chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 0377A22B) for COVID-19 vaccination.     The patient had no allergies and never had COVID positive test or diagnosis.  The patient had no other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Obesity and Neurogenic pain (Neuro pain).    On 27-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient didn't seek medical care and the reporter doesn't know if the patient had experienced a similar event in the past. Reportedly, the symptoms cleared up after 24 hours.  The height of the patient was unknown.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-615224, US-MODERNATX, INC.-MOD-2022-615226 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615224:(sister case) US-MODERNATX, INC.-MOD-2022-615226:(Child case-Daughter case)
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (scanned the vaccine box to pull up the expiration date it states 20-May-2022 but portal has the expiration date listed as 31-Dec-2069) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 prophylaxis. 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (scanned the vaccine box to pull up the expiration date it states 20-May-2022 but portal has the expiration date listed as 31-Dec-2069). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (scanned the vaccine box to pull up the expiration date it states 20-May-2022 but portal has the expiration date listed as 31-Dec-2069) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 0377A22B) for COVID-19 vaccination.     The patient had not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient had not COVID + test or diagnosis.  Concurrent medical conditions included Obesity, Nerve pain (Neuro pain), Allergy to antibiotic (Amoxicillin) and Penicillin allergy.    On 27-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient did not seek medical care for the event.   It was unknown if the patient experienced a similar event in the past.  The events lasted for 24 hours.  No treatment medications were reported.   This case was linked to MOD-2022-615220 (Patient Link).
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incorrect dose administered, Pain in extremity
Clinical narrative: Received adult dose; Fatigue; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue), PAIN IN EXTREMITY (Sore arm) and INCORRECT DOSE ADMINISTERED (Received adult dose) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0377A22B) for COVID-19 vaccination.     The patient ever had no COVID + test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose no).  Concurrent medical conditions included Allergy to antibiotic (Amoxycillin).    On 27-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In 2022, the patient experienced FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). On 27-Jun-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received adult dose). At the time of the report, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had resolved and INCORRECT DOSE ADMINISTERED (Received adult dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. Adverse event did not cause patient to seek medical care.  It was unknown that patient has experienced a similar event in the past. Adverse event lasted 24 hours. symptoms has improved or worsened.  No treatment information were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-615220 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615220:(Child case-Daughter case)
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Intervertebral disc protrusion, Nerve compression, Sciatica
Clinical narrative: back problem got worse after got the 1st booster dose; herniated disc; sciatica; pinched nerve; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back problem got worse after got the 1st booster dose), INTERVERTEBRAL DISC PROTRUSION (herniated disc), SCIATICA (sciatica) and NERVE COMPRESSION (pinched nerve) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 031L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder (little bit of a back trouble prior to getting the 1st booster dose of the vaccine).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced BACK PAIN (back problem got worse after got the 1st booster dose), INTERVERTEBRAL DISC PROTRUSION (herniated disc), SCIATICA (sciatica) and NERVE COMPRESSION (pinched nerve). The patient was treated with NAPROXEN SODIUM (ALEVE) for Back disorder, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Back disorder, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back problem got worse after got the 1st booster dose), INTERVERTEBRAL DISC PROTRUSION (herniated disc), SCIATICA (sciatica) and NERVE COMPRESSION (pinched nerve) outcome was unknown.            Patient asked if it was okay for them to get the second booster dose tonight on 27-Jul-2022 as they were taking Motrin and Aleve for little bit of a back trouble prior to first booster dose of the vaccine but it  was got worse in Dec2021 after they got the first booster dose. No concomitant information were reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-615244 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615244:Dose 2
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     It was unknown if the patient had any allergies to medications, food, and other products. It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if any other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Diabetes (Unknown if any recent change in status such as improvement or worsening). On 27-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter stated that the patient was administered with a volume of 0.25 ml of Moderna COVID-19 Vaccine booster dose only presentation (vial with blue cap) for a 2nd booster dose. The reporter was not aware of any Adverse events after the vaccine was administered for the patient and did not know if any treatment was given, or if the patient was under any concomitant or regular medication. The vaccination date for the first dose, second dose and first booster dose were unknown. The height of the patient was unknown. No treatment information was provided by the reporter. This case was linked to MODERNATX, INC.-MOD-2022-615296 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-615296:Other patient (Same Reporter).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058hala, 041c21a and 032b21a) for COVID-19 vaccination.     The patient had no history of acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Flu vaccination (He got sick after a flu vaccine.) in 2014. Past adverse reactions to the above products included Sickness with Flu vaccination. Concurrent medical conditions included Non-smoker (no smoking).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.            Concomitant medication include a couple of blood pressure pills. Patient stated that he do not drink, or take drugs and had been quarantined for ten days. No treatment medications was provided by the reporter.  Company comment: This is a spontaneous case concerning a 67-year-old, male patient with no relevant medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days. Patient experienced the unexpected non-serious event of Covid-19. The event occurred approximately 211 days after the third dose of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-604299 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 67-year-old, male patient with no relevant medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days. Patient experienced the unexpected non-serious event of Covid-19. The event occurred approximately 211 days after the third dose of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022; administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients) and PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients) and PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient has no known allergies. No concomitant medication were reported. The vial was initially stored in the refrigerator on 1Jun2022and was opened on the same day. The vial didn't undergo any temperature excursions. No treatment information were provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022; administered the vaccine from a vial that was open on 1Jun2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the vaccine from a vial that was open on 1Jun2022) and PRODUCT STORAGE ERROR (Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A and 076C21a) for COVID-19 prophylaxis.     It was unknown if patient ever had COVID positive test or diagnosis. Patient was not given any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Johnson & Johnson (Primary series: Dose 2) and Johnson & Johnson (Primary series: Dose 1). Past adverse reactions to the above products included No adverse event with Johnson & Johnson and Johnson & Johnson. Concurrent medical conditions included Penicillin allergy.   On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the vaccine from a vial that was open on 1Jun2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the vaccine from a vial that was open on 1Jun2022) and PRODUCT STORAGE ERROR (Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial was initially stored on 01-Jun-2022 in the refrigerator.  The patient did not seek any medical care. The patient did not experience a similar event in the past.  Treatment information was not provided by the reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022; Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022) and PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     It was unknown if the patient had medications, food and other products allergy. Medical history reported relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination was unknown. It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. It was unknown whether any other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Jhonson & Johson (First booster) on 28-Nov-2021, Jhonson & Johson (Primary series:2) and Jhonson & Johson (Primary series:1). Past adverse reactions to the above products included No adverse event with Jhonson & Johson, Jhonson & Johson and Jhonson & Johson.    On 27-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022) and PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received the second booster dose on 27-Jul-2022.  It was unknown whether adverse event cause patient to seek medical care. The patient did not experienced a similar event in the past. The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-May-2022 and administered on 15-Jul-2022; Patient was administered with dose after 30 days use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with dose after 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 15-Jul-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Patient had no acute illnesses at the time of vaccination and up to one month before and no chronic or long-standing health conditions.     On 15-Jul-2022 at 9:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Jul-2022 at 9:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with dose after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with dose after 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 15-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event were unknown.  It was reported that the vial had not undergone any temperature excursions. It was unknown that the patient had ever diagnosed with or tested positive for COVID-19.The patient had no adverse effects from the booster dose of Moderna vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-608558 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-608558:(patient M-H)
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Via was punctured on 18-Jul-2022 about 8AM to 8:15AM, stored in room temperature and administered on 19-Jul-2022 at 08:54 AM; Received expired 2nd booster beyond 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (Via was punctured on 18-Jul-2022 about 8AM to 8:15AM, stored in room temperature and administered on 19-Jul-2022 at 08:54 AM) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022 at 8:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022 at 8:54 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster beyond 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Via was punctured on 18-Jul-2022 about 8AM to 8:15AM, stored in room temperature and administered on 19-Jul-2022 at 08:54 AM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (Via was punctured on 18-Jul-2022 about 8AM to 8:15AM, stored in room temperature and administered on 19-Jul-2022 at 08:54 AM) 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.  Patient received second booster. Dose was administered more than 12 hours post puncture. Vial was arrived in liquid condition, and it was placed in the refrigerator. Vial did not undergo any temperature excursions. Vial was stored in room temperature post puncture. Total amount of time the vial was exposed to room temperature range (8-degree to 25- degree Celsius equals to 46-degree to 77-degree Fahrenheit) was 24 Hours.  No treatment medications were provided.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 12 People were vaccinated with the Moderna Covid 19 vaccine past its beyound use by date; 12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyound use by date) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyound use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyound use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Number of doses/vials reported were 3 vials and 12 doses. The dates of administration and number patients were reported as on16-Jul-2022 3 patients, on 23-Jul-2022 5 patients, on 24-Jul-2022 4 patients. All the vials were moved to fridge on the same day on 13-Jun-2022. The vial did not undergo any temperature excursions.   No treatment medication was provided.  This case contains information for the first of the 12 patients who received the vaccine on an unknown date in Jul-2022 as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-615215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Followup received and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615215:Master case
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date; Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  This case contains information of the 2nd out of 12th patients who received the vaccine on Jul-2022 as described by the reporter. Number of patients involved were 12 patients. Number of doses/vials reported  were 3 vials and 12 doses. The dates of administration and number patients were reported as on 16-Jul-2022 3 patients, on 23-Jul-2022 5 patients, on 24-Jul-2022 4 patients. All the vials were moved to fridge on the same day on 13-Jun-2022. The vial did not undergo any temperature excursions.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Live Follow Up received, reporter details and narrative updated.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. This case contains information of the three patient out of 12 patients who received the vaccine on Jul-2022 as described by the reporter. No concomitant medication was reported. Number of patients who received the vaccine beyond usage date were 12 patients. Number of doses/vials that were affected were 3 vials and 12 doses. The vial was initially stored in the refrigerator on 13-Jun-2022. The number of patients who received the vaccine on 16-Jul-2022 was 3, the number of patients who received the vaccine on 23-Jul-2022 was 5 and the number of patients who received the vaccine on 24-Jul-2022 was 4. The vial did not undergo any temperature excursion. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow Up received contains reporter details and narrative updated.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date; 12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The vial was initially stored in the refrigerator on 13Jun2022. A total of 12 doses were given to 12 patients from 3 vials. The vial didn't undergo any temperature excursions. Dates of administration of vaccine were 16Jul2022- 3patients, 23Jul2022-5patients and 24Jul2022-4patients. No treatment information were provided. This case contains the information of the fourth of 12 patient.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Live Follow Up - Significant Information contains reporter's email updated and  narrative updated.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its best use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. Number of patients involved were 12 patients. Number of doses, vials reported  were 3 vials and 12 doses.The dates of administration and number patients were reported as on16-Jul-2022 to 3 patients, on 23-Jul-2022 to 5 patients, on 24-Jul-2022 to 4 patients. All the vials were moved to fridge on the same day on 13-Jun-2022. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 5th of the 12 patients who received the vaccine on Jul-2022 as described by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow up received contains updated reporter contact detail and narrative updated.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days; Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case contains information of the sixth patient out of 12 patients who received the vaccine on Jul-2022 as described by the reporter.  No concomitant medication information was provided.  Number of patients who received the vaccine beyond usage date were 12 patients.  Number of doses/vials that were affected were 3 vials and 12 doses.  The vial was initially stored in the refrigerator on 13-Jun-2022 and all the vials were moved to the fridge on the same day.  The number of patients who received the vaccine on 16-Jul-2022 was 3, the number of patients who received the vaccine on 23-Jul-2022 was 5 and the number of patients who received the vaccine on 24-Jul-2022 was 4.  The vial did not undergo any temperature excursion.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow-up received includes updated reporter's email address.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Initially stored in the refrigerator on 13Jun2022 and administration of vaccine on 16Jul2022, 23Jul2022, 24Jul2022; 12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 13Jun2022 and administration of vaccine on 16Jul2022, 23Jul2022, 24Jul2022) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 13Jun2022 and administration of vaccine on 16Jul2022, 23Jul2022, 24Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 13Jun2022 and administration of vaccine on 16Jul2022, 23Jul2022, 24Jul2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The number of doses/vials reported were 3 vials and 12 doses. The vial was initially stored in the refrigerator on 13-Jun-2022. The dates of administration and number patients were reported as on 16-Jul-2022 3 patients, on 23-Jul-2022 5 patients and on 24-Jul-2022 4 patients. All the vials were moved to fridge on the same day on 13-Jun-2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.  This case contains the information of the eighth of 12 patient who received the vaccine on Jul-2022 as described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-615215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow Up received contains reporter details and updated narrative.; Sender's Comments:  MODERNATX, INC.-MOD-2022-615215:Master Case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022; Vaccine administered 30 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A and 02602HA) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. It was reported, acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.    On 28-Oct-2021 at 12:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Jul-2022 at 11:38 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Jul-2022 at 11:38 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15 Jun 2022 and administered on 18 Jul 2022).    Concomitant medications details were not reported by the reporter.  Patient reported no adverse events. The events did not cause the patient to seek medical care.  Treatment details were not reported by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-610650 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-610650:Master case
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Overdose, Product preparation issue
Clinical narrative: 0.2ml dose given without dilution - no immediate effects; 0.2ml dose given without dilution - no immediate effects; fatigue; nausea; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 6-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2022 as dose 3 (booster), single (Lot number: PAA177913) at the age of 6 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "ADHD (attention deficit hyperactivity disorder)" (unspecified if ongoing), notes: ADHD (attention deficit hyperactivity disorder). Concomitant medication(s) included: CETIRIZINE; MELATONIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FK5127; Location of injection: Arm Right; , Administration Time: 10:15 AM; Route of Administration: Intramuscular), administration date: 07Dec2021, when the patient was 6-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: FK5127; Location of injection: Arm Right; Administration Time: 10:45 AM; Route of Administration: Intramuscular), administration date: 03Nov2021, when the patient was 6-year-old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "recovered" (2022); NAUSEA (non-serious) with onset 2022, outcome "recovered" (2022); OVERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 30Jun2022 at 11:30, outcome "recovering" and all described as "0.2ml dose given without dilution - no immediate effects". Therapeutic measures were taken as a result of fatigue, nausea. Therapeutic measures were not taken as a result of overdose, product preparation issue.  Additional information: Patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and not tested for COVID post vaccination. Patient had no known allergies. Device timestamp: 01Jul2022. The patient did not have relevant test and not specific relevant test for thromboembolic events with thrombocytopenia. The reporter assessed the events as non-serious. The patient received Zofran as a treatment medication for nausea and ibuprofen as a treatment medication for fatigue. Mixing diluent did not happen prior to dose given.   Follow-Up (07Jul2022): Follow-up attempts are completed. No further information is expected.  Follow-up (27Jul2022): This is a spontaneous follow up report from a contactable nurse. This nurse reported for the patient in response to HCP letter (sent to physician) via follow-up letter. Updated information included: At risk classification removed. Reporter details added, suspect details added, new events of nausea and fatigue added and additional information updated.