chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Scar
Clinical narrative: HAD SOME SCARS THAT LOOKS LIKE BRUISES FROM THE FIRST STAGE OF PSORIASIS; HAD DOTS ON UPPER BODY/ STILL HAS SOME SCARRING; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (HAD SOME SCARS THAT LOOKS LIKE BRUISES FROM THE FIRST STAGE OF PSORIASIS) and SCAR (HAD DOTS ON UPPER BODY/ STILL HAS SOME SCARRING) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONTUSION (HAD SOME SCARS THAT LOOKS LIKE BRUISES FROM THE FIRST STAGE OF PSORIASIS) and SCAR (HAD DOTS ON UPPER BODY/ STILL HAS SOME SCARRING). At the time of the report, CONTUSION (HAD SOME SCARS THAT LOOKS LIKE BRUISES FROM THE FIRST STAGE OF PSORIASIS) was resolving and SCAR (HAD DOTS ON UPPER BODY/ STILL HAS SOME SCARRING) had not resolved.            No concomitant drug information was provided.  It was unknown if the patient was enrolled in clinical trial.  The reporter's causality for the reported events with respect to Humira was not provided.  No treatment drug information was provided..
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine expired in the freezer on 6Apr2022 and the vial was initially stored in the refrigerator: 28Apr2022, and 4Apr2022; administer expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022 and the vial was initially stored in the refrigerator: 28Apr2022, and 4Apr2022) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022 and the vial was initially stored in the refrigerator: 28Apr2022, and 4Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022 and the vial was initially stored in the refrigerator: 28Apr2022, and 4Apr2022) 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 (medications, food and other products). Patient neither tested nor diagnosed with COVID positive ever. It was unknown whether patient received other vaccines within 1 month prior to Modena COVID-19 vaccine. No concomitant medications were reported.  Dose administered after 30-day Use By Date or after manufacturer date of expiry. On 28-Apr-2022 and 04-Apr-2022, the vials were stored in the refrigerator. The vials did not underwent any temperature excursions. It was unknown whether the AE caused patient to seek medical care. It was unknown whether patient experienced similar event in the past.   This case was linked to MOD-2022-593844, MOD-2022-593855, MOD-2022-593856, MOD-2022-593859 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022 and was administered on 14-Jun-2022; Moderna COVID-19 vaccine was administered after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022 and was administered on 14-Jun-2022) in an 89-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022 and was administered on 14-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022 and was administered on 14-Jun-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vaccine manufacture date was 13-Dec-2021.  This patient had not experienced any symptoms after receiving this dose of the vaccine. No additional doses, medications, or treatments had been administered in response to this error.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered
Clinical narrative: administered vaccine prior to confirming expiration date; administered vaccine prior to confirming expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine prior to confirming expiration date) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (administered vaccine prior to confirming expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) 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 EXPIRED PRODUCT ADMINISTERED (administered vaccine prior to confirming expiration date) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (administered vaccine prior to confirming expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccine prior to confirming expiration date) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (administered vaccine prior to confirming expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   HCP stated they eventually found the expiration date after they had given a vaccine. No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Lymphadenopathy, Neck pain, Swelling
Clinical narrative: sore and  swollen neck area; sore and  swollen neck area; feel the lymph nodes swollen in their neck and they are warm to the touch; is red where she got the injection warm  to the touch; feel the lymph nodes swollen in their neck and they are warm to the touch; is red where she got the injection warm  to the touch; left shoulder is sore; their arm was sore; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (sore and  swollen neck area), SWELLING (sore and  swollen neck area), FEELING HOT (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE WARMTH (is red where she got the injection warm  to the touch) and LYMPHADENOPATHY (feel the lymph nodes swollen in their neck and they are warm to the touch) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug hypersensitivity. Concomitant products included METOPROLOL, ALPRAZOLAM (XANAX) and PEPSIN for an unknown indication.    On 22-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2022, the patient experienced VACCINATION SITE PAIN (their arm was sore). On 23-Jun-2022, the patient experienced NECK PAIN (sore and  swollen neck area), SWELLING (sore and  swollen neck area), FEELING HOT (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE WARMTH (is red where she got the injection warm  to the touch), LYMPHADENOPATHY (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE ERYTHEMA (is red where she got the injection warm  to the touch) and ARTHRALGIA (left shoulder is sore). At the time of the report, NECK PAIN (sore and  swollen neck area), SWELLING (sore and  swollen neck area), FEELING HOT (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE WARMTH (is red where she got the injection warm  to the touch), LYMPHADENOPATHY (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE PAIN (their arm was sore), VACCINATION SITE ERYTHEMA (is red where she got the injection warm  to the touch) and ARTHRALGIA (left shoulder is sore) had not resolved.            The patient never tested COVID-19 Positive, neither experienced similar event in the past. No other vaccine were given within 1 month prior to Moderna COVID-19 vaccine. The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: sore and  swollen neck area; sore and  swollen neck area; feel the lymph nodes swollen in their neck and they are warm to the touch; is red where she got the injection warm  to the touch; feel the lymph nodes swollen in their neck and they are warm to the touch; is red where she got the injection warm  to the touch; left shoulder is sore; their arm was sore; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (sore and  swollen neck area), SWELLING (sore and  swollen neck area), FEELING HOT (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE WARMTH (is red where she got the injection warm  to the touch) and LYMPHADENOPATHY (feel the lymph nodes swollen in their neck and they are warm to the touch) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug hypersensitivity. Concomitant products included METOPROLOL, ALPRAZOLAM (XANAX) and PEPSIN for an unknown indication.    On 22-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2022, the patient experienced VACCINATION SITE PAIN (their arm was sore). On 23-Jun-2022, the patient experienced NECK PAIN (sore and  swollen neck area), SWELLING (sore and  swollen neck area), FEELING HOT (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE WARMTH (is red where she got the injection warm  to the touch), LYMPHADENOPATHY (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE ERYTHEMA (is red where she got the injection warm  to the touch) and ARTHRALGIA (left shoulder is sore). At the time of the report, NECK PAIN (sore and  swollen neck area), SWELLING (sore and  swollen neck area), FEELING HOT (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE WARMTH (is red where she got the injection warm  to the touch), LYMPHADENOPATHY (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE PAIN (their arm was sore), VACCINATION SITE ERYTHEMA (is red where she got the injection warm  to the touch) and ARTHRALGIA (left shoulder is sore) had not resolved.            The patient never tested COVID-19 Positive, neither experienced similar event in the past. No other vaccine were given within 1 month prior to Moderna COVID-19 vaccine. The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). No treatment medications were reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension
Clinical narrative: patient started to experience lowpressure again; This spontaneous case was reported by a patient and describes the occurrence of HYPOTENSION (patient started to experience lowpressure again) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042j21a, 032m20a and 011m20a) for COVID-19 prophylaxis.     The patient's past medical history included Hypertension and Dialysis (Patient has been in dialysis for 7 years) since an unknown date. Concurrent medical conditions included Latex allergy, Allergy to antibiotic (contrast cepicillin) and Drug allergy (same family antibiotics ecogen drug to produce red blood cells).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (patient started to experience lowpressure again). At the time of the report, HYPOTENSION (patient started to experience lowpressure again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 100/60 100/60.         Concomitant medications were not reported.  Patient was allergic to teghade.  The patient had reported after vaccination with second dose, patient had low blood pressure - 100/60 and was not able to rise it and lasted for 6 months when it resolved. Patient stopped regular medication for high blood pressure, patient used to have with 2 medications ad blood pressure used to be 140/90. After vaccination with the 1st booster dose patient started to experience lowpressure again.  Patient had scheduled a transplant after receiving the vaccine for a condition that was diagnosed before receiving the vaccine .Patient had been in dialysis for 7 years and 2 days ago with general anesthesia the low pressure went so lowthat the transplant had to be canceled and their HCPs were not able to rise the patient's blood pressure. Patient never had low blood pressure before   Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: 4 hours after vaccination I had my menstrual cycle 2 weeks early; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (4 hours after vaccination I had my menstrual cycle 2 weeks early) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MENSTRUATION IRREGULAR (4 hours after vaccination I had my menstrual cycle 2 weeks early). At the time of the report, MENSTRUATION IRREGULAR (4 hours after vaccination I had my menstrual cycle 2 weeks early) had not resolved.            Concomitant product was not provided.  The patient was vaccinated last year in january and february (unspecified dates). 4 hours after vaccination the patient had menstrual cycle 2 weeks early, this happened again after her second dose. The patient had her period every 2 weeks for over a year, as well as new cyst on her ovaries and a hemorrhagic cyst as well. She would like more information on people who also had this side effect.   Treatment medication was not reported.   This case was linked to MOD-2022-594076 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was initially moved from  the freezer to the refrigerator on 10-May-2022 and was administered on 13-Jun-2022; Moderna COVID-19 vaccine was administered after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from  the freezer to the refrigerator on 10-May-2022 and was administered on 13-Jun-2022) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially moved from  the freezer to the refrigerator on 10-May-2022 and was administered on 13-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from  the freezer to the refrigerator on 10-May-2022 and was administered on 13-Jun-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022, and the manufactured date was 13-Dec-2021.  It was reported that the vial had not undergone any temperature excursions.  It was also reported that the patient had not experienced any symptoms after receiving this dose of the vaccine. Reportedly, no additional doses, medications, or treatments had been administered in response to this error.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: may have given the child Pfizer instead of Moderna; may have given the child Pfizer instead of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (may have given the child Pfizer instead of Moderna) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (may have given the child Pfizer instead of Moderna) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (may have given the child Pfizer instead of Moderna) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (may have given the child Pfizer instead of Moderna). At the time of the report, WRONG PRODUCT ADMINISTERED (may have given the child Pfizer instead of Moderna) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (may have given the child Pfizer instead of Moderna) outcome was unknown.            No concomitant medication was reported. Reporter states that she already got the vaccine and everything online was a different color than the one she saw. Reporter thinks she saw the label was orange, reporter did not remember the cap color. Reporter saw online that the orange cap was Pfizer she thinks and they might had given the child Pfizer instead of Moderna. Reporter says she was 99 percent sure the vial was orange. Reporter was  wondering and wanted to double check. No treatment medication was reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond use date; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 37 years and 7 months.  Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.  No treatment information was provided by the reporter.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 24 years and 5 months. No concomitant drug information was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine number 1 NDC code was reported as 80777027399. No treatment drug information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if the patient ever had COVID + test or diagnosis. It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's age was reported as 48 years and 5 months  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event.  The patient did not experienced any adverse reactions after the administration of vaccine.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process after an audit was conducted  The vaccine NDC code was reported as 80777-0273-99  No treatment information was provided by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond use date; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  Patient age was reported as 64 years and 2 months. Code was mentioned as 80777-0273-99. It was reported that on 10-Jun-2022 notified of an audit that was done and were then made aware of vaccines that were administrated beyond use date after the thaw process. There was no patients that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medication was provided by the reporter.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported no adverse reactions after the administration of vaccine.  No treatment medications were reported.  Vaccine number 1 NDC code was reported as 80777-0273-99.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Expired product administered
Clinical narrative: Vaccine administered beyond use date; Second dose received 0.25 instead of 0.5 ml; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) and ACCIDENTAL UNDERDOSE (Second dose received 0.25 instead of 0.5 ml) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.     On 28-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) and ACCIDENTAL UNDERDOSE (Second dose received 0.25 instead of 0.5 ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) and ACCIDENTAL UNDERDOSE (Second dose received 0.25 instead of 0.5 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 25 years and 5 months.  Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  No treatment information was provided by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  Patient age was reported as 27 year 8 Month.   It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations.  Vaccine number 1 NDC code was reported as 80777027399.  No treatment drug information was provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had chronic or long lasting health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient's age was 34 years 10 months.  It was reported that the patient had no adverse reactions after the administration of the vaccine. It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19. The vaccine was administered beyond use date after the thaw process. No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  Patient age was reported as 20  years and 10 months.  Ndc Code was mentioned. It was reported that on 10-Jun-2022 was notified of an audit that was done and were then made aware of vaccines that were administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medication was provided by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 83 years and 2 months. No concomitant medication was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code- 80777-0273-99. No treatment medication was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before. Unknown if patient had Chronic or long standing health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 32 years and 9 months.   It was unknown that prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event.  It was reported that vaccine was administered beyond use date to patient. There was no adverse reaction noted or reported regarding these administrations.  No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations. On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777027399. No treatment medication was reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/Expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/Expired vaccine administered) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 22 years and 8 months. Concomitant medication of the patient was not reported.The patient did not experience any adverse reactions after the administration of vaccine.On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99. No treatment information was provided by the reporter
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient ever had tested or diagnosed positive for COVID. It was unknown if patient had Acute or Chronic/ long-standing illnesses at the time of vaccination or up to 1 month prior to vaccination. Information about other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown.     On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 23 years and 10 months.   No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication was provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.  No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient age was reported as 27 years and 8 months. Concomitant medication of the patient was not reported. The patient did not experience any adverse reactions after the administration of vaccine. On 10 Jun 2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine code 80777027399.  No treatment information was provided by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient was ever diagnosed with/ tested positive for COVID-19. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before or chronic/ long-lasting health conditions.     On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Vaccine number 1 NDC code was reported as 80777-0273-99. The patient did not had any adverse reactions after the administration of the vaccines. Pfizer-BioNTech COVID-19 Vaccine (+12) requested.  No treatment medication was reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before. unknown if patient had Chronic or long-standing health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  It was unknown if patient received prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event. Treatment medications were not reported.