chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended), POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended), POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended).    No concomitant product use was reported.  HCP stated the temperature happed on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.  No symptoms were reported after the administration of the vaccine.  No treatment information was provided.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. As1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended).    Patient age was reported as 2 years and 10 months.  Concomitant product use was not provided by the reporter.  HCP stated that the temperature happened on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.   No symptoms were reported after the administration of the vaccine.  Treatment information was not provided.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended), POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended), POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended).    Patient age reported as 7 Year and 11 Months. No concomitant medication information provided  Reporter stated that the duration of the excursions was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials was still frozen after the excursion.  It was reported that there were no adverse reactions to the Covid vaccines given and it was determined even though there was a temperature excursion one time that the vaccines was still viable and can be used until the end of the day on 17-Aug-2022.   No treatment medications were reported.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine that had undergone temperature excursion issue; No symptoms were reported after administration of vaccine; Patient was administered with vaccine that had undergone temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. As1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue).    No concomitant medications were reported.  It was reported that excursion happened on 18-Jul-2022 for two and half hours and the maximum temperature reached was 8.76 °C and minimum temperature reached was -4.5°C. The vials were still frozen after excursion.  It was determined even though there was a temperature excursion one time that the vaccines was still viable and can be used until the end of the expiration day.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient was tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient was tested positive for COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045BZ1A) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteoarthritis since 1985 and Hypothyroidism since 1995. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, CELECOXIB for Osteoarthritis, RALOXIFENE for Prophylaxis, VITAMIN C [ASCORBIC ACID] and NIZATIDINE (PROTIN) for an unknown indication.    On 18-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced COVID-19 (Patient was tested positive for COVID-19). At the time of the report, COVID-19 (Patient was tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 test: (Positive) Yes, patient was diagnosed or tested positive for COVID-19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient had not had acute illness at the time of vaccination and up to one month.  No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a 63-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result 10 days after the first dose of the 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 event was unknown. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-324206 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 63-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result 10 days after the first dose of the 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 event was unknown. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. As1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended).    Patient age was reported as 1 year and 4 months.  No concomitant product use was reported.  HCP stated the temperature happed on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.   No symptoms were reported after the administration of the vaccine.  No treatment information was provided.   This case was linked to MOD-2022-624878 (E2B Linked Report).; Sender's Comments:  MOD-2022-624878:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient was administered a lower than authorized dose of the Moderna booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022, the patient experienced UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna booster).    No concomitant product use was provided.  On 10-Aug-2022, the patient received a 0.25 mL dose from the dark blue cap with the purple border, instead of 50 mcg/0.50 mL dose.   The patient had not reported any adverse reactions to this dose yet.   No treatment medication was provided.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine that had undergone temperature excursion issue; No symptoms were reported after administration of vaccine; Patient was administered with vaccine that had undergone temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue) and NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No symptoms were reported after administration of vaccine) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion issue).    Patient age was reported as 8 years 3 months.  No concomitant medications were reported.  It was reported that excursion happened on 18-Jul-2022 for two and half hours and the, maximum temperature reached was 8.76 degree celsius and minimum temperature reached was -4.5 degree celsius. The vials were still frozen after excursion.  It was determined even though there was a temperature excursion one time that the vaccines was still viable and can be used until the end of the expiration day on 17-Aug-2022.  No treatment medications were reported.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J Vaccine (Dose number: 2LOT number:unknown), J&J Vaccine (Dose number : 1 and LOT number:unknown). Past adverse reactions to the above products included No adverse reaction with J&J Vaccine and J&J Vaccine.    On 26-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 vaccine).    No concomitant medications were reported.  It was reported that the vial had not undergone any temperature excursions.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was stored more than 12 hours post puncture; no adverse event; Dose administered  more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered  more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was stored more than 12 hours post puncture) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Aug-2022 at 9:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Aug-2022 at 9:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered  more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored more than 12 hours post puncture) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered  more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was stored more than 12 hours post puncture) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered  more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was stored more than 12 hours post puncture).    Concomitant product use was not provided by the reporter.  Date the vials was initially stored in refrigerator was 03-Aug-2022.  Vials was first punctured on 10-Aug-2022 at 10:45 am.  The patient received vaccine on 11-Aug-2022  at 09:05 am.  Vials was stored in fridge post puncture.  Vials did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 30 minutes.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-628730, US-MODERNATX, INC.-MOD-2022-628730 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628730:Case for adult Patient 2 of 2
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired doses of Moderna Covid-19 vaccine was given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna Covid-19 vaccine was given) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna Covid-19 vaccine was given). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna Covid-19 vaccine was given) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna Covid-19 vaccine was given).    No concomitant medications were reported.  It was unknown if patient experienced any allergies to (medications, food and other products). It was unknown if patient had COVID positive test or diagnosis. History relating to mentioned AE and both acute and chronic illnesses at the time of vaccination was unknown. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose) was unknown. It was unknown if AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). It was unknown if patient experienced a similar event in the past. It was reported that the vial had not undergone any temperature excursions.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM; No adverse event; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2022 at 9:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Aug-2022 at 9:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 10-AUG-2022 10:45 AM and administered on 11-AUG-2022 09:05 AM).    This case contains information for the 2nd of two adult patients as described by the reporter.   No concomitant medications were reported. Number of doses/vial were 2 doses/1vial.  On 03-Aug-2022 the vial was initially stored in refrigerator. Vials was stored in fridge post puncture.  Vials did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius = 46 to 77 degree Fahrenheit) was 30 minutes.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2022-628728 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628728:Case for adult Patient 1 of 2
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended).    No concomitant product use was reported.  Patient age was reported as 02 years and 11 months.  HCP stated the temperature happed on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.   No symptoms were reported after the administration of the vaccine.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Approximately 500 doses were administered from vaccine stored in Household freezer.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Approximately 500 doses were administered from vaccine stored in Household freezer.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Approximately 500 doses were administered from vaccine stored in Household freezer.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Approximately 500 doses were administered from vaccine stored in Household freezer.) and NO ADVERSE EVENT (No adverse event) 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 stated that they had been giving moderna vaccines exclusively 1.5years ago, starting the beginning of 2021. No treatment medications were reported.  On 16-Aug-2022, case MOD-2022-628739 became invalid as it was confirmed that no patient identifier was reported.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022; No adverse event; administered dose 10 days expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose 10 days expired), PRODUCT STORAGE ERROR (Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Aug-2022 at 4:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose 10 days expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered dose 10 days expired), PRODUCT STORAGE ERROR (Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered dose 10 days expired) and PRODUCT STORAGE ERROR (Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022).    The vial was initially stored in the refrigerator on 01-Jul-2022. The vial did not undergo any temperature excursion. No concomitant medications were reported. No treatment  medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administer the vaccine to two patients on 20Jul2022, after leaving  it at a room temperature on the 19Jul2022).    Th e patient was a pediatric patient. Number of doses or vials 2 doses. The vial was initially stored in the refrigerator was unknown. The vial was first punctured on 19 Jul 2022 at 9.45 am. The vial was stored in room temperature post puncture. The vial was exposed to room temperature range for 24 hours.  No concomitant medications was reported. No treatment medications was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Tinnitus
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (noticed ringing in her ears), FEELING ABNORMAL (immediately after she got the first shot, she felt kind of not herself/ she have shrunk) and DIZZINESS (little light headed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A, 038B21A and 021C21A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs). Concomitant products included COLECALCIFEROL (VITAMIN D3) and CALCIUM for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (immediately after she got the first shot, she felt kind of not herself/ she have shrunk) and DIZZINESS (little light headed). In April 2021, the patient experienced TINNITUS (noticed ringing in her ears). On 10-Mar-2021, FEELING ABNORMAL (immediately after she got the first shot, she felt kind of not herself/ she have shrunk) and DIZZINESS (little light headed) had resolved. At the time of the report, TINNITUS (noticed ringing in her ears) was resolving. No treatment information was provided. Height: 5'2.5" (patient says that she used to be 5'4" but has shrunk). Patient noticed after a month or so of receiving the shot that she was experiencing ringing in her ears. She said that the ringing was periodic, but annoying because she noticed it and knows that it was happening. She said that there had been a slight improvement in her symptoms since it first started and that the ringing had become a little less as days go by. She will be seeing an ENT this month to find out why she was experiencing the ringing in her ears. She also stated that immediately after she received the first shot she felt not herself and a little lightheaded. She felt like she needed to sit down and was glad she was told to stay for 20 minutes after the shot. This feeling lasted for an hour after which she started feeling normal again. She said that she has never had this experience with any other vaccines.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Received expired booster dose after 30-day Use By Date; Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired booster dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time).    Concomitant product use was not provided by the reporter. It was reported that there were total 2 vials and 8 doses were affected. The vials did not undergo any temperature excursion and were in refrigerator the entire time. The vaccine doses were administered to 4 patients on 22-Jul-2022 and to 4 patients on 02-Aug-2022. The vials were in refrigerator the entire time. Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: severe pain in the muscles right arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (severe pain in the muscles right arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078J21A, 011M20A and 011A21A) for COVID-19 prophylaxis.     Patient does not had a history of Myocarditis and Pericarditis. Patient does not had a history of Covid-19 infection.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (severe pain in the muscles right arm). At the time of the report, MYALGIA (severe pain in the muscles right arm) outcome was unknown.            No concomitant medications were reported. The patient did not have a history of Myocarditis and Pericarditis. Patient did not have a history of Covid-19 infection Patient's Cardiac Symptoms started after his second Primary series and were ongoing. Patient received third dose as a booster dose. No treatment medications were reported.   This case was linked to MOD-2021-220435 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: COVID arm; Patient experienced injection site reaction including swelling.; Patient experienced injection site reaction including redness; Patient experienced injection site reaction including soreness.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (COVID arm), VACCINATION SITE SWELLING (Patient experienced injection site reaction including swelling.), VACCINATION SITE ERYTHEMA (Patient experienced injection site reaction including redness) and VACCINATION SITE PAIN (Patient experienced injection site reaction including soreness.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.   It was reported allergies of patient was unknown.  It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.  It was unknown whether patient has diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Diverticulitis (Worsening for the last 5 years). Concomitant products included CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Patient experienced injection site reaction including swelling.), VACCINATION SITE ERYTHEMA (Patient experienced injection site reaction including redness) and VACCINATION SITE PAIN (Patient experienced injection site reaction including soreness.). On 05-Feb-2021, the patient experienced IMMUNISATION REACTION (COVID arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination adverse reaction, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (COVID arm) outcome was unknown and VACCINATION SITE SWELLING (Patient experienced injection site reaction including swelling.), VACCINATION SITE ERYTHEMA (Patient experienced injection site reaction including redness) and VACCINATION SITE PAIN (Patient experienced injection site reaction including soreness.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received no other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Patient stated that patient experienced wild reactions.  The patient did not experienced similar events in the past.   This case was linked to MOD-2022-628837, MOD-2022-628840 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia, Vaccination site erythema, Vaccination site reaction
Clinical narrative: COVID arm; Patient experienced injection site reaction including swelling.; Patient experienced injection site reaction including redness; Patient experienced injection site reaction including soreness.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (COVID arm), VACCINATION SITE SWELLING (Patient experienced injection site reaction including swelling.), VACCINATION SITE ERYTHEMA (Patient experienced injection site reaction including redness) and VACCINATION SITE PAIN (Patient experienced injection site reaction including soreness.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.   It was reported allergies of patient was unknown.  It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.  It was unknown whether patient has diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Diverticulitis (Worsening for the last 5 years). Concomitant products included CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Patient experienced injection site reaction including swelling.), VACCINATION SITE ERYTHEMA (Patient experienced injection site reaction including redness) and VACCINATION SITE PAIN (Patient experienced injection site reaction including soreness.). On 05-Feb-2021, the patient experienced IMMUNISATION REACTION (COVID arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination adverse reaction, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (COVID arm) outcome was unknown and VACCINATION SITE SWELLING (Patient experienced injection site reaction including swelling.), VACCINATION SITE ERYTHEMA (Patient experienced injection site reaction including redness) and VACCINATION SITE PAIN (Patient experienced injection site reaction including soreness.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received no other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Patient stated that patient experienced wild reactions.  The patient did not experienced similar events in the past.   This case was linked to MOD-2022-628837, MOD-2022-628840 (Patient Link).