chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 12:13 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022 at 12:13 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.  Patient received the first, second, third and fourth dose of vaccine in Intramuscular deltoid muscle.  On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and vaccines were housed in these units. The manufactures were notified, and the department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions had been reported for the patient as per the reporter's knowledge.  No treatment medications were reported.
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.       For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient).    No concomitant medication was provided.  The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  On an unknown date, patient had received dose 1, dose 2, dose 3 of Moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.   Date vial was moved from freezer to refrigerator on 7-Sep-2022. The 2 unbroken cartons 20 vials.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: ; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The Moderna vaccines have undergone several temperature excursions and may have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      No concomitant medication was provided.  Patient received Dose 1 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The vaccine had undergone several temperature excursions and might got administered to patients.  The patient received Dose 2, Dose 3 and Dose 4 of Moderna vaccine intramuscular in deltoid muscle.  The vaccines were stored in the Refrigerator. There were 2 unbroken cartons with 20 vials. Date vial was moved from freezer to refrigerator on 07-Sep-2022. Vials were not visualized for Visual inspection.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted.    It was reported that no adverse reactions were reported to their knowledge for the patient.  Treatment medication was not provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 1:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 1:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medications were reported.   Dose 4 vaccine administered through deltoid.   The Nurse reports a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.     No information was available on that patients at this time.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient had received moderna vaccine doses 1, 2, and 3 intramuscularly and at the deltoid site of the body.  No treatment medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022 at 3:50 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 3:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.   Dose 4 vaccine administered through deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any of these patients.  The Nurse reports a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   The Nurse was now calling about Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   No information was available on that patients at this time.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient had received moderna vaccine doses 1, 2, and 3 intramuscularly and at the deltoid site of the body.  No treatment medications were reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Erection increased
Clinical narrative: Patient have got erection and its 3 hours now; This spontaneous case was reported by a patient and describes the occurrence of ERECTION INCREASED (Patient have got erection and its 3 hours now) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERECTION INCREASED (Patient have got erection and its 3 hours now). At the time of the report, ERECTION INCREASED (Patient have got erection and its 3 hours now) outcome was unknown.     No concomitant medications was provided. It was reported that, Patient had a hard time, got the vaccine and sound crazy but had got a reaction.  Patient also stated had got erection and its 3 hours prolonged. No treatment medications was provided.   Reporter did not allow further contact
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccines had undergone several temperature excursions and administered to patient; No adverse event; Vaccines had undergone several temperature excursions and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with or tested positive for COVID-19.     On 04-Aug-2022 at 6:18 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Aug-2022 at 6:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient).    No concomitant medication was provided.  Patient received Dose 1 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The vaccine had undergone several temperature excursions and might got administered to patients.  The patient received Dose 2, Dose 3 and Dose 4 of Moderna vaccine intramuscular in deltoid muscle.  The vaccines were stored in the Refrigerator. There were 2 unbroken cartons with 20 vials. Date vial was moved from freezer to refrigerator on 07-Sep-2022. Vials were not visualized for Visual inspection.  It was reported that refrigeration excursions identified, vaccine was housed in these units. There were excursions noted.    It was reported that no adverse reactions were reported to their knowledge for the patient.  Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old vaccine instead of the 12 plus vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old vaccine instead of the 12 plus vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old vaccine instead of the 12 plus vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant product use was reported.  The patient received Booster dose.  It was reported by the reporter that the facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures. At the time of excursion, the products were in frozen storage as unbroken cartons. However, the excursion duration and temperature were unknown.  Both vial sizes of 2.5ml and 5.5ml were affected.  At the time of report the product was returned to the freezer.  It was further reported that the patient was administered the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine.  No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022 at 6:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 24-Sep-2022 at 6:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant product reported by the reporter.  Patient had previously received dose 1 , dose 2 and dose 3 of Moderna vaccine in the intramuscular route at the deltoid body site. Patient received dose 4 of Moderna vaccine in deltoid.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial(s) moved from freezer to refrigerator was on 07 Sep 2022.  No adverse reactions experienced by the patient. It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  No treatment medication reported by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Vaccines have undergone several temperature excursions and may have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Allergies to medications, food and other products were reported as not applicable. It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.     On 21-Sep-2022 at 6:09 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Sep-2022 at 6:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient).    No concomitant medication was reported.  Refrigeration excursions was identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department and made aware of the situation.  Vaccines stored in refrigerator underwent several temperature excursions going back to Aug-2022.  Patient received vaccine in deltoid. Product dose/ volume was reported as 0.5.  No adverse reactions reported for the patient.  No treatment medication was reported.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.       For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients).    Concomitant medication information was not provided.  It was unknown patient had been ever diagnosed with or tested positive for COVID-19.  On an unknown date, patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   On 07 Sep 2022 vials moved from freezer to refrigerator.  It was reported that no adverse reactions were reported to their knowledge for any patients.  No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 21-Sep-2022 at 12:30 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 21-Sep-2022 at 12:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medication was provided.  On an unknown date, patient had received dose 1, dose 2, dose 3 of moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.     Treatment medication was not provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient ever tested positive for COVID-19.     On 26-Sep-2022 at 2:10 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Sep-2022 at 2:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022).    Concomitant medication information was not provided.  It was reported that the bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to Aug-2022.  The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle.  The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle and no adverse reactions were reported.  No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions; No adverse event; Vaccines have undergone several temperature excursions and may have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022 at 6:56 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 24-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient).    Concomitant medication information was not provided. The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle and no adverse reactions were reported. No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 1:07 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022 at 1:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Concomitant medication information was not provided. Refrigeration excursions identified. The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received 0.5 (units not specified) as fourth dose of vaccine on deltoid muscle and no adverse reactions were reported. No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 2:45 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient ever tested positive for COVID-19.     On 17-Sep-2022 at 4:18 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 17-Sep-2022 at 4:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Concomitant medication information was not provided. The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle and no adverse reactions were reported. No treatment information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED Doses of Modern ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71468) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 12:02 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 26-Sep-2022 at 12:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         Concomitant medications details were not reported by the reporter. Anatomical location for vaccine administration was reported as deltoid.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. On 07 Sep 2022 vials moved from freezer to refrigerator. The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle. It was unknown patient had been ever diagnosed with or tested positive for COVID-19. Treatment details was not reported by the reporter
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with poor quality product), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.       Concomitant medications details were not reported by the reporter.  Anatomical location for vaccine administration was reported as deltoid.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients.  On 07 Sep 2022 vials moved from freezer to refrigerator.  The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle.  The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle.  No adverse reactions reported to our knowledge for any of these patients.  It was unknown patient had been ever diagnosed with or tested positive for COVID-19.  Treatment details was not reported by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.     On 24-Sep-2022 at 6:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Sep-2022 at 6:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant product reported by the reporter. Patient received 0.5 (units unspecified) of Bivalent vaccine in deltoid. Patient had received previous 3 doses of COVID-19 vaccine, intramuscular with anatomical site as deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in the units. There were excursions noted. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported to their knowledge for the patient. No treatment medication reported by the reporter.