chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).; Patient received  Moderna vaccine  Booster on 04/08/2022. Vaccine was given beyond use date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received  Moderna vaccine  Booster on 04/08/2022. Vaccine was given beyond use date.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 025C21A and 025C21A) for COVID-19 vaccination.     It was reported that the patient did not have any acute illness at the time of vaccination and up to one month before. It was unknown that patient had any chronic illness or long-standing health conditions. It was unknown that patient neither diagnosed with COVID-19 nor tested positive.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Apr-2022, received third 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 EXPIRED PRODUCT ADMINISTERED (Patient received  Moderna vaccine  Booster on 04/08/2022. Vaccine was given beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received  Moderna vaccine  Booster on 04/08/2022. Vaccine was given beyond use date.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient received  Moderna vaccine  Booster on 04/08/2022. Vaccine was given beyond use date.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).) to be not related.    Concomitant products were not provided.  It was reported that the patient received Moderna vaccine which was given beyond use date. Vaccine was received in refrigerator on 07-Mar-2022 in appropriate temperature (2-8 Celsius). Vaccine was administered to patient 2 days past the 30 day time in refrigerator. It was reported that patient did not seek medical care and patient did not experienced any similar event in the past. There were no any other potential causes for the event to occur.  Treatment medications were not reported.
Age: 67.0
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; 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 (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 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia, Hypothyroidism and Diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE), DOCUSATE SODIUM (COLACE), METFORMIN, VALPROATE SEMISODIUM (DIVALPROEX), LISINOPRIL, GLIMEPIRIDE, ATORVASTATIN CALCIUM, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE SODIUM for an unknown indication.    On 13-Apr-2022 at 3:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 3:17 PM,  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 (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 (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.   No known allergy was reported to medications, food, and other products. Other additional concomitant medication included True Metrix for an unknown indication. The vial was initially stored in refrigerator on 25-Feb-2022. The vial did not undergo any temperature excursion. The patient was vaccinated past the 30 day storage period. Patient did not experienced covid infection within last month from this report. The patient did not experience any side effects. No treatment details were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy, Product storage error
Clinical narrative: received a vaccine past the 30 day storage on the refrigerator; Maternal exposure during pregnancy; doses administered after 30-day Use By Date; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date), PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergies.  Concurrent medical conditions included Pregnant. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Apr-2022 at 9:29 AM, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator). On 06-Apr-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. The vial was initially stored in the refrigerator on 25-Feb-2022. The vial was not undergone any temperature excursion.  Company comment: This is an spontaneous case of maternal exposure during pregnancy for a 30-year-old female patient, with no medical history reported, who experienced the non-serious unexpected events of Expired product administered and product storage error, after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is an spontaneous case of maternal exposure during pregnancy for a 30-year-old female patient, with no medical history reported, who experienced the non-serious unexpected events of Expired product administered and product storage error, after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
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; 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 (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 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (LANTUS allergy), Drug allergy (PENICILLIN V POTASSIUM allergy) and Type 2 diabetes mellitus. Concomitant products included TERCONAZOLE, BETAMETHASONE, CLOTRIMAZOLE (CLOTRIMAZOLE AND BETAMETHASONE), SALBUTAMOL (VENTOLIN [SALBUTAMOL]), LORATADINE, ALBUTEROL SULFATE, MELOXICAM, LANSOPRAZOL, ASPIRIN [ACETYLSALICYLIC ACID], SIMVASTATIN and LISINOPRIL for an unknown indication.    On 13-Apr-2022 at 4:01 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022 at 4:01 PM,  after starting mRNA-1273 (Spikevax), 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 (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 (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 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications included BD Pen and NovoFine.  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: 64.0
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 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hyperlipidemia, Hypertension and Allergy. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE for Allergy.    On 06-Apr-2022 at 4:04 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 4:04 PM, 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. 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: After the first dose, after about a week, he got a little circle around where the shot was; it was pink.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (After the first dose, after about a week, he got a little circle around where the shot was; it was pink.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Atrial fibrillation.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (After the first dose, after about a week, he got a little circle around where the shot was; it was pink.). At the time of the report, VACCINATION SITE ERYTHEMA (After the first dose, after about a week, he got a little circle around where the shot was; it was pink.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medications were reported by the reporter. The patient had a severe reaction on the last one. The doctor told him it might be best not to take the booster. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   This case was linked to MOD-2022-546749 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 25-Feb-2022/Patient received the vaccine which was past the 30-day storage on the refrigerator/ Doses were applied between the 01-Apr-2022 and 08-Apr-2022; Dose administered after 30-day Use By Date or after manufacturer date/Patient was 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 or after manufacturer date/Patient was vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Feb-2022/Patient received the vaccine which was past the 30-day storage on the refrigerator/ Doses were applied between the 01-Apr-2022 and 08-Apr-2022) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient has No known dug allergies (NKDA).  Concurrent medical conditions included Hypertension (HTN) and Type 2 diabetes mellitus (DMII). Concomitant products included LOSARTAN and METFORMIN for an unknown indication.    On 20-Apr-2022 at 10:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 10:07 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date/Patient was vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Feb-2022/Patient received the vaccine which was past the 30-day storage on the refrigerator/ Doses were applied between the 01-Apr-2022 and 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date/Patient was vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Feb-2022/Patient received the vaccine which was past the 30-day storage on the refrigerator/ Doses were applied between the 01-Apr-2022 and 08-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 the vial was initially stored on refrigerator on 25-Feb-2022. Number of doses/vial used were 36. The vial did not undergo temperature excursion.
Age: 57.0
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 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known allergies.  Concomitant products included AMLODIPINE, LOSARTAN, PHENYTOIN SODIUM, GABAPENTIN, INSULIN GLARGINE (BASAGLAR), NAPROXEN, ASA and ATORVASTATIN for an unknown indication.    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 (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 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.  Treatment medications were not reported.
Age: 42.0
Sex: M
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 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergies, none daily medications were reported. Patient did not have positive or negative COVID-19 within last month of vaccination. None acute or chronic illness was reported.     On 01-Apr-2022 at 9:21 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 9:21 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.   Treatment details were not given.  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 01-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: 91.0
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; 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 25Feb2022 and date administered on 06 Apr 2022) in a 90-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.  The patient's past medical history included Stent placement. Concurrent medical conditions included Hypertension, Diabetes mellitus and Peripheral vascular disease. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL, ACETAMINOPHEN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) and MEMANTINE for an unknown indication.    On 06-Apr-2022 at 9:13 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021 at 9:13 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 25Feb2022 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 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.   The expiration date was reported as 25 Mar 2022. It was reported that patients that received a vaccine past the 30 day storage on the refrigerator. It was reported that the vial did not undergo any temperature excursions. No treatment medications were provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses administered after 30-day Use By Date and expiry date; doses administered after 30-day Use By Date and 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 expiry date) and PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known drug allergies. The patient had no chronic/acute illness and it was unknown if the patient tested positive/negative for COVID-19 within last month.  Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.    In April 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date) and PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The number of doses/vials was 36.  The vial was initially stored in the refrigerator on 25-Feb-2022.  It was reported that date and time of administration of vaccine was 1-Apr-2022 and 8-Apr-2022.  The vials did not undergo any temperature excursion.  The patient had not received any daily medications.  HCP confirmed that the patient was not experiencing any side effects at the time of reporting.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Spikevax 133% Full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Spikevax 133% Full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: comirnaty, comirnaty and comirnaty. Past adverse reactions to the above products included No adverse event with comirnaty, comirnaty and comirnaty. Concurrent medical conditions included Primary immunodeficiency syndrome.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Spikevax 133% Full dose). At the time of the report, ACCIDENTAL OVERDOSE (Spikevax 133% Full dose) outcome was unknown.            No concomitant medication was reported. It was reported that patient took 3 Comirnaty (BioNtech), 2 Spikevax (Moderna 100 percent and 133 percent full dose). Patient also reported that every booster resulted in broader AB answer (yet with very low titers due to PID). No treatment medication was reported.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Eye pain, Migraine, Pain in jaw, Toothache
Clinical narrative: Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine; Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine; Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine; Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine; Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine), TOOTHACHE (Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine), EYE PAIN (Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine), EAR PAIN (Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine) and MIGRAINE (Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination.     Concomitant products included ZINC for Allergic rhinitis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN JAW (Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine), TOOTHACHE (Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine), EYE PAIN (Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine) and EAR PAIN (Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine). On an unknown date, the patient experienced MIGRAINE (Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN JAW (Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine), TOOTHACHE (Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine), EYE PAIN (Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine), EAR PAIN (Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine) and MIGRAINE (Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's concomitant medications included 2 different types of eye drops for Glaucoma, nasal spray for allergic rhinitis.  The patient suspected the events had something to do with sinuses.  Patient suspected that she might had COVID-19 since she experienced some symptoms.   This case was linked to MOD-2022-546759 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine; Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine; Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine; Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine; Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine), TOOTHACHE (Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine), EYE PAIN (Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine), EAR PAIN (Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine) and MIGRAINE (Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination.     Concomitant products included ZINC for Allergic rhinitis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN JAW (Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine), TOOTHACHE (Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine), EYE PAIN (Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine) and EAR PAIN (Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine). On an unknown date, the patient experienced MIGRAINE (Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN JAW (Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine), TOOTHACHE (Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine), EYE PAIN (Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine), EAR PAIN (Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine) and MIGRAINE (Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's concomitant medications included 2 different types of eye drops for Glaucoma, nasal spray for allergic rhinitis.  The patient suspected the events had something to do with sinuses.  Patient suspected that she might had COVID-19 since she experienced some symptoms.   This case was linked to MOD-2022-546759 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19, Toothache
Clinical narrative: Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine; Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine; Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine; Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine; Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine), TOOTHACHE (Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine), EYE PAIN (Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine), EAR PAIN (Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine) and MIGRAINE (Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination.     Concomitant products included ZINC for Allergic rhinitis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN JAW (Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine), TOOTHACHE (Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine), EYE PAIN (Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine) and EAR PAIN (Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine). On an unknown date, the patient experienced MIGRAINE (Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN JAW (Cheekbone hurt after receiving the second dose of the Moderna Covid 19 vaccine), TOOTHACHE (Teeth hurt after receiving the second dose of the Moderna Covid 19 vaccine), EYE PAIN (Eyes hurt after receiving the second dose of the Moderna Covid 19 vaccine), EAR PAIN (Ear Pain after receiving the second dose of the Moderna Covid 19 vaccine) and MIGRAINE (Pain that remains of migraine after receiving the second dose of the Moderna Covid 19 vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's concomitant medications included 2 different types of eye drops for Glaucoma, nasal spray for allergic rhinitis.  The patient suspected the events had something to do with sinuses.  Patient suspected that she might had COVID-19 since she experienced some symptoms.   This case was linked to MOD-2022-546759 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 25-Feb-2022 and 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 (Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known allergies.  Patient did not have COVID-19 preceding the month of vaccination.  Concurrent medical conditions included Diabetes, Anemia, Hyperlipidemia and Thrombocytopenia. Concomitant products included GLIPIZIDE for an unknown indication.    On 06-Apr-2022 at 3:14 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:14 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 (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 (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (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.   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.  Treatment details were not given.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Dispensed 28 doses of expired Moderna Covid-19 vaccine, patient received expired vaccine on 08-Apr-2022; Accidental overdose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine, patient received expired vaccine on 08-Apr-2022) and ACCIDENTAL OVERDOSE (Accidental overdose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient had no medical history of COVID-19.     On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine, patient received expired vaccine on 08-Apr-2022) and ACCIDENTAL OVERDOSE (Accidental overdose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine, patient received expired vaccine on 08-Apr-2022) and ACCIDENTAL OVERDOSE (Accidental overdose) 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. Vial did not undergo any temperature excursions. No adverse event was reported. The vaccine given had a expiry date 18-Mar-2022 but the Moderna stability study showed the vaccine was active against COVID-19 for that date. No treatment medication was provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20Apr2022; Expired vaccine used; 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 20Apr2022) in a 57-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 and food.  Concurrent medical conditions included Sarcoidosis, Type 2 diabetes mellitus and Multiple myeloma. Concomitant products included SIMVASTATIN, ZOLEDRONIC ACID MONOHYDRATE (ZOMETA), METFORMIN, DEXAMETHASONE, LISINOPRIL, LEVOTHYROXINE and GABAPENTIN for an unknown indication.    On 20-Apr-2022 at 9:26 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 9:26 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 20Apr2022). 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 20Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received other medication such as Acyclovir Dose administered after 30 day use by date or after manufacturer date of expiry. Number of doses or vials administered 36 doses. Date and time the vial was initially stored in the refrigerator 25-Feb-2022. Date and time of administration of vaccine was 01-Apr-2022 and 08-Apr-2022. The vial had not undergone any temperature excursion.  No treatment medications were reported
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses administered after 30-day Use By Date and expiry date; doses administered after 30-day Use By Date and 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 expiry date) and PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     It was reported that Patient did not have COVID positive or negative  within last month.  The patient's past medical history included Anemia. Concurrent medical conditions included Diabetes, Drug allergy (Allergy to Glipizide) and Drug allergy (Allergy to Novolin 70/30). Concomitant products included METFORMIN and LISINOPRIL for an unknown indication.    On 06-Apr-2022 at 3:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date) and PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Concomitant medication included Lantus Solostar The number of doses/vials was 36. The vial was initially stored in the refrigerator on 25-Feb-2022 The vials did not undergo any temperature excursion. The healthcare professional (HCP) wanted to know how to proceed with 36 patients that received a vaccine past the 30 day storage on the refrigerator. HCP confirmed that the patients were not experiencing any side effects yet. No treatments were reported
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We dispensed 28 doses of expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We dispensed 28 doses of expired Moderna COVID-19 vaccine) in a male 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 (We dispensed 28 doses of expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We dispensed 28 doses of expired 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 medication was reported. It was reported that patient had no known allergies at the time of vaccination. Patient reported no adverse events after vaccination. The vial did not undergo any temperature excursions. On unknown date the vial was initially stored in the refrigerator. Patient had never been diagnosed with or tested positive for COVID-19. The result of stability study shows full activity against COVID-19. No treatment medication was reported.
Age: 62.0
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/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 01-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 (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 01-Apr-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Diabetes mellitus, Hypertension, Sciatica and Fibromyalgia.    On 01-Apr-2022 at 11:24 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 11:24 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 01-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 (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 01-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 the patient was on multiple medications. The patient took booster dose. The vial was initially stored in the refrigerator on 25-Feb-2022, its 30 day used by date was 25-Mar-2022. The vial did not underwent any temperature excursions.  It was reported that the patient did not experienced any side effect. No treatment information was reported. The patient not had COVID-19 within last month.