chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, in her facility where she works at there has been temperature excursions with her freezer. It has been happening for weeks since April 2022.   The storage condition at the time of the excursion was frozen. The vial with lot number affected were 065K21A and 045L21A. The maximum or minimum temperatures reached were as follows maximum: 30 Fahrenheit Degrees and minimum -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The reporter does not have the information on date vial(s) moved from freezer to refrigerator. The vials currently stored in frozen state. On visual inspection no changes were observed in any vaccine state. The Proposed desired Use by Date was not reported.  No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: develop seizures after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (develop seizures after the vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient never had COVID positive test or diagnosis. Patient did not have any acute or chronic illness at the time of vaccination.     On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (develop seizures after the vaccine) (seriousness criterion medically significant). At the time of the report, SEIZURE (develop seizures after the vaccine) was resolving.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient's height was reported as 6 foot 1 inches.   No concomitant medications were reported.  Patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Patient had sought medical care (office visit, Urgent care, ER, hospitalized) due to adverse event.   Patient did not experience similar event in the past.  No treatment  medications were reported.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious, adverse event of special interest Seizure which was medically significant and occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious, adverse event of special interest Seizure which was medically significant and occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Tested positive after eight days; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive after eight days) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 1) and PFIZER BIONTECH COVID-19 VACCINE (Dose 3 (first booster)). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive after eight days) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (Tested positive after eight days) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative on day, positive (Positive) tested positive after eight days and negative (Negative) tested negative on 14.         No Concomitant medication were reported. No treatment drug were reported.  Company Comment: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred on unspecified interval after receiving mRNA-1273 taken as second booster dose of COVID-19 immunization series. Interchange of vaccine products is noted in the case as patient received three doses of Tozinameran prior the mRNA-1273 administration with no adverse event reported.  The clinical course and treatment details were not reported. Repeat COVID-19 test showed negative result. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred on unspecified interval after receiving mRNA-1273 taken as second booster dose of COVID-19 immunization series. Interchange of vaccine products is noted in the case as patient received three doses of Tozinameran prior the mRNA-1273 administration with no adverse event reported.  The clinical course and treatment details were not reported. Repeat COVID-19 test showed negative result. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) 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 there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers 065K21A and 045L21A had undergone temperature excursion.   Maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medication were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 25-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter seems temperature excursions with her freezer in the facility where she works. It was happening for weeks since Apr-2022.  The storage condition at the time of the excursion was reported as frozen storage.  The affected batch lot numbers were reported as 065K21A and 045L21A.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9(-18.9) Fahrenheit degrees.  The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute.  The vials were stored frozen.  Visual inspection did not note any vaccine state change.  Treatment information was not provided.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter informed that in the facility where she worked there had been temperature excursions with her freezer. It happened for weeks since April 2022. She stated that in total there were 49 patients affected, but this number was including the Pfizer vaccines that they had, so she was not sure how many patients were affected and received the Moderna Covid 19 vaccine. The patients received Moderna vaccine in the facility between 21-Apr-2022 to 18-Jun-2022. Storage condition at the time of the excursion was frozen. Expiration dates were unknown and lot numbers included 065K21A and 045L21A. Maximum temperatures reached: 30 Fahrenheit Degrees Minimum temperatures reached -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The vials were now stored in frozen. Visual inspection did not note any vaccine state change. Number of vials/doses impacted was not sure. No treatment information was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna COVID-19 vaccine after temperature excursion; Patients received the Moderna COVID-19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID-19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 vaccine after temperature excursion) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID-19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID-19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that the facility where she worked, there had been temperature excursions with freezer. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus 18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  The vails were stored in frozen state at the time of reporting.  The visual inspection noting any vaccine state change was reported as No  Proposed use by date was reported as No.  No treatment information was reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that the facility where she worked, there had been temperature excursions with freezer. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 degrees Fahrenheit and minimum minus 18.9 degrees Fahrenheit. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  The vials were stored in frozen state. The visual inspection did not noted any vaccine state change.   No treatment information was reported.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 21-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 21-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen. It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively. It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed. No treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna vaccine administered to patients post temperature excursion/patient received moderna vaccine after it had undergone freezing in refrigirator the day before for about a five hours period; 1st dose administered on 05-feb-2022 and 2nd dose administered on 10-may-2022; Poor quality vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion/patient received moderna vaccine after it had undergone freezing in refrigirator the day before for about a five hours period), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-feb-2022 and 2nd dose administered on 10-may-2022) in a 77-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 005M21A and 005M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 10-May-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion/patient received moderna vaccine after it had undergone freezing in refrigirator the day before for about a five hours period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-feb-2022 and 2nd dose administered on 10-may-2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion/patient received moderna vaccine after it had undergone freezing in refrigirator the day before for about a five hours period), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-feb-2022 and 2nd dose administered on 10-may-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that it was a refrigerator excursion where the lowest temperature reached was 26 Fahrenheit for about 15 minutes and the average temperature was 28 Fahrenheit. The entire excursion duration was about 5 hours. Reporter stated that the Moderna vaccine was used post excursion and administered to patients. The patient did not report any adverse effects. The event did not cause the patient to seek medical care.  No treatment medications were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vials were stored at frozen storage at the time of the excursion. The Lot number which were expired are 065K21Aand 045L21A. The vials reached a maximum temperature of 30 Fahrenheit Degrees and minimum of -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  No treatment drug details was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022.Storage condition at the time of the excursion were frozen. It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively. It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and No vaccine state change was observed. No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter informed that in the facility where she worked there had been temperature excursions with her freezer. It happened for weeks since April 2022. She stated that in total there were 49 patients affected, but this number was including the Pfizer vaccines that they had, so she was not sure how many patients were affected and received the Moderna Covid 19 vaccine. The patients received Moderna vaccine in the facility between 21-Apr-2022 to 18-Jun-2022. Storage condition at the time of the excursion was frozen. Expiration dates were unknown and lot numbers included 065K21A and 045L21A. Maximum temperatures reached: 30 Fahrenheit Degrees Minimum temperatures reached -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The vials were now stored in frozen. Visual inspection did not note any vaccine state change. Number of vials/doses impacted was not sure.  No treatment information was reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP reported about temperature excursions with freezer in the facility. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.   The vails were stored in Frozen state.  No treatment information were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during breast feeding, Somnolence
Clinical narrative: sleepy; Tired; Maternal exposure during breastfeeding; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (sleepy), FATIGUE (Tired) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breastfeeding) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: J&J. Past adverse reactions to the above products included No adverse event with J&J.    On 16-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced SOMNOLENCE (sleepy), FATIGUE (Tired) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breastfeeding). On 16-Dec-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breastfeeding) had resolved. At the time of the report, SOMNOLENCE (sleepy) and FATIGUE (Tired) outcome was unknown.            No Concomitant medication was reported.  It was reported that patient had second booster dose from Pfizer on 27-May-2022.  No treatment medication was reported.   This case was linked to MOD-2022-592987 (Parent-Child Link).   See case MOD-2022-592987 for details regarding the child case.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   Reporter informed about temperature excursions with freezer in the facility, where she wored. It had been happening for weeks since April 2022. The storage condition at the time of the excursion was reported as frozen storage.  The affected batch lot numbers were reported as 065K21A and 045L21A.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change.  No treatment medication were provided.   This case was linked to MOD-2022-591989 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Possible AE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Possible AE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Possible AE). At the time of the report, IMMUNISATION REACTION (Possible AE) outcome was unknown.            Concomitant products were not provided. It was reported that patient received second booster. Treatment medications were not reported.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vials were stored at frozen storage at the time of the excursion. The Lot number which were expired are 065K21Aand 045L21A. The vials reached a maximum temperature of 30 Fahrenheit Degrees and minimum of -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  No treatment drug details was reported.