chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive for COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 026L20A) for COVID-19 vaccination. Co-suspect product included non-company product LEVOTHYROXINE for Hypothyroidism.Concurrent medical conditions included Hypothyroidism.On 05-Jan-2021 at 8:09 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter.On 02-Feb-2021 at 7:51 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter.On an unknown date, the patient started LEVOTHYROXINE (Oral) 88 microgram once a day. Last menstrual period and estimated date of delivery were not provided. On 28-Oct-2021, the patient experienced COVID-19 (Patient tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 28-Oct-2021, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, COVID-19 (Patient tested positive for COVID-19) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 28-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No treatment medication was reported. Company Comment: This is a Spontaneous case concerning a 26-year-old female patient, pregnant, who experienced the non-serious unexpected AESI of COVID-19. Also, the special situations of Maternal exposure during pregnancy and Drug ineffective was reported. The event occurred 8 months and 27 days after the administration of the second dose of the mRNA-1273 vaccine of a proper schedule of product administration (29 days between first and second dose). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious. This case was linked to MOD-2022-473095 (Patient Link). Sender's Comments: This is a Spontaneous case concerning a 26-year-old female patient, pregnant, who experienced the non-serious unexpected AESI of COVID-19. Also, the special situations of Maternal exposure during pregnancy and Drug ineffective was reported. The event occurred 8 months and 27 days after the administration of the second dose of the mRNA-1273 vaccine of a proper schedule of product administration (29 days between first and second dose). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Head discomfort, Pyrexia, Vaccination complication, Vaccination site reaction
Clinical narrative: problems with the head; about concerning the side effect; Problem with the same arm; temperature over of a 100°F, temperature and had 100.1°F; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (problems with the head), VACCINATION COMPLICATION (about concerning the side effect), VACCINATION SITE REACTION (Problem with the same arm) and PYREXIA (temperature over of a 100°F, temperature and had 100.1°F) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (problems with the head), VACCINATION COMPLICATION (about concerning the side effect), VACCINATION SITE REACTION (Problem with the same arm) and PYREXIA (temperature over of a 100°F, temperature and had 100.1°F). At the time of the report, HEAD DISCOMFORT (problems with the head), VACCINATION COMPLICATION (about concerning the side effect), VACCINATION SITE REACTION (Problem with the same arm) and PYREXIA (temperature over of a 100°F, temperature and had 100.1°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Body temperature: 100 (High) 100°F and 100.1 (High) 100.1°F.         No concomitant medications were reported. No treatment medications were reported. Reporter left an incomplete phone number.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 032B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2001. Concurrent medical conditions included Hyperparathyroidism, Osteopenia and Tear film insufficiency, unspecified.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 10:38 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 10:38 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration). On 24-Jan-2022 at 10:38 AM, EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration) to be not related.    No concomitant and treatment products were reported. It was reported as per Moderna, the vaccine will maintain the necessary effectiveness against COVID-19. The reporter confirmed  that there were no other adverse events associated with this event. In addition Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered beyond 12 hours after first vial puncture; We had an excursion where product was administered 30 hours after the vial was punctured. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 12 hours after first vial puncture) and PRODUCT STORAGE ERROR (We had an excursion where product was administered 30 hours after the vial was punctured.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L218) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 5:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022 at 5:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 12 hours after first vial puncture) and PRODUCT STORAGE ERROR (We had an excursion where product was administered 30 hours after the vial was punctured.). On 20-Jan-2022 at 5:00 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 12 hours after first vial puncture) and PRODUCT STORAGE ERROR (We had an excursion where product was administered 30 hours after the vial was punctured.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided.  Reporter stated that the Moderna vial was taken out of the freezer and placed in the refrigerator on 18-JAN-2022. The vial was punctured on 19-JAN-2022 at 11:00 AM and the last dose was administered on 20-JAN-2022 at 5:00 PM. The punctured vial remained in the fridge.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-Nov-2021 and Low back pain. Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (Dose - 1, Batch/Lot no - J&J 1808609, ROA - IM, Arm and Volume - 0.5ml) on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26. Concurrent medical conditions included Drug allergy (Allergy to Codeine) and Sulfonamide allergy (Allergy to Sulfa).    On 24-Jan-2022 at 8:56 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jan-2022 at 8:56 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022 at 8:56 AM, EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant Medications were provided by the Reporter No treatment Information were provided by the Reporter   This case was linked to MOD-2022-473115 (Patient Link).   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; 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 or after manufacturer date of expiry) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No Treatment medication was reported.  On 03 Feb 2022 at 15:00 PM initially vial was stored in the refrigerator. Vial did not went under temperature excursion. On 04 Feb 2022 expired vaccine was given to patient. HCP was wanted to know next steps for correcting, that if she could revaccinate the patient and wanted information regarding  validity of doses.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: 12 weeks Pregnant; Last menstrual period on 1NOV2021 positive pregnancy test on 1DEC2021; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (12 weeks Pregnant; Last menstrual period on 1NOV2021 positive pregnancy test on 1DEC2021) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-Nov-2021 and the estimated date of delivery was 08-Aug-2022. On 04-Feb-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (12 weeks Pregnant; Last menstrual period on 1NOV2021 positive pregnancy test on 1DEC2021). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 04-Feb-2022, MATERNAL EXPOSURE DURING PREGNANCY (12 weeks Pregnant; Last menstrual period on 1NOV2021 positive pregnancy test on 1DEC2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Pregnancy test: positive (Positive) Pregnancy test was positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication reported. Patients last menstrual period was 01-Nov-2021.   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2022: Follow up received on 06-Feb-2022 and patient date of birth, Reporter's salutation, events updated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 047B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Erectile dysfunction. Concurrent medical conditions included Diabetes, Hypertension, Obesity, Hyperlipidaemia, Drug allergy (Allergy to Lisinopril), Drug allergy (Allergy to Irbesartan), Environmental allergy and Drug allergy (Allergy to atovaquone- proguanil). Concomitant products included GLIPIZIDE and METFORMIN for Diabetes, TESTOSTERONE for Erectile dysfunction, LOVASTATIN for Hyperlipidaemia, AMLODIPINE for Hypertension.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not reported.   Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired doses). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medications were provided.  The vial was initially stored in the refrigerator on 03 Feb 2022 at 3 PM.  The vial did not undergo any temperature excursions.  Reporter wanted to knowthe next steps for correcting the medication error and asked whether she should revaccinate the patients.  Reporter asked  information regarding validity of the doses.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      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.  Treatment information was not provided by the reporter.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  Reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided The expired booster shot administered after 30 day use by date or after manufacturer date of expiry.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter. No treatment given to patients.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 36 days after the first dose without receiving the second dose/her 1st and 2nd doses of the Moderna Covid-19 vaccines on 14Jul2021 and 29Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose/her 1st and 2nd doses of the Moderna Covid-19 vaccines on 14Jul2021 and 29Sep2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose/her 1st and 2nd doses of the Moderna Covid-19 vaccines on 14Jul2021 and 29Sep2021). On 29-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose/her 1st and 2nd doses of the Moderna Covid-19 vaccines on 14Jul2021 and 29Sep2021) had resolved.            The  concomitant medications on use were not provided. No treatment information was provided.  Patient was scheduled for her booster dose of Moderna COVID-19 vaccine on 29-Mar-2022 but she wanted to reset it on 28-Mar-2022 because clinic was open only on Mondays, Wednesdays, and Fridays.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The pharmacist reported about the administration of expired moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Amnesia, Magnetic resonance imaging, Scan brain
Clinical narrative: Amnesia/ Drove down the wrong side of a 4 lane highway during this time; Full 3rd dose (Not immunocompromised)/ But believes that he received a full dose for the 3rd dose of the vaccin; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Amnesia/ Drove down the wrong side of a 4 lane highway during this time) and ACCIDENTAL OVERDOSE (Full 3rd dose (Not immunocompromised)/ But believes that he received a full dose for the 3rd dose of the vaccin) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Full 3rd dose (Not immunocompromised)/ But believes that he received a full dose for the 3rd dose of the vaccin). On 13-Sep-2021, the patient experienced AMNESIA (Amnesia/ Drove down the wrong side of a 4 lane highway during this time). On 10-Sep-2021, ACCIDENTAL OVERDOSE (Full 3rd dose (Not immunocompromised)/ But believes that he received a full dose for the 3rd dose of the vaccin) had resolved. On 13-Sep-2021, AMNESIA (Amnesia/ Drove down the wrong side of a 4 lane highway during this time) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, Magnetic resonance imaging: normal (normal) could not find anything. On 13-Sep-2021, Scan brain: normal (normal) could not find anything.         No concomitant medications were provided. Patient stated that he was never given any medications or treatments for his symptoms.  Patient stated that he was not immunocompromised, he was a bus driver and drove down the wrong side of a 4 lane highway but  did not lost consciousness. On 13-Sep-2021 patient went to ER for testing of stroke and could not find anything. On 25-Oct-2021 patient went to a neurologist.  Patient also stated that symptoms did not occurred again since the one episode and was planned to return to work in several weeks.   This case was linked to MOD-2022-473269, MOD-2022-473284 (Patient Link).
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that the vaccines were stored in a freezer and one to 2 vials were taken and place in fridge each day as needed. It was reported that no treatment was given to the patients
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided. It was reported that the vaccine was stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.  No treatment information was provided.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in freezer, one to two vials were taken out and placed in the fridge each day as needed. No concomitant medications were reported.  No treatment was given.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No Treatment medications were reported
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication details reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer, took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  The reporter stated the administration of expired vaccine were given as booster shot to patient.  The vaccines were stored in freezer, they take out one or two vials and placed it in fridge each day as needed.  No treatment given on the patient.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Reporter stated that the vaccine was stored in freezer, and they take out one to two vials and place in fridge each day as needed.  Concomitant medication was not provided.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.   No treatment medication reported.  The vaccines was  stored in freezer, out one to two vials were taken out and placed in fridge each day as needed.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.   It was reported that the vaccine was stored in freezer, one of two vials were taken out and placed in fridge each day as needed.  No treatment given to the patient.