chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
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 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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 23-Sep-2022 at 3:12 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 3:12 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, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (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: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refrigeration excursions identified/undergone several temperature excursions; 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 (Refrigeration excursions identified/undergone several temperature excursions), 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 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1746B) for COVID-19 prophylaxis.     It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.     On 25-Sep-2022 at 4:41 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 4:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/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 (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 (Refrigeration excursions identified/undergone several temperature excursions) 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, vaccine was housed in the units. There were excursions noted. Manufactures were notified and the department was made aware of the situation.  No adverse reactions were reported for any of the patients at the time of the report. No treatment medication reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported. Treatment information was not provided.  Company Comment: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced a fatal and medically Significant serious unexpected event of Myocardial Infarction 2 days after receiving a dose of mRNA-1273.222 vaccine. The details of previous doses were not provided. The cause of death was reported as died of natural causes. There was no information provided about the patient's age, underlying medical conditions, concomitant medications, clinical course of the event, associated symptoms, final diagnosis, diagnostic and treatment details. It is not known if an autopsy was performed. The benefit-risk relationship of mRNA-1273.222 vaccine, is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced a fatal and medically Significant serious unexpected event of Myocardial Infarction 2 days after receiving a dose of mRNA-1273.222 vaccine. The details of previous doses were not provided. The cause of death was reported as died of natural causes. There was no information provided about the patient's age, underlying medical conditions, concomitant medications, clinical course of the event, associated symptoms, final diagnosis, diagnostic and treatment details. It is not known if an autopsy was performed. The benefit-risk relationship of mRNA-1273.222 vaccine, is not affected by this report.; Reported Cause(s) of Death: Died of natural causes
Age: 33.0
Sex: F
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 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 33-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 22-Sep-2022 at 1:28 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022 at 1:28 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).    Concomitant product use was not provided by the reporter.  Dose 4 anatomical site was reported as deltoid.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022.  Refrigeration excursions were identified, vaccine was housed in the units. There were excursions noted. Manufactures were notified and was made aware of the situation.  No adverse reactions were reported for patient at the time of the report.  Treatment information was not provided.
Age: 58.0
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 may have been administered to patients; 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 (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 58-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 12:31 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 12:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    Patient received vaccine in deltoid. No concomitant product reported by the reporter.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions experienced by the patient. It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  No treatment medication reported by the reporter.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (The Moderna monovalent and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 53-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 5:56 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 5:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The Moderna monovalent and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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 (The Moderna monovalent and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (The Moderna monovalent and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).
Age: 51.0
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 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 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022 at 11:21 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 24-Sep-2022 at 11:21 AM, 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: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 47-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.              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 / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient).    Concomitant Medication use information was not provided by reporter.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.     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 (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient).    No concomitant product use was reported.  It was unknown whether the patient was diagnosed/tested positive for COVID-19.  The vaccination site was reported as deltoid.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Vaccination site lymphadenopathy
Clinical narrative: Sore arm; swelling of the lymph nodes in right arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in right arm) 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. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Nov-2022, 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 PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in right arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in right arm) outcome was unknown.     No concomitant drug was reported. Patient received bivalent vaccine as second booster dose. No treatment drug was reported.   Reporter did not allow further contact
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid/Had 3 positive tests; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for Covid/Had 3 positive tests) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 027C21A, 030L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy, Sulfonamide allergy and Penicillin allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced COVID-19 (Tested positive for Covid/Had 3 positive tests). At the time of the report, COVID-19 (Tested positive for Covid/Had 3 positive tests) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2022, SARS-CoV-2 test: Positive. In October 2022, SARS-CoV-2 test: Positive and Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient had 3 positive covid-19 test until the 22-Oct-2022. No treatment medication were provided.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthma, Diarrhoea, Dizziness, Dyspnoea, Fall
Clinical narrative: shortness of breath; felt very bad / feeling like passing out or falling; thought it was asthmatic Bronchitis; can not do any functions but sit around; eyes were itchy; feeling like passing out or falling; diarrhea; dizziness; chest broke out in hives; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), FEELING ABNORMAL (felt very bad / feeling like passing out or falling), ASTHMA (thought it was asthmatic Bronchitis), MOBILITY DECREASED (can not do any functions but sit around) and PRURITUS (eyes were itchy) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010h22a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine (6 weeks earlier flu shoot). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Vegetable allergy and Contrast media allergy.    On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced DYSPNOEA (shortness of breath), FEELING ABNORMAL (felt very bad / feeling like passing out or falling), ASTHMA (thought it was asthmatic Bronchitis), MOBILITY DECREASED (can not do any functions but sit around), PRURITUS (eyes were itchy), FALL (feeling like passing out or falling), DIARRHOEA (diarrhea), DIZZINESS (dizziness) and URTICARIA (chest broke out in hives). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath) had not resolved, FEELING ABNORMAL (felt very bad / feeling like passing out or falling), ASTHMA (thought it was asthmatic Bronchitis), MOBILITY DECREASED (can not do any functions but sit around), PRURITUS (eyes were itchy), FALL (feeling like passing out or falling) and DIARRHOEA (diarrhea) outcome was unknown and DIZZINESS (dizziness) and URTICARIA (chest broke out in hives) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: oxygen 95 to 97.         Patient was on regular prescribed meds. On 04-Feb-2021 patient received dose 1 with lot 004m22a. On 11-Mar-2021 patient received dose 2 with lot 038a21a. On 01-Nov-2021 patient received dose 3 with 071f21a. On 25-Jul-2022 patient received dose 4  with lot 055a22a.Patient was scared. The patient had never been diagnosed with/ tested positive for COVID-19. Patient called his allergist twice. Patient used inhaler to control his asthma instead of 2 puffs he was using 2 puffs 3 times a day.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Mobility decreased, Oxygen saturation, Pruritus, Urticaria
Clinical narrative: shortness of breath; felt very bad / feeling like passing out or falling; thought it was asthmatic Bronchitis; can not do any functions but sit around; eyes were itchy; feeling like passing out or falling; diarrhea; dizziness; chest broke out in hives; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), FEELING ABNORMAL (felt very bad / feeling like passing out or falling), ASTHMA (thought it was asthmatic Bronchitis), MOBILITY DECREASED (can not do any functions but sit around) and PRURITUS (eyes were itchy) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010h22a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine (6 weeks earlier flu shoot). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Vegetable allergy and Contrast media allergy.    On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced DYSPNOEA (shortness of breath), FEELING ABNORMAL (felt very bad / feeling like passing out or falling), ASTHMA (thought it was asthmatic Bronchitis), MOBILITY DECREASED (can not do any functions but sit around), PRURITUS (eyes were itchy), FALL (feeling like passing out or falling), DIARRHOEA (diarrhea), DIZZINESS (dizziness) and URTICARIA (chest broke out in hives). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath) had not resolved, FEELING ABNORMAL (felt very bad / feeling like passing out or falling), ASTHMA (thought it was asthmatic Bronchitis), MOBILITY DECREASED (can not do any functions but sit around), PRURITUS (eyes were itchy), FALL (feeling like passing out or falling) and DIARRHOEA (diarrhea) outcome was unknown and DIZZINESS (dizziness) and URTICARIA (chest broke out in hives) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: oxygen 95 to 97.         Patient was on regular prescribed meds. On 04-Feb-2021 patient received dose 1 with lot 004m22a. On 11-Mar-2021 patient received dose 2 with lot 038a21a. On 01-Nov-2021 patient received dose 3 with 071f21a. On 25-Jul-2022 patient received dose 4  with lot 055a22a.Patient was scared. The patient had never been diagnosed with/ tested positive for COVID-19. Patient called his allergist twice. Patient used inhaler to control his asthma instead of 2 puffs he was using 2 puffs 3 times a day.
Age: 82.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022) and NO ADVERSE EVENT (No adverse event) in an 82-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022) 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 EXPIRED PRODUCT ADMINISTERED (One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022).    No concomitant drug was reported. The vial was initially stored in the refrigerator on 11-Oct-2022. Size of vial was reported as 2.5 ml. It was reported that vial did not undergo any temperature excursions. No treatment drug was reported.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Joint swelling, Rash macular, SARS-CoV-2 test, Urticaria
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of JOINT SWELLING (both ankles are swollen intermittently), URTICARIA (non-itchy welt on the right wrist) and RASH MACULAR (a non-itchy, big area on left calf which was red and blotchy/my right hip has non-itchy blotches on it,) 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. 057F22A) for COVID-19 vaccination.     The patient's past medical history included Von Willebrand's disease (A bleeding disorder diagnosed 26 years ago, which has since healed.), Platelet dysfunction (Platelet function defect in the secretion part of the blood.) in 2015 and COVID-19 in 2020. Previously administered products included for Drug use for unknown indication: Influenza in September 2022. Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Drug allergy (Epinephrine), Soap allergy (Zest Soap), Drug allergy (Ibuprofen), Oil allergy (Fish oil), Ankles swollen (intermittently which started 2 years ago.), Alopecia (diagnosed 4 yrs ago.), Osteoporosis, Dry eye (Chronic Blepharitis Rosacea) and Vitamin D deficiency.   On 02-Nov-2022 at 5:15 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced RASH MACULAR (a non-itchy, big area on left calf which was red and blotchy/my right hip has non-itchy blotches on it,). On 10-Nov-2022, the patient experienced JOINT SWELLING (both ankles are swollen intermittently). On an unknown date, the patient experienced URTICARIA (non-itchy welt on the right wrist). At the time of the report, JOINT SWELLING (both ankles are swollen intermittently), URTICARIA (non-itchy welt on the right wrist) and RASH MACULAR (a non-itchy, big area on left calf which was red and blotchy/my right hip has non-itchy blotches on it,) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: Positive.         No treatment medications was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Stiffness in right thumb; sore arm with covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in right thumb) and VACCINATION SITE PAIN (sore arm with covid-19 vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in right thumb) and VACCINATION SITE PAIN (sore arm with covid-19 vaccine). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in right thumb) and VACCINATION SITE PAIN (sore arm with covid-19 vaccine) outcome was unknown.            Relevant concomitant medications were not reported. On unknown date, the patient experienced sore arm with COVID-19 vaccine, Stiffness in right thumb. Treatment information was not provided.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the event(s) of Stiffness in right thumb and sore arm with covid-19 vaccine with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Stiffness in right thumb and sore arm with covid-19 vaccine with Moderna COVID-19 vaccine (Elasomeran) was Not Provided. AbbVie's opinion was that the causality for the event(s) of Stiffness in right thumb and sore arm with covid-19 vaccine with Adalimumab Solution for Injection was Not Provided. AbbVie's opinion was that the causality for the event(s) of Stiffness in right thumb and sore arm with covid-19 vaccine with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; supposed to get their first dose of the Moderna series and instead got a Bivalent booster; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (supposed to get their first dose of the Moderna series and instead got a Bivalent booster), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 10-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (supposed to get their first dose of the Moderna series and instead got a Bivalent booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (supposed to get their first dose of the Moderna series and instead got a Bivalent booster), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (supposed to get their first dose of the Moderna series and instead got a Bivalent booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    No Concomitant medications were provided. It was reported that clinic Administrator had a person who was supposed to get first dose of the Moderna series and instead got a Bivalent booster. No treatment medications were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: patient experienced some bad reactions; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (patient experienced some bad reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (patient experienced some bad reactions). At the time of the report, IMMUNISATION REACTION (patient experienced some bad reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose, Decreased appetite, Nausea
Clinical narrative: loss of appetite; nauseous; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (loss of appetite) and NAUSEA (nauseous) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 immunisation.     Patient had no allergies.  Previously administered products included for Drug use for unknown indication: flu vaccine (past month). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Hypertension and Type 1 diabetes mellitus. Concomitant products included LOSARTAN for Hypertension, INSULIN for Type 1 diabetes mellitus.   On 09-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced DECREASED APPETITE (loss of appetite) and NAUSEA (nauseous). At the time of the report, DECREASED APPETITE (loss of appetite) and NAUSEA (nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2022, Blood glucose: high.   Concomitant medications also included insulin pump. On 01 Feb 2021 patient received first dose of Moderna vaccine with lot number 030L20A. On 01 Mar 2021 patient received second dose of Moderna vaccine with lot number 001A21A. On 27 Oct 2021 patient received first booster dose of Moderna vaccine with lot number 025D21A. It was reported that patient had the second booster dose of the Moderna vaccine and was reporting that she was nauseous, has loss of appetite and high blood sugars. Adverse event did not cause patient to seek medical care  Patient did not experienced a similar event in the past. The symptoms were ongoing. No treatment medications were provided.   This case was linked to MOD-2022-670554 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered more than 12 hours post the initial vial puncture; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered more than 12 hours post the initial vial puncture) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered more than 12 hours post the initial vial puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered more than 12 hours post the initial vial puncture) 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 EXPIRED PRODUCT ADMINISTERED (Administered more than 12 hours post the initial vial puncture).    No concomitant medications were reported.  It was reported that a dose was administered form a vial that had been previously punctured. The HCP was not sure when the initial puncture time or date was and was concerned that it may had been administered  more than 12 hours post the initial vial puncture.  No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 001A21A and 030L20A) for COVID-19 vaccination.     Patient had no allergies.  Previously administered products included for Product used for unknown indication: Flu vaccine (past month). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Hypertension and Type I diabetes mellitus. Concomitant products included LOSARTAN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at a dose of for 5 days. At the time of the report, COVID-19 (Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medications also included insulin pump.   This case was linked to MOD-2022-670551 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid after 2 doses of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid after 2 doses of Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid after 2 doses of Moderna). At the time of the report, COVID-19 (Covid after 2 doses of Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter and the patient wanted to know how long should the patient wait before receiving the booster dose after experiencing COVID.  No treatment medications were reported.   Reporter did not allow further contact