chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.; Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.) In a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient did not have COVID-19 preceding the month of vaccination.  No allergies were reported.  Concurrent medical conditions included Hypertension, Diabetes mellitus, Hyperlipidemia and Chronic kidney disease.    On 01-Apr-2022 at 10:18 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 10:18 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.Vial didn't undergo any temperature excursions.  Patient did not experience any side effects yet.  Concomitant drugs were not reported.  Treatment details were not given.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine on 06-Apr-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine on 06-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. The patient had never been diagnosed with or tested positive for COVID-19. The vial did not undergo any temperature excursions. There were no adverse events from the vaccine. The vaccine had an expiry date of 18-Mar-2022 but the Moderna stability study showed the vaccine was active against COVID-19. No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022; doses administered after 30-day Use By Date and after expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and after expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known meds/food allergies. The patient had no chronic/acute illness.     On 06-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and after expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and after expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient had not received any daily medications.  The vial was initially stored in the refrigerator on 25-Feb-2022. Expiration date for vaccine 25-Mar-2022. The vial did not undergo any temperature excursions. It was reported that the patient not experienced any side effect.  No treatment information was reported.  Patient had not tested COVID-19 within last month.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initial stored in refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; 36 doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initial stored in refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initial stored in refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initial stored in refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. It was reported that date the vial was initially stored in the refrigerator was 25-FEB-2022. Vial didn't undergo any temperature excursions. Patient did not experienced any side effects yet. No Treatment information was reported.   This case was linked to MOD-2022-545267 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-MAR-2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-MAR-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Allergies included no known drug allergies.  Concurrent medical conditions included Type 2 diabetes mellitus and Hypertension.    On 30-Mar-2022 at 10:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022 at 10:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient took Diabetes 2 and hypertension medications. On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022. The vial did not undergo any temperature excursions. It was reported that the patient not experienced any side effect. No treatment information was reported. The patient not had COVID-19 within last month.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.; Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient did not have COVID-19 preceding the month of vaccination.  No allergies nor any Acute and Chronic illness was reported.     On 01-Apr-2022 at 10:59 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 10:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022. Vial did not undergo any temperature excursions. Patient did not experience any side effects yet. Concomitant drugs were not reported. Treatment details were not given.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022; Doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No known drug allergy was reported.  Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESART AND HYDROCHLOROTHIAZIDE), AMLODIPINE, METOPROLOL, FAMOTIDINE (PEPCID [FAMOTIDINE]) and CETIRIZINE HYDROCHLORIDE (CITIRIZINE [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 30-Mar-2022 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 25-FEB-2022 Vial didn't undergo any temperature excursions. Patient had not experienced any side effects yet. No treatment details were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA [DILTIAZEM HYDROCHLORIDE]), METFORMIN, METOPROLOL, DILTIAZEM and LOVASTATIN for an unknown indication.    On 20-Apr-2022 at 11:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 11:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had any allergies to food or medications.  Total number of doses/vials was 36.  Vial did not undergo any temperature excursions. Patient not experienced any side effects yet.   No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 30 Mar 2022) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. Patient had no known drug allergy or medication of food allergy. Concurrent medical conditions included Type 2 diabetes mellitus, Hyperglyceridemia, Hypertension, Chest pain and Dorsalgia. Concomitant products included Esomeprazole; Atorvastatin; Amlodipine; Aspirin; Losartan; Metformin; Triamcinolone for an unknown indication. On 30-Mar-2022 at 9:59 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022 at 9:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 30 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 30 Mar 2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had other medication such as Omicron. Dose administered past the 30 day storage on the refrigerator. Number of doses or vials administered 36 doses. Date and time the vial was initially stored in the refrigerator 25 Feb 2022. The vial had not undergone any temperature excursion. Covid positive or negative within last month was reported as N. No treatment medications were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 immunisation.     Patient was not allergic to medicine/food. Patient had no acute/chronic illnesses.     On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any concomitant medication.  Patient received booster dose of Moderna vaccine.  On 25-Feb-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Patient did not experience any side effects yet.  No treatment medication was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient did not had COVID-19 preceding month of vaccination. Patient had no known allergies of medicines and food.  Concurrent medical conditions included Hyperlipidemia. Concomitant products included ASA, VALACYCLOVIR [VALACICLOVIR] and ATORVASTATIN for an unknown indication.    On 06-Apr-2022 at 3:07 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022. The vial did not undergo any temperature excursions. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Patient received expired dose of Moderna COVID-19 Vaccine; Patient received 0.5 ml 4th dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 Vaccine) and ACCIDENTAL OVERDOSE (Patient received 0.5 ml 4th dose of Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     The patient had no known allergies and was not diagnosed/tested positive for COVID-19. The patient had no chronic conditions or long lasting heath conditions and not had acute illness at the time of vaccination and up to one month before.     On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 Vaccine) and ACCIDENTAL OVERDOSE (Patient received 0.5 ml 4th dose of Moderna COVID-19 Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 Vaccine) and ACCIDENTAL OVERDOSE (Patient received 0.5 ml 4th dose of Moderna COVID-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The number of doses/vials was 28. The date of the vials initially stored in the refrigerator was unknown. The vials did not undergo any temperature excursions. The frequency was reported as times per. The patient had not experienced any adverse event.  No treatment medications were reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022; 36 doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included LISINOPRIL, ZOLPIDEM and DICLOFENAC for an unknown indication.    On 06-Apr-2022 at 8:56 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 8:56 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that HCP confirmed the patients did not experience any side effects yet.  On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022 and expired. The vial did not undergo any temperature excursions.  Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. The patient had no known drug allergies. Concurrent medical conditions included Asthma. Concomitant products included Melatonin; Acyclovir [Aciclovir]; Albuterol Sulfate for an unknown indication. On 20-Apr-2022 at 11:43 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 11:43 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vial was initially stored in refrigerator on 25-Feb-2022. The vial did not undergo temperature excursion. It was reported that the patient was vaccinated post 30 day use period (expiration date 25-Mar-2022). The patient did not experience any side effects. No treatment details were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 20-Apr-2022; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 20-Apr-2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL and HCTZ for an unknown indication.    On 20-Apr-2022 at 11:27 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 11:27 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 20-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine expiration date was 25-Mar-2022. The date and time the vial was initially stored in the refrigerator was on 25-Feb-2022. The vial did not undergo any temperature excursions. The patient had not experienced any side effects yet. Treatment medications were not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; Dose administered after 30-day Use By Date/vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypocalcemia. Concomitant products included IBUPROFEN, FLUCONAZOLE, FLUTICASONE PROPIONATE and OMEPRAZOLE for an unknown indication.    On 13-Apr-2022 at 1:46 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 1:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any known allergies. On 25-Feb-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Patient did not experience any side effects yet. No treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A .) for COVID-19 vaccination.     Concurrent medical conditions included Leiomyoma of uterus, unspecified and Drug allergy (CHLOROQUINE allergy). Concomitant products included PROPRANOLOL, IBUPROFEN, NORETHINDRONE [NORETHISTERONE] and LOSARTAN for an unknown indication.    On 06-Apr-2022 at 10:16 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 10:16 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022. The vial did not undergo any temperature excursions. No Treatment information was reported
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.            No concomitant medications reported. No treatment reported.  Company Comment: This is a Spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the expected, serious (medically significant), and AESI of Myocarditis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-546789 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the expected, serious (medically significant), and AESI of Myocarditis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergies or food and none daily medications were reported. Positive or negative COVID-19 within last month of vaccination was not applicable.  Concurrent medical conditions included Hyperlipidemia and Bipolar disorder (Bipolar).    On 06-Apr-2022 at 9:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 9:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.  Patient received a vaccine past the 30-day storage on the refrigerator. The Moderna vaccine in question had been put aside and was not currently being used until further notice.  The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 06-Apr-2022 (administered after 30-day Use By Date). Vial did not undergo any temperature excursions.  The patient was not experiencing any side effects yet.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no allergies, acute/chronic illnesses and daily medications. Patient not tested positive for COVID within last month.     On 13-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The product expiration date was 25 Mar 2022.   It was reported that HCP confirmed the patients did not experience any side effects yet.  On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022 and expired. The vial did not undergo any temperature excursions.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022; Patient was administered vaccine after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia and Glaucoma. Concomitant products included GABAPENTIN, LOVASTATIN and LISINOPRIL for an unknown indication.    On 20-Apr-2022 at 8:49 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 8:49 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had any allergies to food or medications. Patient did not had COVID-19 positive or negative preceding month of vaccination.  Total number of doses/vials was 36. Vial did not undergo any temperature excursions. Patient not experienced any side effects yet.  No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 06-Apr-2022; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 06-Apr-2022) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), IBUPROFEN, VITAMIN D3, CETIRIZINE and ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for an unknown indication.    On 06-Apr-2022 at 10:32 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 10:32 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The expiration date was 25 Mar 2022. Date and time the vial was initially stored in the refrigerator on 25 Feb 2022. No treatment medication information provided. Covid positive or negative within last month was reported as No.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had Statin allergy, Amlodipine Allergy and Ezetimibe Allergy.  It was unknown if the patient tested positive/negative for COVID-19 within last month.  Concurrent medical conditions included Drug allergy, Diabetes, Drug allergy and Drug allergy. Concomitant products included TRIAMCINOLONE, ESCITALOPRAM, IBUPROFEN, LORATADINE, ASA, LORAZEPAM, PRAZOSIN, ALBUTEROL SULFATE, BENZONATATE, FLUTICASONE, LOSARTAN, NIFEDIPINE and MUPIROCIN for an unknown indication.    On 06-Apr-2022 at 9:31 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 9:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not COVID-19 positive within last month.  The number of doses/vials was 36.  On 25-Feb-2022, the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Patient did not experience any side effects at the time of report.  No Treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash erythematous, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: The rash was sore and warm to touch; Within 24 hours she had a huge red rash the size of a baseball on her left arm; The rash was sore; Within 24 hours she had a huge red rash the size of a baseball on her left arm; fatigue for 24 hours after her second shot. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The rash was sore and warm to touch), RASH ERYTHEMATOUS (Within 24 hours she had a huge red rash the size of a baseball on her left arm), VACCINATION SITE PAIN (The rash was sore), VACCINATION SITE RASH (Within 24 hours she had a huge red rash the size of a baseball on her left arm) and FATIGUE (fatigue for 24 hours after her second shot.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Hives (hives from Iodine contrast dyes and other sources). Concurrent medical conditions included Iodine contrast media allergy (hives from Iodine contrast dyes and other sources.).    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced FATIGUE (fatigue for 24 hours after her second shot.). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (The rash was sore and warm to touch), RASH ERYTHEMATOUS (Within 24 hours she had a huge red rash the size of a baseball on her left arm), VACCINATION SITE PAIN (The rash was sore) and VACCINATION SITE RASH (Within 24 hours she had a huge red rash the size of a baseball on her left arm). In January 2021, FATIGUE (fatigue for 24 hours after her second shot.) had resolved. On 09-Feb-2021, VACCINATION SITE PAIN (The rash was sore) and VACCINATION SITE RASH (Within 24 hours she had a huge red rash the size of a baseball on her left arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (The rash was sore and warm to touch) outcome was unknown and RASH ERYTHEMATOUS (Within 24 hours she had a huge red rash the size of a baseball on her left arm) had resolved.            No concomitant medications were reported.  The patient received her second Moderna Covid-19 vaccine and expiration date is not available. The patient received the vaccine in her left arm shoulder deltoid muscle.   It was reported that within 24 hours patient had a huge red rash the size of a baseball on her left arm. The rash was sore and warm to the touch. The rash lasted for 2 weeks. The patient had fatigue for 24 hours after her second shot.   No treatment details were reported.   This case was linked to MOD-2022-546786, MOD-2022-546931, MOD-2022-546935, MOD-2022-546503 (Patient Link).