chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
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 67-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 11:03 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 11:03 AM, 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, 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 information was provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: refrigeration excursions identified; No Adverse Event; vaccines undergone several temperature excursions and was administered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and was administered to the patient) and NO ADVERSE EVENT (No Adverse Event) in a 40-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 4:46 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 4:46 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 (vaccines 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, PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and was administered to the 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) and POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and was administered to the patient).    No concomitant medications were reported.  Vaccination site was 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 reported for the patient.  No treatment medications were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
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 36-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 23-Sep-2022 at 1:34 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 1:34 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, 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 information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: refrigeration excursions identified; No Adverse Event; Vaccine have undergone several temperature excursions and was administered to the patient; 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 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022 at 10:49 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 17-Sep-2022 at 10:49 AM,  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.  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 reported for the patient.  No treatment medications were reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No Adverse Event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) in a 57-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 12:55 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 12:55 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported. Patient received the 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 reported for the patient. No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
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 63-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 18-Sep-2022 at 4:55 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 18-Sep-2022 at 4:55 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, 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 information was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: refrigeration excursions identified; No Adverse Event; Vaccine have undergone several temperature excursions and was administered to the patient; 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 59-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 26-Sep-2022 at 10:44 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022 at 10:44 AM, 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.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.  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 reported for the patient.  No treatment medications were reported.
Age: 2.0
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; Vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) 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.     No Medical History information was reported.    On 27-Aug-2022 at 10:37 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Aug-2022 at 10:37 AM, 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 (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) 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 (Vaccine that underwent temperature excursions could have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions).    No concomitant medication was provided. Patient had received vaccine on deltoid body site. 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. Storage condition at the time of the excursion-Refrigerator. There were 2 unbroken cartons and 20 vials.Two different lot numbers AS1412B and 057A22A were reported. The vial(s) moved from freezer to refrigerator on 7-SEP-2022.  Reportedly, 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. It was reported that no adverse reactions were reported to their knowledge for any patients. It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19. Treatment medication was not provided by the reporter.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccines stored in the refrigerator underwent several temperature excursions; No adverse event; Vaccines stored in the refrigerator underwent several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     The patient had no allergies to medications, food, and other products.     On 21-Sep-2022 at 1:21 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Sep-2022 at 1:21 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions) 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 stored in the refrigerator underwent several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions).    No concomitant medication information was provided.  The patient received the vaccine in the deltoid muscle.  The vaccine was stored in the refrigerator at the time of the excursion. There were 2 unbroken cartons with 20 vials.  The vials of monovalent vaccines were moved from freezer to refrigerator on 07-Sep-2022. All the vials were not visualized.  No adverse reactions reported for the patient as per the reporter's knowledge.  No treatment information was reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No Adverse Event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) in a 41-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 25-Sep-2022 at 5:58 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 5:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.   Dose 4 vaccine administered through deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any of these patients.  The Nurse reports a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   The Nurse was now calling about Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   No information was available on that patients at this time.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient had received moderna vaccine doses 1, 2, and 3 intramuscularly and at the deltoid site of the body.  No treatment medications were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units) and NO ADVERSE EVENT (No adverse event) in a 25-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 5:51 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 22-Sep-2022 at 5:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units).    No concomitant products were reported.  Anatomical location for vaccine administration was reported as deltoid.  It was reported that 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.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. No adverse reactions reported for the patient.  No treatment products were reported.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No Adverse Event; Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units) and NO ADVERSE EVENT (No Adverse Event) in a 9-month-old male 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 3:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 25-Aug-2022 at 3:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units) 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 (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units).    No concomitant products were reported.  Anatomical location for vaccine administration was reported as 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.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. No adverse reactions reported for the patient.  No treatment products were reported.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Patient experienced an allergic reaction to the first dose of the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Patient experienced an allergic reaction to the first dose of the Moderna) 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 first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Patient experienced an allergic reaction to the first dose of the Moderna). At the time of the report, ALLERGY TO VACCINE (Patient experienced an allergic reaction to the first dose of the Moderna) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medicine were reported. No treatment medicine were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in a 53-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 16-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 16-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    Concomitant medication not reported. Treatment medication not reported. Dose 1, dose 2, dose 3 were administered on unknown date by route intramuscular and on deltoid. Dose 4 administered by 3:05 PM with dose 0.5.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: diagnosed with urticaria as a reaction due to histamine release; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (diagnosed with urticaria as a reaction due to histamine release) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had never been diagnosed or tested positive for COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccination.  The patient's past medical history included Mosquito bite (had reactions with mosquito bites since patient was 5 years old). Concurrent medical conditions included Shellfish allergy, Herbal allergy (sage), Spice allergy (sumac) and Allergy to chemicals (preservatives).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced URTICARIA (diagnosed with urticaria as a reaction due to histamine release). At the time of the report, URTICARIA (diagnosed with urticaria as a reaction due to histamine release) outcome was unknown.            No concomitant medication information was reported.  2 to 3 days after getting the vaccine, the patient again had the same skin reaction of red dots on her legs after receiving the second dose of the Moderna COVID-19 vaccine. Patient started getting red dots on her legs again and at this time it was itchy too. She again went to her dermatologist and was diagnosed with urticaria as a reaction due to histamine release.  Patient reported that she had a history of reactions like that with mosquito bites since she was 5 years old.  Patient reported that she iced the rash and put aloe vera on that and she had not had any more rashes since her second dose.   This case was linked to MOD-2022-670154, MOD-2022-669963 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Skin reaction
Clinical narrative: diagnosed with urticaria as a reaction due to histamine release; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (diagnosed with urticaria as a reaction due to histamine release) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had never been diagnosed or tested positive for COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccination.  The patient's past medical history included Mosquito bite (had reactions with mosquito bites since patient was 5 years old). Concurrent medical conditions included Shellfish allergy, Herbal allergy (sage), Spice allergy (sumac) and Allergy to chemicals (preservatives).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced URTICARIA (diagnosed with urticaria as a reaction due to histamine release). At the time of the report, URTICARIA (diagnosed with urticaria as a reaction due to histamine release) outcome was unknown.            No concomitant medication information was reported.  2 to 3 days after getting the vaccine, the patient again had the same skin reaction of red dots on her legs after receiving the second dose of the Moderna COVID-19 vaccine. Patient started getting red dots on her legs again and at this time it was itchy too. She again went to her dermatologist and was diagnosed with urticaria as a reaction due to histamine release.  Patient reported that she had a history of reactions like that with mosquito bites since she was 5 years old.  Patient reported that she iced the rash and put aloe vera on that and she had not had any more rashes since her second dose.   This case was linked to MOD-2022-670154, MOD-2022-669963 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Glaucoma, Headache, Myalgia, Pyrexia
Clinical narrative: I was diagnosed with glaucoma this summer; temperature went up to 98.8F/it's usually 97F; very, very, very mild headache; mild aching; This spontaneous case was reported by a patient and describes the occurrence of GLAUCOMA (I was diagnosed with glaucoma this summer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insect bite allergy (Reaction with Mosquito bite since she was 5 years old), Shellfish allergy, Herbal allergy (Sage allergy), Spice allergy (Sumac allergy) and Allergy to chemicals (Allergic to Preservatives).    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In November 2021, the patient experienced PYREXIA (temperature went up to 98.8F/it's usually 97F), HEADACHE (very, very, very mild headache) and MYALGIA (mild aching). In 2022, the patient experienced GLAUCOMA (I was diagnosed with glaucoma this summer) (seriousness criterion medically significant). At the time of the report, GLAUCOMA (I was diagnosed with glaucoma this summer), PYREXIA (temperature went up to 98.8F/it's usually 97F), HEADACHE (very, very, very mild headache) and MYALGIA (mild aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 98.8 F.         Concomitant medication include eye drops for glaucoma. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID-19 positive test or diagnosis. No treatment medication details was reported.  Company comment- This spontaneous case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected serious (medically significant) event of glaucoma. Three doses of mRNA-1273 vaccine (given as first, second and booster dose) were administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination dates. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-670153, MOD-2022-669963 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected serious (medically significant) event of glaucoma. Three doses of mRNA-1273 vaccine (given as first, second and booster dose) were administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination dates. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Myalgia; Chills; Headache; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 042B21-2A) for COVID-19 prophylaxis.     Previously administered products included for Pain: Ibuprofen (Route-oral and 200 mg). Past adverse reactions to the above products included No adverse event with Ibuprofen. Concurrent medical conditions included Sulfonamide allergy (Sulfa drug allergy), Drug allergy and Acid reflux (oesophageal). Concomitant products included ALGELDRATE, SODIUM ALGINATE (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) for Acid reflux (oesophageal).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2022-668484, MOD-2022-670156 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss after receiving the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss after receiving the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss after receiving the Moderna vaccine). At the time of the report, ALOPECIA (hair loss after receiving the Moderna vaccine) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-670181, US-MODERNATX, INC.-MOD-2022-670192 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670181:Female case 1 US-MODERNATX, INC.-MOD-2022-670192:Female case 2