chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that 21 patients received vaccine past the 30 days beyond use date after the vaccine was placed in the refrigerator on 24-Jan-2022 Moderna Covid-19, Lot Number 030H21B, Expiration Date-23-Mar-2022 for all patients involved.  It was reported that the first 9 patients received Moderna Covid-19 vaccine on 02-Mar-2022 past its 30 days Beyond Use Date. The patient received Moderna Covid-19 vaccine on 02-Mar-2022 wt. was not known, expiration date 20-Mar-2022. The reporter also mentioned that they didn't know which dose the patient received the invalid dose on and didn't know which arm the patient received the Moderna Covid-19 vaccine in. The reporter doesn't have any other adverse events or side effects to report.  Reportedly, the reporter wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022. The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24-Jan-2022. It was also reported that the vial didn't undergo any temperature excursions.  No treatment information was provided.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The facility received the vaccine in October 2021. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Moderna the expiration date 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program on Moderna that showed the expiration date as 14-Oct-2022. The PC number was reported as 16069. It was reported that the vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a Moderna COVID-19 vaccine Booster dose after 12 hours post punctured; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a Moderna COVID-19 vaccine Booster dose after 12 hours post punctured) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 12-Mar-2022 at 1:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Mar-2022 at 1:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a Moderna COVID-19 vaccine Booster dose after 12 hours post punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a Moderna COVID-19 vaccine Booster dose after 12 hours post punctured) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter did not know if the patient had any allergies or tested positive for COVID-19 or received any other vaccine within 1 month prior to Moderna. The reporter did not know if the patient had any acute or chronic illnesses.  The reporter did not know if the patient was taking any concomitant medication.  The reporter did not have any information about the first 3 doses or manufacturer of the COVID-19 vaccine for the patient.  The vial was initially stored in the refrigerator was on 09-Mar-2022. The vial was first punctured on 11-Mar-2022 on 15:13 pm. The vial was stored in room temperature post puncture and the vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius = 46 degree to 77-degree Fahrenheit) was 22 hours. The reporter confirmed that the patient received the booster dose in her deltoid muscle and also the reporter did not know if the patient was experiencing any symptoms.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-512464 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a Moderna Covid-19 vaccine Booster dose more than 12 hours post punctured; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine Booster dose more than 12 hours post punctured) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 12-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine Booster dose more than 12 hours post punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine Booster dose more than 12 hours post punctured) outcome was unknown.            Patient took Moderna vaccine on deltoid muscle. No concomitant and treatment  medication was reported by the reporter.   This case was linked to MOD-2022-512457 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse said that the patient had a screenshot of the lot number entered into the lot number expiration date check that shows the expiration date as 14-Oct-2022. The vial did not undergo any temperature excursions. No concomitant and treatment medication were provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) outcome was unknown.        For mRNA-1273 (Spikevax) (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.  The Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.The Pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022. The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24-Jan-2022.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial did not went under any temperature excursion.   Treatment information was not provided by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 24-Jan-2022, vial was transferred from the Freezer to the refrigerator and initially stored in it. The vial did not undergo temperature excursion.The Pharmacist does not have any other adverse events or side effects to report.  No treatment medication information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever after second dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced PYREXIA (fever after second dose). In June 2021, PYREXIA (fever after second dose) had resolved.            No concomitant drug was reported.  It was reported that the patient received her first vaccination with no side effects, in early May.  No treatment medications were reported.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022.  No treatment information was provided.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that vaccine that shows as expired 14-Aug-2021 but also expired on 14-Oct-2022.  No concomitant medication and treatment drug were reported
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that dose administered after 30-day Use By date or after manufacturer date of expiry. No temperature excursions were noted at any time during the administration of the vaccine. Total number of doses was 5.  No treatment medication were provided.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14 Aug 2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14 Oct 2022. The vial did not undergo any temperature excursions. No treatment drugs were reported.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter was calling regarding a lot number of vaccine that a facility in their health care system received in Oct-2021. The Lot number of the vaccine was 010A21A. The Nurse said that 5 patients received the expired vaccine and that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The Nurse said that they had a screenshot of the above lot number 010A21A entered into the lot number expiration date look up program on Modernatx.com that showed the expiration date as 14-Oct-2022.  The dose was administered after 30-day Use by Date or after manufacturer date of expiry. The date of administration of vaccine was 02-Feb-2022. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was provided.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        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 information was provided by the reporter. It was reported that vaccine that shows as expired August 14, 2021 but also expired on October 14, 2022.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Anorectal discomfort, Anorectal disorder, Fall, Frequent bowel movements, Pruritus
Clinical narrative: His anus was activated,Nerves in his anus are not working properly; Anal problems, Went to nursing home temporarily because he fell, He always has to potty all the time; Kept feeling like he had to have a bowel movement,He went to bathroom about 14 times day,First he was going every hour now it's every 3 hours; Went to nursing home temporarily because he fell; Itching really bad; This spontaneous case was reported by a consumer and describes the occurrence of ANORECTAL DISORDER (His anus was activated,Nerves in his anus are not working properly), ANORECTAL DISCOMFORT (Anal problems, Went to nursing home temporarily because he fell, He always has to potty all the time), FREQUENT BOWEL MOVEMENTS (Kept feeling like he had to have a bowel movement,He went to bathroom about 14 times day,First he was going every hour now it's every 3 hours), FALL (Went to nursing home temporarily because he fell) and PRURITUS (Itching really bad) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) (Had a pacemaker) in 2020. Concurrent medical conditions included Heart disease, unspecified (Heart patient).    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANORECTAL DISORDER (His anus was activated,Nerves in his anus are not working properly), ANORECTAL DISCOMFORT (Anal problems, Went to nursing home temporarily because he fell, He always has to potty all the time), FREQUENT BOWEL MOVEMENTS (Kept feeling like he had to have a bowel movement,He went to bathroom about 14 times day,First he was going every hour now it's every 3 hours), FALL (Went to nursing home temporarily because he fell) and PRURITUS (Itching really bad). At the time of the report, ANORECTAL DISORDER (His anus was activated,Nerves in his anus are not working properly), ANORECTAL DISCOMFORT (Anal problems, Went to nursing home temporarily because he fell, He always has to potty all the time), FREQUENT BOWEL MOVEMENTS (Kept feeling like he had to have a bowel movement,He went to bathroom about 14 times day,First he was going every hour now it's every 3 hours), FALL (Went to nursing home temporarily because he fell) and PRURITUS (Itching really bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. The patient had to go to nursing home temporarily because he fell and it was reported that came back at the time of reporting. No treatment medication were provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported.
Age: 60.0
Sex: U
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 a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that when the lot number of Moderna Covid-19 vaccine of 010A21A is entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021.  Reporter also had a screenshot of the above lot number 010A21A entered into the lot number expiration date look up program on Modernatx.com that shows the expiration date as 14-Oct-2022.The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine is given more than 30 days from storage and is expired/the vaccine was placed in the refrigerator on 24JAN2022; Pharmacy gave Moderna COVID-19 vaccine past its 30 day beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 day beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine is given more than 30 days from storage and is expired/the vaccine was placed in the refrigerator on 24JAN2022) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 day beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is given more than 30 days from storage and is expired/the vaccine was placed in the refrigerator on 24JAN2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 day beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine is given more than 30 days from storage and is expired/the vaccine was placed in the refrigerator on 24JAN2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on 24-JAN-2022. The vial did not undergone any temperature excursions. The Pharmacist does not know which dose this patient received the invalid dose on and wrote an expiration date of 24-MAR-2022 on the Moderna COVID-19 vaccine instead of 24-FEB-2022. No Concomitant information was reported. No Treatment information was reported. The Pharmacist did not have any other adverse events or side effects to report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 15-Mar-2022; Patient was administered Moderna COVID-19 dose after the 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 dose after the 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 15-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 dose after the 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 15-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 dose after the 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 15-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that, the vial was initially stored in the refrigerator on 08-Feb-2022 and vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 5 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14 Aug 2021. The nurse said that she had a screenshot of the above lot number 010A21A entered the lot number expiration date check program that shows the expiration date as 14 Oct 2022.  Date the vial was initially stored in the refrigerator was not provided and the vial did not undergo any temperature excursions.  No treatment drugs were reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was placed in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022; The pharmacy gave Moderna COVID-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was placed in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was placed in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was placed in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported.  The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna COVID-19 vaccine instead of 24-Feb-2022. The Moderna COVID-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022. The vial did not undergo any temperature excursions. The reporter did not know which dose the patient was received. The reporter did not have any other adverse events or side effects to report for the patient.  No treatment information was provided by the reporter.
Age: 76.0
Sex: U
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 a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that when the lot number of Moderna Covid-19 vaccine of 010A21A is entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021.  Reporter also had a screenshot of the above lot number 010A21A entered into the lot number expiration date look up program on Modernatx.com that shows the expiration date as 14-Oct-2022.The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 10 Mar 2022; Pharmacy gave Moderna Covid-19 vaccine past its 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 days beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 10 Mar 2022) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 10 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 days beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 10 Mar 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that the patient received vaccine past the 30 days beyond use date after the vaccine was placed in the refrigerator on 24-Jan-2022. The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022. The reporter does not know which dose the patient received and on which arm the patient received the Moderna Covid-19 vaccine. No other adverse events or side effects were reported. Vial did not undergo any temperature excursion.  Treatment medications were not reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 26 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  Vaccine was administered on 19-Aug-2021, 2-Feb-2022, 2-Mar-2022  The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022.  No treatment medications was provided by the reporter.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to patient) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to patient) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The vial was initially stored in the refrigerator was on 24-Jan-2022. The Pharmacist wrote an expiration date of 24-MAR-2022 on the Moderna Covid-19 vaccine instead of 24-FEB-2022. Vial did not undergo any temperature excursions.  The Pharmacist did not have any other adverse events or side effects to report.  No treatment medications were provided by the reporter.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired vaccine administered; First dose on 11 Feb 2022 and second dose on 02 Mar 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11 Feb 2022 and second dose on 02 Mar 2022) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11 Feb 2022 and second dose on 02 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11 Feb 2022 and second dose on 02 Mar 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Lingering aches and pain since receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lingering aches and pain since receiving the 1st dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN (Lingering aches and pain since receiving the 1st dose). At the time of the report, PAIN (Lingering aches and pain since receiving the 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant product was provided by the reporter.   It was reported that the patient went to the doctor in Nov-2020 for a check-up and was not having any pain.  No treatment medication was provided.   This case was linked to MOD-2022-512683, MOD-2022-512678 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Runny nose; Foot pain; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Foot pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Foot pain). At the time of the report, RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Foot pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.