (Dose-3). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received 3 doses of Pfizer as Full dose and then Moderna Booster as Full Dose instead of half dose). At the time of the report, ACCIDENTAL OVERDOSE (Received 3 doses of Pfizer as Full dose and then Moderna Booster as Full Dose instead of half dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The reporter clarified that the patient was immunocompromised and wanted to get his second dose of booster.  No treatment medication information provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient took 2nd booster.  No treatment medication was reported by reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The patient had received 2nd booster. The dates of administration were 03-May-2022, 04-May-2022, 09-May-2022, 11-May-2022, 17-May-2022, and 20-May-2022.  Treatment information was not reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient had administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient had administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient had administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient had administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that dates of administration were 03 MAY 2022,04 MAY 2022, 09 MAY 2022, 11MAY2022, 17MAY2022, and 20MAY2022.  No treatment medication were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Dates of administration were 3MAY2022, 4MAY2022, 9MAY2022, 11MAY2022, 17MAY2022, and 20MAY2022.  No treatment drug information was provided.   This case was linked to MOD-2022-576251 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter  Patient received second booster dose.  It was reported that the dates of administration were 3MAY2022, 4MAY2022, 9MAY2022, 11MAY2022, 17MAY2022, and 20MAY2022  No treatment medications were provided by the reporter.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient had received 2nd booster.  The dates of administration were 03-May-2022, 04-May-2022, 09-May-2022, 11-May-2022, 17-May-2022, and 20-May-2022.  No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The unpunctured vaccine vial was stored in the refrigerator for 38 days and administered to this patient 8 days after the 30-day Use By Date; Received expired 1st booster dose 8 days after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 1st booster dose 8 days after 30-day Use By Date) and PRODUCT STORAGE ERROR (The unpunctured vaccine vial was stored in the refrigerator for 38 days and administered to this patient 8 days after the 30-day Use By Date) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 1st booster dose 8 days after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The unpunctured vaccine vial was stored in the refrigerator for 38 days and administered to this patient 8 days after the 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 1st booster dose 8 days after 30-day Use By Date) and PRODUCT STORAGE ERROR (The unpunctured vaccine vial was stored in the refrigerator for 38 days and administered to this patient 8 days after the 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter thinks that the patient is in his 60's but not 100 percent sure. No concomitant medications was reported.  Patient received the expired first booster dose of Moderna COVID-19 vaccine.  30-days use by date was reached on 17 May 2022. Vial did not undergo any temperature excursions.  No treatment was reported.
Age: 24.0
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 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 1:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 1:21 AM,  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, 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 24.14.  Concomitant products were not provided.  On 27-Feb-2021 Excursion time and temperature respectively 9AM :33, 11AM: 35, 12 PM : 35, 1PM: 35, 2PM: 35, 3PM: 34, 4PM: 34, 5PM: 35. total doses given for the day was 199, condition of vaccine prior to administration was not frozen,vaccine was moved to fridge on 24-Feb-2021.vial was moved to clinic on 27-Feb-2021,20 vials were sent to clinic.Vaccine BUD date was 26-Mar-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively 9 AM: 33, 10AM :36, 11 AM: 35, 12 PM :35, 1PM: 35, 2PM :35, 3PM :34, 4 PM : 34, 5PM :35.  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: 24.0
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 24-year-old female 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 2:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:55 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 24.60.  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, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 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 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: 30.0
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 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 11:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). On 22-Jun-2021 at 11:11 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (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 30.31.  Concomitant products were not provided.  On 22-Jun-2021, excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021.  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43 and 5 PM: not provided.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a 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: 52.0
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 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:35 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.02.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time and temperature were 09AM: 34 and 10 AM: 37 respectively. total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021 and vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021. On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44 , 4 PM: 44 and 5 PM: 43. 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: 18.0
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 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 an 18-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 07-Jan-2021 at 9:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 9:58 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). 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 18.88.  Concomitant products were not provided.  On 07-Jan-2021, Excursion time and temperature were 09AM: 34 and 10 AM: 34 respectively. total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021 and vial was moved to clinic on 07-Jan-2021. 06 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: 53.0
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 53-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 11:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (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.   Concomitant products were not provided.  The age of patient was provided as 53.02.  On 20-Mar-2021, Excursion time was 09 AM, temperature was 34, 10 AM temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM 43.  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: 32.0
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 32-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 4:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:39 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 32.03 years  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, 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: 45.0
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 45-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-2021 at 9:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 9:33 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 reported as 45.95.  Concomitant products were not provided.  On 14-Feb-2021, at excursion time 09 AM, temperature was 32, at 10 AM temperature was 32, at 11 AM temperature was 32, at 2 PM temperature was 35 and at 3 PM temperature was 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 9-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-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: 22.0
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 22-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 13-Feb-2021 at 2:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 2:16 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, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.95.  Concomitant products were not provided.   On 13-Feb-2021, at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit and vial was initially moved to the fridge on 09-Feb-2021 and beyond use date was 10-Mar-2021. Product moved to clinic on 13-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 traceable temperature monitor at every hour. 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: 33.0
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 33-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 13-Feb-2021 at 1:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:08 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 33.74. Concomitant products were not provided. On 13-Feb-2021, Excursion time was 09 AM, with temperature as 32. Total doses given for the day was 152 vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 09-Feb-2021 and. Vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. On 13-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 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.