chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo any temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly 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 (the vial undergo any temperature excursion) 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 (the vial undergo any 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo any 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 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.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients 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 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.    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 (Patients 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 (Patients 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 (Patients received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature).    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: Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination 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 immunisation.     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 (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the 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 POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion).    No concomitant medications were reported.  Patient received Bivalent booster dose.  It was reported that the facility had a temperature excursion in the freezer, the DDL was not recording the temperatures. Storage condition at the time of excursion was Frozen storage. Unbroken cartons of vial size 2.5 and 5.5 ml were involved. Excursion duration was not known. Vials were returned to freezer and were still frozen. Visual inspection state was still frozen. Maximum or minimum temperature reached was unknown and only had manual twice a day recording and duration of excursion was unknown.  No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Received the vaccination after a temperature excursion; The facility had a temperature excursion in the freezer/ received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The facility had a temperature excursion in the freezer/ received the vaccination 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 POOR QUALITY PRODUCT ADMINISTERED (Received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The facility had a temperature excursion in the freezer/ received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The facility had a temperature excursion in the freezer/ received the 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 POOR QUALITY PRODUCT ADMINISTERED (Received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (The facility had a temperature excursion in the freezer/ received the vaccination after a temperature excursion).    No concomitant medication 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 vaccine was in frozen storage. Unbroken Cartons with vial size of 2.5 mL and 5.5 mL. Maximum or minimum temperatures reached was unknown, only had manual twice a day recording. The excursion duration was Unknown. The vials were Returned to the freezer at the time of reporting. Upon visual inspection vaccine state change was still frozen.  No treatment information was provided by the reporter.
Age: 26.0
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 that underwent temperature excursions, administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions, administered to patient) and NO ADVERSE EVENT (No adverse event) in a 26-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 17-Sep-2022 at 2:50 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Sep-2022 at 2:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions, administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions, administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions, administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions, 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 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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refrigeration excursions identified/undergone 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/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 71-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 that the patient ever been diagnosed with/ tested positive for COVID-19.     On 25-Sep-2022 at 12:49 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 25-Sep-2022 at 12:49 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.        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/undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patient).    No concomitant products reported.  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. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. The body site was mentioned as deltoid for administration.  No adverse reactions reported for the patient.  No treatment products reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: vaccine that underwent temperature excursions could have been administered to patient; No adverse event; vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 67-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 2:36 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 22-Sep-2022 at 2:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could 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 (vaccine that underwent temperature excursions could have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient).    Patient received vaccine in deltoid.  No concomitant product reported by the reporter.  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 medication reported by the reporter.
Age: 44.0
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 (Bivalent vaccines have undergone several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 44-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 12:42 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 12:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) 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 may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant products reported.  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. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. The body site was mentioned as deltoid. The previous doses route and body site was reported as intramuscular and deltoid.  No adverse reactions reported for the patient.  No treatment products reported.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 04-Aug-2022 at 5:03 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Aug-2022 at 5:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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 (vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (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 (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 PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and have been administered to patient).    Patient received vaccine in deltoid.  Concomitant medication list was not provided. It was reported that refrigeration excursions identified, vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022.state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation No adverse reactions reported to their knowledge for any of these patients. Storage condition at the time of the excursion was refrigerated. Individual vials or unbroken cartons were 2 unbroken cartons 20 vials. Vial was moved from freezer to refrigerator on 07-Sep-2022. Vials were not visualized.  Treatment information was not provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; 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 49-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 22-Sep-2022 at 2:22 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 22-Sep-2022 at 2:22 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.        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 (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant product reported by the reporter. Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022. Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state 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 medication reported by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccines have undergone several temperature excursions and been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and been administered to patient; 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 been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 27-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.     Unknown whether patient ever been diagnosed with/ tested positive for COVID-19.     On 24-Sep-2022 at 3:24 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 3:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and 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 been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medication was reported. 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.  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 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 Aug-2022.  Date vial moved from freezer to refrigerator was 07-Sep-2022.  No adverse reactions reported for the patient.  No treatment information was provided.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: they have received expired doses of FLUZONE HIGH DOSE QIV with no reported adverse event; Initial information received on 03-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves 5 patients of unknown age and gender who received expired doses of fluzone high dose qiv with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (expiry date: 20-JUN-2022), (lot number, strength was unknown) via unknown route in unknown administration site as Immunization with no reported adverse event (expired product administered) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigue/some fatigue after receiving your first SHINGRIX vaccine; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     Additional Information: GSK receipt date: 02-Nov-2022 Reporter's comment:  The case was reported by patient. The patient received the first dose of Shingrix vaccine. The patient asked how long fatigue would last as side effect of the vaccine. The patient experienced some fatigue after receiving the first dose of Shingrix vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Hypersomnia, Pain
Clinical narrative: I just finished my bout with Shingles; blisters; my body was in so much pain; I mostly slept; I only had one shot because they run out of the 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, blister, general body pain, sleep excessive and product availability issue. On an unknown date, the outcome of the shingles, blister, general body pain and sleep excessive were recovered/resolved and the outcome of the product availability issue was unknown.   It was unknown if the reporter considered the shingles, blister, general body pain and sleep excessive to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter mentioned as he/she just finished his/her bout with Shingles.  The blisters were not the worst. The rest of his/her body was in so much pain. The patient mostly slept.  He/she only had one shot because the pharmacy had run out of the second shot. Get the vaccines. Additional supportive information:  Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: MURDERED TOO MANY OF FAMILY AND FRIENDS; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. Reporter stated that, "You have put a sour taste in my mouth for your company after coming out and pushing the "C" shot. You, along with the other company's have murdered too many of my family and friends with the EXPERIMENTAL shots! And to use aborted fetal tissue of ANY amount in the production of this shot is frankly no different than worship to help the community! How dare you push this on people?! Shameful!" On an unspecified date, the patients died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20221116362-murdered too many of family and friends. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Gout, Hypersensitivity
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; ALLERGY; GOUT; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, kidney stones, low testosterone, enlarged prostate, sleep apnea, and statins allergy (patient had muscle weakness when treated with statins.). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old. No concomitant medications were reported.  No adverse event reported post vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 03-MAY-2022 for covid-19 prophylaxis. Patient was revaccinated with different covid-19 vaccine (dose number in series 2). On an unspecified date in 2022, the patient developed gout, and allergy (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the gout, allergy and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221121516.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pulled from the frozen at 9:49 to the fridge,then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT STORAGE ERROR (Pulled from the frozen at 9:49 to the fridge, then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis. 43 tNo Medical History information was reported.    On 07-Nov-2022 at 10:45 AM, 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 STORAGE ERROR (Pulled from the frozen at 9:49 to the fridge,then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Pulled from the frozen at 9:49 to the fridge,then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45) 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 assessment was provided for PRODUCT STORAGE ERROR (Pulled from the frozen at 9:49 to the fridge,then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45).    No concomitant medications was provided. No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2022: Non-significant follow up- Occupation of reporter updated.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; 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 (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Aug-2022 at 11:47 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Sep-2022 at 1:18 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-Aug-2022 at 11:47 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 (Refridgeration excursions identified) 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 (Refridgeration excursions identified) 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 (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.  Patient received the dose 1 and dose 2 of vaccine in 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 state vaccines were housed in these units. The manufactures were notified, and the state 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: F
Vaccine: COVID19
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).    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 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.  No treatment information was provided by the reporter.