chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: Shortness of breath; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation gas for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included AMBRISENTAN, WARFARIN SODIUM and TADALAFIL (ADCIRCA) for an unknown indication.   On 28-Dec-2017, the patient TREPROSTINIL SODIUM (Nasal) dosage was changed to 0.6 mg/ml, Inhalation. In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (Nasal) at an unspecified dose four times per day. On an unknown date, TREPROSTINIL SODIUM (Nasal) dosage was changed to 42 microgram. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue). At the time of the report, DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A) and the current dose was reported as 30-60 µg (5-10 breaths), four times a day (QID) via inhalation (IH) route. The patient had th events after the COVID (coronavirus disease) vaccine and when using IH Tyvaso. The physician decreased IH Tyvaso to 42 µg (7 breaths) per session. The reporter's causality for the events of fatigue and dyspnoea with IH Tyvaso was considered to be possibly related.  Treatment information was not provided by reporter.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included COBICISTAT, DARUNAVIR ETHANOLATE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (SYMTUZA), HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for HIV disease.   On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 28-Jan-2022, PRODUCT STORAGE ERROR (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 023C21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022 at 7:56 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Feb-2022 at 7:56 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccine). On 08-Feb-2022 at 7:56 AM, EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator - 27Oct2021; 10:45am and the vial was first punctured - 08Feb2022; 7:45am. The vial stored post puncture in room temperature and Total amount of time the vial was exposed to room temperature range (8° to 25°C/46° to 77°F) was 1 hour. No treatment medications were reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was given dose frome expired vial; Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given dose frome expired vial) and PRODUCT STORAGE ERROR (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (under treatment for this illness.).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given dose frome expired vial) and PRODUCT STORAGE ERROR (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient was given dose frome expired vial) and PRODUCT STORAGE ERROR (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-476392 (Patient Link).
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022 at 8:22 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine). On 08-Feb-2022, EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that on 27-Oct-2021 at 10:45 am the date the vial was initially stored in the refrigerator. On 08-Feb-2022 at 7:45 am the vial was first punctured. The vial were stored post puncture at room temperature. The vial was exposed to room temperature range for 1 hour. The vials did not undergo any temperature excursions.  No concomitant and treatment drugs were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Moderna COVD-19 Vaccine that where stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVD-19 Vaccine that where stored in the fridge for more than 30 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (Under treatment for this illness).   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVD-19 Vaccine that where stored in the fridge for more than 30 days). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVD-19 Vaccine that where stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included unspecified treatment for HIV. No treatment medications were reported.   This case was linked to MOD-2022-475781 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Moderna COVD-19 Vaccine from 5 vials that where stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVD-19 Vaccine from 5 vials that where stored in the fridge for more than 30 days) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (Under treatment for this illness). Concomitant products included AMLODIPINE and DOLUTEGRAVIR SODIUM, LAMIVUDINE (DOVATO) for an unknown indication.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVD-19 Vaccine from 5 vials that where stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVD-19 Vaccine from 5 vials that where stored in the fridge for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received unspecified COVID-19 vaccines, first and second dose on 04 May 2021 and 06 Jun 2021 respectively. Vials were moved to the fridge on 28 Dec 2021 for 30 day expiration of 27 Jan 2022.No temperature excursions occurred. No treatment medication were provided.   This case was linked to MOD-2022-475781 (Patient Link).
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022 at 8:23 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Feb-2022 at 8:23 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine). On 08-Feb-2022 at 8:23 AM, EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.            It was reported that patient had no known allergies. Patient had no acute illnesses at the time of vaccination and up to one month before. Patient had no chronic or long-standing health conditions. It was reported that patient was not diagnosed/tested positive for COVID-19. No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2022-455450 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2022 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Feb-2022 at 8:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine). On 08-Feb-2022 at 8:45 AM, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (suffered from neuropathy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced NEUROPATHY PERIPHERAL (suffered from neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (suffered from neuropathy) was resolving. It was reported that, patient suffered from neuropathy since Apr-2021 following a second Moderna vaccine. Patient had been to numerous doctors including a neurologist. Symptoms were lessening but not totally gone. Patient was advised not to get a booster due to adverse reactions. Patient stated that it had been a very long and miserable 10 months. Attempts to reach patient for additional details were unsuccessful. No additional details available at the time of report. No concomitant and treatment medications were provided. Company comment: This spontaneous case concerns patient of unknown age and gender with no reported medical history, who experienced unexpected serious event of Neuropathy peripheral (seriousness criterion Medically significant) which occurred unknown dates after the second dose of mRNA-1273 vaccine. It was reported that, patient suffered from neuropathy since Apr-2021 following a second mRNA1273 vaccine. Patient had been to numerous doctors including a neurologist. Symptoms were lessening but stated that it had been a very long and miserable 10 months. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns patient of unknown age and gender with no reported medical history, who experienced unexpected serious event of Neuropathy peripheral (seriousness criterion Medically significant) which occurred unknown dates after the second dose of mRNA-1273 vaccine. It was reported that, patient suffered from neuropathy since Apr-2021 following a second mRNA1273 vaccine. Patient had been to numerous doctors including a neurologist. Symptoms were lessening but stated that it had been a very long and miserable 10 months. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Product dose omission issue
Clinical narrative: Flu; Did not get the 2nd dose / Greater than 42 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) and PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose / Greater than 42 days after first dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu) and PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose / Greater than 42 days after first dose). At the time of the report, INFLUENZA (Flu) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose / Greater than 42 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  The patient experienced flu (confirmed as not COVID disease). It was reported that the patient did not take the 2nd dose and stated that had to restart the series as per physician recommendation.  No Treatment medication reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (under treatment for this illness).    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was undergoing treatment for HIV. Medications reported included atorvastatin, tivicay and descovy.   Patient did not have any known allergies.   This case was linked to MOD-2022-475923, MOD-2022-476325, MOD-2022-476437 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included DOLUTEGRAVIR SODIUM (TIVICAY), EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) and IVERMECTIN for HIV disease.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drugs were reported.  The patient had no known allergies
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to patients from  vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patients from  vials stored in the fridge for more than 30 days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Dapsone,), Drug allergy (Pentamidine), Drug allergy (Sulfas), Drug allergy (Trimethoprim), Drug allergy (Atorvastatin), Drug allergy (Metformin), Drug allergy (Nelfinavir), Drug allergy (Statins), Allergy to antibiotic (Doxycycline) and HIV infection. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE), EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (ATRIPLA), LORATADINE, ISOSORBIDE MONONITRATE, APIXABAN and CARVEDILOL for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patients from  vials stored in the fridge for more than 30 days). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to patients from  vials stored in the fridge for more than 30 days) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vials were moved to the fridge on 28 Dec 2021 for 30 day expiration of 27 Jan 2022 and the dose was given from the expired vials. The patient was under treatment for HIV illness.  Reporter did not know if any treatment was given to the patient, as she did not know if patient experienced any symptoms after vaccination.   This case was linked to MOD-2022-475781 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (Undergoing treatment for the illness.), Drug allergy (Abacavir allergy) and Drug allergy (Nevirapine allergy). Concomitant products included ATORVASTATIN, COBICISTAT, DARUNAVIR ETHANOLATE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (SYMTUZA) and NICOTINE (NICODERM) for an unknown indication.    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported. HCP stated they administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days. Dates of administration were on 28-Jan-2022, 31-Jan-2022, 01-Feb-2022, 02-Feb-2022 and 07-Feb-2022. All the patients had a clinical history of HIV, and all of them were under treatment for this illness. HCP did not know if any of the patients experienced any symptoms after vaccination. Vials were moved to the fridge on 28-Dec-2021 for 30 day expiration of 27-Jan-2022.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 26 doses of COVID-19 vaccines of moderna were administered past expiration date; 5 vials that where stored in the fridge for more than 30 days.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 doses of COVID-19 vaccines of moderna were administered past expiration date) and PRODUCT STORAGE ERROR (5 vials that where stored in the fridge for more than 30 days.) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (patient was under treatment for this illness.).    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 doses of COVID-19 vaccines of moderna were administered past expiration date) and PRODUCT STORAGE ERROR (5 vials that where stored in the fridge for more than 30 days.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 doses of COVID-19 vaccines of moderna were administered past expiration date) and PRODUCT STORAGE ERROR (5 vials that where stored in the fridge for more than 30 days.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no known allergies. No concomitant medication was provided.  It was reported by Health care professional that they administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that were stored in the fridge for more than 30 days. Vial did not undergo any temperature excursions. Reporter did not know if patient experienced any symptoms after vaccination or any treatment was given to patient.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Product storage error
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days; Patient received 4 doses of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days), PRODUCT STORAGE ERROR (administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days) and EXTRA DOSE ADMINISTERED (Patient received 4 doses of vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Drug allergy and HIV disease. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY), EZETIMIBE, HYDROCHLOROTHIAZIDE, LOSARTAN and FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days), PRODUCT STORAGE ERROR (administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days) and EXTRA DOSE ADMINISTERED (Patient received 4 doses of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days), PRODUCT STORAGE ERROR (administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days) and EXTRA DOSE ADMINISTERED (Patient received 4 doses of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was reported as rosuvastatin.  It was reported that, all the patients had a clinical history of HIV, and all of them were under treatment for this illness.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-476392 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was not known any treatment was given to the patient as the reporter did not know if the patient had experienced any symptoms after vaccination. Vials were moved to the fridge on 28 December 2021 for 30 day expiration on 27 January 2022.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; Date the vial was initially stored in the refrigerator was 28-Dec-2021/ stored in the fridge for more than 30 days.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 28-Dec-2021/ stored in the fridge for more than 30 days.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (Patient was under treatment for this illness). Concomitant products included DOLUTEGRAVIR SODIUM, RILPIVIRINE HYDROCHLORIDE (JULUCA), BUPROPION HYDROCHLORIDE (WELLBUTRIN), ATORVASTATIN CALCIUM (LIPITOR), DOLUTEGRAVIR SODIUM (TIVICAY), SILDENAFIL and DARUNAVIR ETHANOLATE (PREZISTA) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 28-Dec-2021/ stored in the fridge for more than 30 days.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 28-Dec-2021/ stored in the fridge for more than 30 days.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vial did not undergo any temperature excursions  HCP did not know if any treatment was given to the patient, as HCP did not know if the patient experienced any symptoms after vaccination.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to patient from vial stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from vial stored in the fridge for more than 30 days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (patient was under treatment for this illness). Concomitant products included AMLODIPINE and EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) for an unknown indication.  On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from vial stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from vial stored in the fridge for more than 30 days) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient Allergy was not known and date of vaccination were 15-Jan- 2021, 10-Feb-2021, 6-Aug-2021.  The vial was initially stored in the refrigerator on 28-Dec-2021.  It was reported that HCP did not knowif any treatment was given to the patient.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (clinical history of HIV and were under treatment for this illness.). Concomitant products included EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) and DOLUTEGRAVIR SODIUM (TIVICAY) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took primary series of vaccination on 09-March-2021 and 06-April-2021. No treatment information was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (is under treatment for this illness.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  HCP stated they administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days. Dates of administration were on 28Jan2022, 31Jan2022, 1Feb2022, 2fFeb2022 and 7Feb2022. All the patients had a clinical history of HIV, and all of them were under treatment for this illness. The  vials  where stored in the fridge for more than 30 days.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease, Drug allergy (Abacavir), Drug allergy (Lamivudine), Allergy to antibiotic (Sulfamethoxazole), Allergy to antibiotic (Trimethoprim), Drug allergy (Zidovudine), Allergy to antibiotic (Dapson) and Drug allergy (Neviarpine). Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) and ROSUVASTATIN for an unknown indication.    On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vials were moved to fridge on 28-Dec-2021 for 30 day expiration of 27-Jan-2022. Other vaccination dates were 04-May-2021 and  01-Jun-2021.  The patient was on ongoing medications for HIV disease.  No Treatment medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (were under treatment for this illness). Concomitant products included ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ), MELOXICAM (MOBIC), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 02-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided.  Reporter stated they administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for an unknown indication.    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days. on 28-Dec-2021 vials was initially stored in refrigerator. vials did not undergo any temperature excursions. Caller did not know if any of the patients experienced any  symptoms after vaccination.  Reporter stated that All the patients had a clinical history of HIV, and all of them were under treatment for this illness.  Reporter stated did not know if any treatment was given to any of the patients, as she did not know if any of them experienced any symptoms after vaccination.  Patient had no known allergy.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Nurse gave an Expired COVID-19 vaccine Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse gave an Expired COVID-19 vaccine Moderna) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse gave an Expired COVID-19 vaccine Moderna). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse gave an Expired COVID-19 vaccine Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported  Vial was initially stored in the refrigerator on 08-JAN-2022.. Vial didn't undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2022: Follow-up contains Non-Significant information