chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
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 (vaccines undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 66-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 21-Sep-2022 at 12:59 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 12:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) 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 (vaccines undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    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.
Age: 23.0
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 (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 23-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 24-Sep-2022 at 3:12 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 3:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and 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 (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) 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 (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    Concomitant medication information was not provided.  The nurse reported about Moderna monovalent and bivalent vaccines that 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.  No adverse reactions had been reported for the patient as per the reporter's knowledge.  No treatment information was provided.
Age: 31.0
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 (Refrigeration excursions identified/Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 31-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 had ever been diagnosed with COVID-19 or tested Positive for COVID-19.     On 23-Sep-2022 at 3:19 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 23-Sep-2022 at 3:19 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 (Refrigeration excursions identified/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 (Refrigeration excursions identified/Bivalent vaccines have undergone several temperature excursions and 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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    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.
Sex: M
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 WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       Concomitant medications were not reported.  The patient received booster dose of Moderna vaccine.    Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.
Age: 4.0
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 (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2022 at 3:54 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 25-Aug-2022 at 3:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         Dose 1 vaccine administered in deltoid region. 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 were reported. The nurse reported that temperature excursion that had occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines had that underwent several temperature excursions going back to August 2022.  It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19.  Treatment Medication use information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age 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 (Patient received the Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus 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 (Patient received the Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
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 (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.     Concomitant product use was not provided by the reporter.  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 the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 mL and 5.5 mL.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  Treatment information was not provided.
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Facility had a temperature excursion in the freezer; Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) 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)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion).    No concomitant medications were reported.   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 the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 ml and 5.5 ml.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion; Facility had a temperature excursion in the freezer; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No Adverse Event) 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)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) 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)) (Unknown), 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 received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer).    No concomitant medications were reported.  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 the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 ml and 5.5 ml. Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer. The visual inspection showed the vaccine state as still frozen. The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
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 another health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature) 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)) (Unknown), 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 received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature).    No concomitant medications were reported.  I The vial undergo temperature excursion for the first time and patients were involved. Total 40 patients were involved who received Monovalent and Bivalent doses after excursion. No treatment details were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Facility had a temperature excursion in the freezer; Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion).    No concomitant medication was reported.    At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 mL and 5.5 mL.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; Refrigeration excursions identified; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) 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. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022, 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 an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration 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 did not provide any causality assessments.   No concomitant medication information was reported.  The patient received three doses of Moderna Covid 19 vaccine (Dose1, dose2 and dose3) on an unknown date intramuscularly in deltoid.  No treatment medication information was reported.  Refrigeration excursions identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department and made aware of the situation. No adverse reactions reported to our knowledge for any of these patients.  The nurse reported a temperature excursion that had occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines had undergone several temperature excursions and may had been administered to patients.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Bivalent vaccination after a temperature excursion; Patients received the Bivalent vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion).    Concomitant product use was not provided by the reporter.  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 the excursion, the vaccine was in frozen storage. The vaccines were in unbroken cartons with vial size of 2.5 ml and 5.5 ml.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.  The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  The patient had received the booster dose of Moderna COVID-19 vaccine, Bivalent.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified/undergone several temperature excursions; No adverse event; vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 74-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 4:57 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 4:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients) 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/undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients).    No concomitant medications were reported. It has been identified that there were two unbroken cartons out of 20 vials. The patient received previous three doses of vaccine intramuscular in deltoid. Suspect bivalent vaccine (Dose 4) anatomical location was reported as deltoid. It was unknown if the patient had ever tested or been diagnosed with COVID-19. Vials were moved from freezer to refrigerator on 07-Sep-2022. It was reported that the vaccines had undergone several temperature excursions in Aug-2022. Refridgeration excursions identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department made aware of the situation. No adverse reactions reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient experienced reactions; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient experienced reactions) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient experienced reactions). At the time of the report, IMMUNISATION REACTION (Patient experienced reactions) outcome was unknown. Not Provided   Concomitant product use was not provided by the reporter.   On 26-Oct-2022 it was reported that patient started treatment on an unspecified date with Moderna COVID-19 vaccine at dose 2 for COVID-19 immunization.  Treatment information was not provided.   Reporter did not allow further contact
Age: 79.0
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 (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event) in a 79-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 PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients).    No concomitant medications were reported.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient took 1, 2, and 3 doses intramuscularly and at the deltoid site of the body.  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.    No treatment medications were reported.
Age: 88.0
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 (Vaccine has undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine has undergone several temperature excursions and may have been administered to patient.) and NO ADVERSE EVENT (No adverse event) in an 88-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 had ever been diagnosed or tested positive for COVID-19.     On 16-Sep-2022 at 1:57 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 16-Sep-2022 at 1:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine has undergone several temperature excursions and may have been administered to patient.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine has undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine has undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine has undergone several temperature excursions and may have been administered to patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant medications were reported. The patient received previous three doses of vaccine intramuscular in deltoid. For Dose 4 anatomical location was reported as deltoid with concentration 0.5 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 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 for the patient. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. No treatment products reported.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; 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 (Refrigeration excursions identified/vaccines have undergone several temperature excursions) 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.     No Medical History information was reported.    On 15-Sep-2022 at 3:26 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 3:26 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 (Refrigeration excursions identified/vaccines have undergone several temperature excursions) 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 (Refrigeration excursions identified/vaccines have undergone several temperature excursions) 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 (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.   It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  The vial(s) moved from freezer to refrigerator on 07-Sep-2022.   It was reported that the vaccines had undergone several temperature excursions in Aug 2022.   Refrigeration excursions were identified, vaccine was housed in the units. There were excursions noted. Manufactures were notified and the department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment information was provided.
Age: 74.0
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 (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 74-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 had ever been diagnosed or tested positive for COVID-19.     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) 1 dosage form. On 21-Sep-2022 at 1:51 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 (Vaccine have undergone several temperature excursions and was administered to the patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration 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 (Vaccine have undergone several temperature excursions and was administered to the patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified).    No concomitant medications were reported.  Vaccination site was deltoid muscle. Dose/volume reported 0.5.    No treatment medications were reported.