chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. A medical assistant reports that they had temperature excursions involving 4 Moderna Covid-19 vaccines inside the refrigerator on 28 Jan-30 Jan2022, 31Jan2022 and 04Feb2022. The impacted vaccines were administered to 40 patients on unspecified dates.No patients have reported any adverse events to date.The vial was thawed on 28 Jan 2022. The vials had Maximum or minimum temperatures reached,on 28 Jan 2022 temp range positive 34.7F to positive 41.2F, on 30 Jan 2022 temp range positive 34.7F to positive 41.2F which occurred approximately for 48 hours, on 31 Jan 2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04 Feb 2022 temp range positive 35.2F to positive 41.7F for 12 hours. No treatment drug details was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: patient felt tired/did not want to do anything; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (patient felt tired/did not want to do anything) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (patient felt tired/did not want to do anything). At the time of the report, FATIGUE (patient felt tired/did not want to do anything) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient experienced no side effects after the first Moderna Covid-19 vaccine.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-535793 (Patient Link).
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered with vaccine that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient administered with vaccine that have undergone temperature excursion) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered with vaccine that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient administered with vaccine that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered with vaccine that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient administered with vaccine that have undergone temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. No patients have reported any adverse events to date. Vaccines were thawed on 28-Jan-2022. It was reported that 2 vials with lot number 059H21A had expiration date of 27-Mar-2022. It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. Treatment information was not reported. This case was linked to MOD-2022-539812 (Patient Link).
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen (Dose-1) on 21-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 30-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter reported that that they had temperature excursions involving 4 Moderna Covid-19 vaccines inside the refrigerator on four dates. The impacted vaccines were administered to 40 patients. No patients have reported any adverse events to date.   The storage condition at the time of the excursion was refrigerator. The lot number was 059H21A with expiration date 27-Mar-2022. The maximum or minimum temperatures reached on 28-Jan-2022 temp range was positive 34.7F to positive 41.2F; on 30-Jan-2022 temp range was positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31-Jan-2022 temp range was positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range was positive 35.2F to positive 41.7F for 12 hours. The date the vial moved from freezer to refrigerator was not available. It was also reported that all the vaccines were administered. All 4 vials were administered, they were thawed because they were in the refrigerator. The proposed desired Use by Date was 0 not applicable. The vial was thawed on 28-Jan-2022.  No treatment information was provided.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered with vaccines that have undergone temperature excursion; patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported It was reported that only lot number: 059H21A was affected and it was first thawed on 28-Jan-2022 It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. No Treatments were reported   This case was linked to MOD-2022-540806.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose1) on 22-May-2021 and COVID-19 Vaccine (Dose 2) on 20-Jun-2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine.    On 04-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. Vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022. Patient had received booster dose of Moderna vaccine. Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: refrigerator Temperature excursions involving 4 Moderna Covid-19 vaccines inside the refrigerator on 28Jan-30Jan2022, 31Jan2022 and 04Feb2022. On 28 Jan 2022 Maximum or minimum temperatures reached range was positive 34.7F to positive 41.2F, on 30 Jan 2022 temperature range was positive 34.7F to positive 41.2F which occurred approximately for 48 hours, on 31 Jan 2022 temperature range was positive 34.7F to positive 41.2F for 12 hours and on 04 Feb 2022 temperature range was positive 35.2F to positive 41.7F for 12 hours. No patient had reported any adverse events. The reporter wants to know if the patients need to be re-vaccinated. No treatment drug information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Caller may have gotten the second booster dose before authorized time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller may have gotten the second booster dose before authorized time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052F21A, 043B20A and 337K21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller may have gotten the second booster dose before authorized time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller may have gotten the second booster dose before authorized time) outcome was unknown.            As per the event verbatim it was stated that patient had taken second booster dose on 02-FEB-2021 , which is a discrepant information, because 1st booster was given on 01-NOV-2021, if that is the case then second booster should be given after NOV-2021.  No concomitant medications were reported  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow up received contained NNI- No New Information.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered vaccines that have undergone temperature excursion; Patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that only lot number: 059H21A was affected and it was first thawed on 28-Jan-2022 It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours.  No treatments were reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 on 29-Jan-2021 and dose 2 on 05-Feb-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 29-Jan-2021 and dose 2 on 05-Feb-2021) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 29-Jan-2021 and dose 2 on 05-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 29-Jan-2021 and dose 2 on 05-Feb-2021) outcome was unknown.        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.   This case was linked to MOD-2022-540720 (Patient Link).
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported It was reported that only lot number: 059H21A was affected and it was first thawed on 28-Jan-2022 It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. No Treatments were reported.   This case was linked to MOD-2022-540883 (Patient Link).
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates; temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they had temperature excursions involving 4 Moderna COVID-19 vaccines inside the refrigerator on 28-Jan2022 to 30-Jan-2022, 31-Jan-2022 and 04-Feb-2022. The impacted vaccines were administered to the patients.  Storage condition at the time of the excursion was refrigerator. Maximum or minimum temperatures reached and excursion duration were on 28-Jan-2022 temp range: positive 34.7 Fahrenheit (F) to positive 41.2 F; on 30-Jan-2022 temp range: positive 34.7 F to positive 41.2 F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temp range: positive 35.2 F to positive 41.7 F for 12 hours. Date the vials were moved from freezer to refrigerator were not available. As per the reporter the vaccines were thawed on 28-Jan-2022 because they were in the refrigerator.  The patient did not report any adverse events.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: A patient was administered a dose from a vial that had been open for 22 h; A patient was administered a dose from a vial that had been open for 22 h; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose from a vial that had been open for 22 h) and PRODUCT STORAGE ERROR (A patient was administered a dose from a vial that had been open for 22 h) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 3:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose from a vial that had been open for 22 h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (A patient was administered a dose from a vial that had been open for 22 h). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose from a vial that had been open for 22 h) and PRODUCT STORAGE ERROR (A patient was administered a dose from a vial that had been open for 22 h) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient received booster dose. It was reported that the vial went from the freezer to thawing process at room temperature on13-Apr-2022 at 05:00 pm, (thawing process 2 h) and was first punctured at 13-Apr-2022 at 07:00 pm.  No temperature excursion occurred and vials were stored in room temperature for 22 hours.  The expiry date of the vial was reported as 20-May-2022.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients administered with vaccines that have undergone temperature excursion; patients administered with vaccines that have undergone temperature excursion; Second dose on 10-Sep-2021 and booster dose on 30-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 10-Sep-2021 and booster dose on 30-Jan-2022) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 10-Sep-2021 and booster dose on 30-Jan-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 10-Sep-2021 and booster dose on 30-Jan-2022) 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.  Vaccines were thawed on 28-Jan-2022.  It was reported Maximum or minimum temperatures reached as applicable  on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours No patients have reported any adverse events to date. No treatment medication information was given.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Administered dose with the temperature excursion issue; Inappropriate schedule of vaccine administered; Administered dose with the temperature excursion issue; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered dose with the temperature excursion issue), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered dose with the temperature excursion issue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered dose with the temperature excursion issue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administered dose with the temperature excursion issue). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered dose with the temperature excursion issue), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered dose with the temperature excursion issue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Only lot number 059H21A, thawed on 28-Jan-2022 was affected lot 084J21A was not put into use until 10-Feb-2022. On 28-Jan-2022 temp ranged from 34.7F to 41.2F, on 30-Jan-2022 34.7F to 41.2F which occurred approximately for 48 hours; on 31-Jan-2022 34.7F to 41.2F for 12 hours and on 04-Feb-2022 35.2F to 41.7F for 12 hours.  No treatment medication was reported by reporter.  No patient reported any adverse event.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 on 22-Jun-2021 and dose 2 on 04-Aug-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 22-Jun-2021 and dose 2 on 04-Aug-2021) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 22-Jun-2021 and dose 2 on 04-Aug-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 22-Jun-2021 and dose 2 on 04-Aug-2021) 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 provided.   This case was linked to MOD-2022-540807 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022; 4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 076C21A, 008C21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease, Hypertension and Hyperlipidemia.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter confirmed that no adverse events were reported.  No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Wrong technique in product usage process
Clinical narrative: Sick for 30 hours; Sore arm; little bit of the needle was left out/didn't go all the way into the arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 30 hours), PAIN IN EXTREMITY (Sore arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (little bit of the needle was left out/didn't go all the way into the arm) 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for 30 hours), PAIN IN EXTREMITY (Sore arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (little bit of the needle was left out/didn't go all the way into the arm). At the time of the report, ILLNESS (Sick for 30 hours), PAIN IN EXTREMITY (Sore arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (little bit of the needle was left out/didn't go all the way into the arm) outcome was unknown.            No Concomitant product use was reported.  The patient went for a Moderna fourth shot and was concerned that vaccine technician didn't go all the way into the arm and said that a little bit of the needle was left out. The patient stated that they did not look at the administration of their vaccine. The patient reported that they had a sore arm after fourth dose and also stated that the patient was sick after the booster dose sick for 30 hours.  No treatment information was provided.   Reporter did not allow further contact
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: fever 99-100F; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 99-100F) and MYALGIA (body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0141L20A) for COVID-19 vaccination.     The patient's past medical history included Small intestine carcinoma (Diagnosed in the past 3-4 years. Cancer tumors in the small intestines was removed.). Concurrent medical conditions included Type 2 diabetes mellitus and Pancreatic carcinoma (Diagnosed in the past 3-4 years. It was still there and being investigated.).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (fever 99-100F) and MYALGIA (body aches). On 20-Jan-2021, PYREXIA (fever 99-100F) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 99-100f 99-100F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  The patient did not had any history of allergies and history of COVID-19 prior to or after getting the vaccine. He was not undergoing any chemotherapy.  The patient had had fever and body aches after getting the 1st and 2nd doses and the 1st booster dose of the Moderna Covid-19 vaccine. He also stated that on all occasion he had fever and body aches the day after the vaccination which lasted for a day or two. After the first dose he had fever which was 99-100.  The patient received shingles vaccine first dose on 12-Oct-2021 and the second dose on 06-Apr-2022.  No treatment information was reported.   This case was linked to MOD-2022-541327, MOD-2022-541328 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Followup received with QE number added.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever very high) and MYALGIA (Body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 0141L20A) for COVID-19 vaccination. He did not have any history of allergies and history of COVID-19 prior to or after getting the vaccine. The patient's past medical history included Small intestine carcinoma (Had cancer tumors in the small intestines which were removed). Concurrent medical conditions included Pancreas cancer (Has cancer tumors in the pancreas which was still there and still being investigated) and Type 2 diabetes mellitus. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PYREXIA (Fever very high) and MYALGIA (Body aches). On 15-Feb-2021, PYREXIA (Fever very high) and MYALGIA (Body aches) had resolved. It was reported that the patient had both the cancers which were diagnosed in the past 3-4 years and the patient was not undergoing any chemotherapy,  No concomitant medications were reported. It was mentioned that the patient experienced very high fever after 2nd dose when compared to 1st dose and 1st booster dose which was just 99-100. The patient received shingles vaccine first dose on 12-Oct-2021 and the second dose on 06-Apr-2022. No treatment medications were reported. This case was linked to MOD-2022-541321, MOD-2022-541328 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow up received and QE number added.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Fever 99-100 F; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 99-100 F) and MYALGIA (Body aches) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 002M21A, 030M20A and 0141L20A) for COVID-19 vaccination.     The patient does not have any history of allergies and history of COVID-19 prior to or after getting the vaccine.  The patient's past medical history included Small intestinal neoplasm (Has cancer tumors in the small intestines which were removed). Concurrent medical conditions included Type 2 diabetes mellitus and Pancreas cancer (Has cancer tumors in the pancreas which were still there and still being investigated).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced PYREXIA (Fever 99-100 F) and MYALGIA (Body aches). On 30-Oct-2021, PYREXIA (Fever 99-100 F) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Body temperature: 99-100 (High) 99-100 F.         It was reported that the patient had both the cancers which were diagnosed in the past 3-4 years and the patient was not undergoing any chemotherapy. Co-suspect medication information included that the patient had the shingles vaccine and those were given at a clinic, the first dose of which was on 12-Oct-2021 and the second dose was on 06-Apr-2022. It was asked by the patient that if there was a way to determine if the vaccine that the patient received for his second booster dose was a real vaccine or not as the patient had not experienced any side effects post vaccination. In fact, the patient mentioned that he was more upbeat and energetic. The patient was wondering because he had fever and body aches after getting the first booster dose of the Moderna COVID-19 vaccines and included the 2 doses of shingles vaccine. The patient was told by the vaccine provider that the patient was given half dose for the two booster doses. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-541327, MOD-2022-541321 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow up received includes no new significant information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Aching; Strong chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), CHILLS (Strong chills) and PYREXIA (Fever) 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aching), CHILLS (Strong chills) and PYREXIA (Fever). At the time of the report, PAIN (Aching), CHILLS (Strong chills) and PYREXIA (Fever) had not resolved.            Patient received 2nd Moderna covid19 vaccine booster dose.   Concomitant medications were not reported. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dispensed 28 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that they dispensed 28 doses of expired Moderna Covid-19 vaccine. These were administered on 06Apr2022 & 08Apr2022 with Lot: 012H21B and expiration date:18Mar2022.  No concomitant medications were reported  No treatment medications were reported