chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 14-Mar-2022 and administration of expired vaccine on 07-April-2022; received expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Mar-2022 and administration of expired vaccine on 07-April-2022) in a 47-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 068h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Mar-2022 and administration of expired vaccine on 07-April-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired dose) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-Mar-2022 and administration of expired vaccine on 07-April-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported The vial was initially stored in the refrigerator on 14-Mar-2022. No temperature excursion. No treatment drugs were reported.   This case was linked to MOD-2022-535994 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Follow-up received included reporter correct name and date of initially stored in the refrigerator updated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 11-Apr-2022, MOD-2022-536025 considered invalid as no individual patient information reported. Concomitant medications were not reported. No other side effects were reported by the reporter. Treatment information was not reported.  It was reported that the analysis of the vials associated with storage excursion was complete. The vaccine administered on April 5, 2022, April 6, 2022 and April 7, 2022 from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.   This case was linked to MOD-2022-538271, MOD-2022-538141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Significant Follow up was received. Patient Identifiers, Date of birth, dosage information was updated. On 11-Apr-2022: Non significant follow up: Analysis added
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine moved to fridge on administration date. The vial did not undergone any temperature excursions. There were no adverse events reported by the patients after the administration error. No Concomitant medication information was reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Added Patient demographics, Lot number, date of administration and Added dose number.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic valve stenosis, Chills
Clinical narrative: Valve stenosis from minor to moderate/severe; Chills; This spontaneous case was reported by a nurse and describes the occurrence of AORTIC VALVE STENOSIS (Valve stenosis from minor to moderate/severe) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient had many allergies to medicines and products but did not specify which ones.), Stenosis aortic valve (Patient had a cardiac aortic valve stenosis prior vaccination and After vaccination she went to her Doctor and noticed that it went from minor to moderate/severe condition. Doctor said it happens with age and did not attribute it to vaccine.) and Thyroid disorder (She had a thyroid condition prior vaccination.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and PRAVASTATIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-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 AORTIC VALVE STENOSIS (Valve stenosis from minor to moderate/severe) and CHILLS (Chills). At the time of the report, AORTIC VALVE STENOSIS (Valve stenosis from minor to moderate/severe) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered AORTIC VALVE STENOSIS (Valve stenosis from minor to moderate/severe) to be not related. No further causality assessment was provided for CHILLS (Chills).    Treatment information was not provided.   This case was linked to MOD-2022-536287.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 004C21A, 013L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (crab), COPD, Chronic kidney disease (Chronic Kidney disease stages (3b-4)), Hypertension, Hyperlipidemia, Diabetes, Anemia, Diverticulitis, Neuropathy and Cardiomegaly. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), TRIAMCINOLONE, VALACICLOVIR HYDROCHLORIDE (VALTREX), EZETIMIBE (ZETIA), LISINOPRIL DIHYDRATE (PRINIVIL), PREDNISONE, METOPROLOL TARTRATE (LOPRESSOR) and DICLOFENAC SODIUM (ANODYNE [DICLOFENAC SODIUM]) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received second booster dose on 07-APR-2022. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-536072 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose-1, Date administered: 23Dec2020, Dose-2,Date administered: 28Jan2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1, Date administered: 23Dec2020, Dose-2,Date administered: 28Jan2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (crab), COPD, Chronic kidney disease (Chronic Kidney disease stages (3b-4)), Hypertension, Hyperlipidemia, Diabetes, Anemia, Diverticulitis, Neuropathy and Cardiomegaly. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), TRIAMCINOLONE, VALACICLOVIR HYDROCHLORIDE (VALTREX), EZETIMIBE (ZETIA), LISINOPRIL DIHYDRATE (PRINIVIL), PREDNISONE, METOPROLOL TARTRATE (LOPRESSOR) and DICLOFENAC SODIUM (ANODYNE [DICLOFENAC SODIUM]) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1, Date administered: 23Dec2020, Dose-2,Date administered: 28Jan2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1, Date administered: 23Dec2020, Dose-2,Date administered: 28Jan2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had not done Covid test and no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No treatment information was provided.   This case was linked to MOD-2022-536022 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired product moved to fridge on date of administration; administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the published expiration date) and PRODUCT STORAGE ERROR (Expired product moved to fridge on date of administration) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the published expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired product moved to fridge on date of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the published expiration date) and PRODUCT STORAGE ERROR (Expired product moved to fridge on date of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The published expiration date was reported as 25-Mar-2022. The vial was moved to the fridge on the day of administration. The vial did not undergo temperature excursion.   There were no adverse events reported by the patient after the administration error.  No concomitant medications were reported.  No treatment information was reported.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait inability, Incorrect dose administered, Syncope, Vaccination site pain
Clinical narrative: Syncope event; Typical arm pain; could not stand or walk; could not stand or walk/slid down to the floor; Received a full booster dose of 0.5 mL; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Syncope event), GAIT INABILITY (could not stand or walk), DYSSTASIA (could not stand or walk/slid down to the floor), VACCINATION SITE PAIN (Typical arm pain) and INCORRECT DOSE ADMINISTERED (Received a full booster dose of 0.5 mL) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Apr-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received a full booster dose of 0.5 mL). On 06-Apr-2022, the patient experienced GAIT INABILITY (could not stand or walk) and DYSSTASIA (could not stand or walk/slid down to the floor). On an unknown date, the patient experienced SYNCOPE (Syncope event) and VACCINATION SITE PAIN (Typical arm pain). At the time of the report, SYNCOPE (Syncope event), GAIT INABILITY (could not stand or walk), DYSSTASIA (could not stand or walk/slid down to the floor), VACCINATION SITE PAIN (Typical arm pain) and INCORRECT DOSE ADMINISTERED (Received a full booster dose of 0.5 mL) outcome was unknown.            Concomitant and Treatment product use was not provided by the reporter.  Details of the initial doses of COVID-19 vaccination was reported by the reporter. It was stated as, the patient received second booster dose of the Moderna COVID-19 vaccine on 05 Apr 2022 in her right arm and experienced a severe reaction. On next day of vaccination, the patient could not stand or walk. It was a syncope event, she slid down to the floor. She also reported typical arm pain. Patient had to call the EMT because reporter was not sure what was happening. The reporter stated that patient received a full booster dose of 0.5 mL, and was unsure if that was okay.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: She doesn't think her 2nd booster dose  was 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (She doesn't think her 2nd booster dose  was 0.25 ml) 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 an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (She doesn't think her 2nd booster dose  was 0.25 ml). At the time of the report, PRODUCT ADMINISTRATION ERROR (She doesn't think her 2nd booster dose  was 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Patient received 4 shots of Moderna COVID-19 vaccine (2 primary doses and 2 boosters). Patient reported that the 2nd booster dose with start date year stated as 2022 didn't looked like 0.25ML. Nurse reported that the HCP refused to show the vial and told her 2.5ml but immediately corrected and informed as0.25ml. No treatment details were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vial was moved to fridge on the date of administration. The vial did not undergo temperature excursions. No adverse events reported by the patient after the administration error.  No treatment medication was provided.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a couple of days) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939402 and 040C21A) for COVID-19 vaccination.     It was reported that the patient had never been diagnosed with/tested positive for COVID-19.  Patient was not given any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Nervous (hold a glass of water). Concurrent medical conditions included Penicillin allergy (Penicillin), Contrast media allergy (Allergy to X-ray dyes), Mitral valve prolapse (start date : all life), Hypertension (35 years ago), Cholesterol and Anxiety (hold a glass of water). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Allergy, DIAZEPAM (VALIUM) for Anxiety, SIMVASTATIN for Cholesterol, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hypersensitivity, DILTIAZEM for Mitral valve prolapse, VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a couple of days). On 29-Aug-2021, PAIN IN EXTREMITY (sore arm for a couple of days) had resolved.            No treatment information was provided.   This case was linked to MOD-2022-536137, MOD-2022-536174 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Patient did not had any COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy, Contrast media allergy (Allergy to X-ray dyes), Mitral valve prolapse (start date : all life), Blood pressure high (35 years ago) and Cholesterol. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST SODIUM (SINGULAIR) for Allergy, DIAZEPAM (VALIUM) for Anxiety, SIMVASTATIN for Cholesterol, DILTIAZEM for Mitral valve prolapse, VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 01-Aug-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After first dose patient only experienced a sore arm for a couple of days.  Treatment information was not provided.   This case was linked to MOD-2022-536167, MOD-2022-536137 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vial was moved to fridge on the date of administration. The vial did not undergo temperature excursions. No adverse events reported by the patient after the administration error.  No treatment medication was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine moved to fridge on Date of administration. Published expiration Date on 25-Mar-2022. The vial did not undergone any temperature excursions. There were no adverse events reported by the patients after the administration error.  No Concomitant information was reported. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 1 dose administered 8 hours after the published expiry date/ Manufacturer date of expiry: April 7, 2022/ Date(s) of administration: April 8, 2022; Product moved to refrigeration:; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered 8 hours after the published expiry date/ Manufacturer date of expiry: April 7, 2022/ Date(s) of administration: April 8, 2022) and PRODUCT STORAGE ERROR (Product moved to refrigeration:) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered 8 hours after the published expiry date/ Manufacturer date of expiry: April 7, 2022/ Date(s) of administration: April 8, 2022) and PRODUCT STORAGE ERROR (Product moved to refrigeration:). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered 8 hours after the published expiry date/ Manufacturer date of expiry: April 7, 2022/ Date(s) of administration: April 8, 2022) and PRODUCT STORAGE ERROR (Product moved to refrigeration:) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Product moved to refrigeration on April 8, 2022 Treatment details was not reported by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  On date of administration, vial was moved to fridge and vial did not undergo any temperature excursion.   There were no adverse events reported by the patients after the administration error.  No  treatment information was reported by the reporter.   This case was linked to MOD-2022-536016 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the published expiration date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 and Dose 2 was Pfizer.). Past adverse reactions to the above products included No adverse event with Pfizer.    On 05-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. The vial did not undergone any temperature excursions. There were no adverse events reported by the patients after the administration error. No treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Vaccination site erythema, Vaccination site rash
Clinical narrative: Red rash at the injection site; Red rash at the injection site; Received full booster dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash at the injection site), VACCINATION SITE RASH (Red rash at the injection site) and ACCIDENTAL OVERDOSE (Received full booster dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21, 029L20A and 011L20A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu vaccine (3 weeks after the booster dose). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (Patient had many allergies to medicines and products but did not specify which ones.), Aortic valve stenosis (Patient had a cardiac aortic valve stenosis prior vaccination and After vaccination she went to her Doctor and noticed that her valve stenosis went from minor to moderate/severe condition. Her doctor said that it happens with age and did not attribute it to the vaccine.) and Thyroid disorder NOS.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and PRAVASTATIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter.   On 06-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received full booster dose). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red rash at the injection site) and VACCINATION SITE RASH (Red rash at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red rash at the injection site), VACCINATION SITE RASH (Red rash at the injection site) and ACCIDENTAL OVERDOSE (Received full booster dose) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not immunocompromised but received full dose of booster dose.   Patient did not tested positive for Covid-19.   No treatment medications were reported.   This case was linked to MOD-2022-536019 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 on 07Apr2022; AE regarding lack of efficacy; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for COVID-19 on 07Apr2022) and DRUG INEFFECTIVE (AE regarding lack of efficacy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 011J20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced COVID-19 (tested positive for COVID-19 on 07Apr2022) and DRUG INEFFECTIVE (AE regarding lack of efficacy). At the time of the report, COVID-19 (tested positive for COVID-19 on 07Apr2022) and DRUG INEFFECTIVE (AE regarding lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive for PCR test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Patient took booster dose on 05-Jan-2022. No treatment medication was reported.  Company comment:This spontaneous case concerns a patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID 19 , about 3 months and 2 days after receiving the booster dose and about 1 year, 2 months after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was reported. The interval between the 2 doses of primary series was approximately 28 days. The patient tested positive for COVID 19. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID 19 , about 3 months and 2 days after receiving the booster dose and about 1 year, 2 months after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was reported. The interval between the 2 doses of primary series was approximately 28 days. The patient tested positive for COVID 19. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: They inadvertently administered the 2nd booster dose to a couple who are less than 50 years old and who are not immunocompromised; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (They inadvertently administered the 2nd booster dose to a couple who are less than 50 years old and who are not immunocompromised) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065A21A, 093A21A, 045B21A and 071F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (They inadvertently administered the 2nd booster dose to a couple who are less than 50 years old and who are not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (They inadvertently administered the 2nd booster dose to a couple who are less than 50 years old and who are not immunocompromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was not immunocompromised. No concomitant drug was reported. The reporter stated that they started administering the second booster dose to patients in their facility. The patient received second booster dose on 8-Apr-2022. No treatment drug was reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Myalgia
Clinical narrative: muscle aches; 0.5mL 2nd booster instead of 0.25mL; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL) 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.   In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL). At the time of the report, MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL) outcome was unknown.            No Concomitant medications were provided.  Patient was at high risk but not immunocompromised.  It was reported that the patient had primary series Jan 2021 and 1st booster in August then recently received 0.5mL.  No treatment medications were provided.   This case was linked to MOD-2022-536492 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL). At the time of the report, MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL) outcome was unknown. Concomitant medications was not provided by the reporter. Patient got 0.5 mL as a 2nd booster dose instead of 0.25 mL. Stated that she and her husband both had a 0.5mL 2nd booster. Patient wife stated that she and her husband both had a primary series Jan2021 and booster in August. Treatment information was not provided. This case was linked to MOD-2022-536473 (Patient Link). Reporter did not allow further contact.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hyperhidrosis, Illness, Nasal congestion
Clinical narrative: Sore throat/ thought the sore throat was gone through the night but it wasn't; Has felt really sick; Sweats; Congestion; No energy/ up and down all night; Chills; This spontaneous case was reported by a physician assistant and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat/ thought the sore throat was gone through the night but it wasn't), ILLNESS (Has felt really sick), HYPERHIDROSIS (Sweats), NASAL CONGESTION (Congestion) and ASTHENIA (No energy/ up and down all night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 011A21A and 0251202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contrast media allergy (CT contrast), Allergy to arthropod sting (Wasps) and Depression. Concomitant products included BUPROPION HYDROBROMIDE (APLENZIN) for Depression, CALCIUM LEVOMEFOLATE (METHYL FOLATE [CALCIUM LEVOMEFOLATE]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, the patient experienced OROPHARYNGEAL PAIN (Sore throat/ thought the sore throat was gone through the night but it wasn't), ILLNESS (Has felt really sick), HYPERHIDROSIS (Sweats), NASAL CONGESTION (Congestion), ASTHENIA (No energy/ up and down all night) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat/ thought the sore throat was gone through the night but it wasn't) had not resolved and ILLNESS (Has felt really sick), HYPERHIDROSIS (Sweats), NASAL CONGESTION (Congestion), ASTHENIA (No energy/ up and down all night) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she was not feeling better at the time of report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat/ thought the sore throat was gone through the night but it wasn't; Has felt really sick; Sweats; Congestion; No energy/ up and down all night; Chills; This spontaneous case was reported by a physician assistant and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat/ thought the sore throat was gone through the night but it wasn't), ILLNESS (Has felt really sick), HYPERHIDROSIS (Sweats), NASAL CONGESTION (Congestion) and ASTHENIA (No energy/ up and down all night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 011A21A and 0251202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contrast media allergy (CT contrast), Allergy to arthropod sting (Wasps) and Depression. Concomitant products included BUPROPION HYDROBROMIDE (APLENZIN) for Depression, CALCIUM LEVOMEFOLATE (METHYL FOLATE [CALCIUM LEVOMEFOLATE]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, the patient experienced OROPHARYNGEAL PAIN (Sore throat/ thought the sore throat was gone through the night but it wasn't), ILLNESS (Has felt really sick), HYPERHIDROSIS (Sweats), NASAL CONGESTION (Congestion), ASTHENIA (No energy/ up and down all night) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat/ thought the sore throat was gone through the night but it wasn't) had not resolved and ILLNESS (Has felt really sick), HYPERHIDROSIS (Sweats), NASAL CONGESTION (Congestion), ASTHENIA (No energy/ up and down all night) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she was not feeling better at the time of report.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered
Clinical narrative: HCP will investigate if expired doses were administered; HCP says what if hypothetically doses were given.HCP will investigate if expired doses were administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP will investigate if expired doses were administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP says what if hypothetically doses were given.HCP will investigate if expired doses were administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP will investigate if expired doses were administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP says what if hypothetically doses were given.HCP will investigate if expired doses were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP will investigate if expired doses were administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP says what if hypothetically doses were given.HCP will investigate if expired doses were administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment  medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: patient only had the expected side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (patient only had the expected side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (patient only had the expected side effects). At the time of the report, VACCINATION COMPLICATION (patient only had the expected side effects) outcome was unknown.            Concomitant drugs were not reported.  Treatment details were not given.  Patient reported he only had the expected side effects, which were mild he didnot  have anything too severe.