chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: In October 2021 not long after my booster shot, I was out on a walk and noticed I had a 'squiggle' that went across my vision.  I realized it was blood.  I visited the ophthalmologist and confirmed I had a vitreous detachment in my right eye.  I now just have floaters.  After dose 4, in June 2022, I noticed I was dizzy, and my blood pressure was high.  I was traveling.  In February 2023, while in another country, I was having spiking blood pressure episodes.  I was dizzy with urges to go to the bathroom.  I went to the emergency department.  I also had a grinding sensation in my abdomen with chills.  This happened again after I returned home.  I went to the emergency department again.  No one could explain this reaction in my abdomen.  On another day it happened, and it was also shortness of breath and chest pain.  I saw the doctor next day.  I was told I just may have hypertension.  I am now on a blood pressure medication.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Hypertension, Metamorphopsia, Vitreous detachment, Vitreous floaters
Clinical narrative: In October 2021 not long after my booster shot, I was out on a walk and noticed I had a 'squiggle' that went across my vision.  I realized it was blood.  I visited the ophthalmologist and confirmed I had a vitreous detachment in my right eye.  I now just have floaters.  After dose 4, in June 2022, I noticed I was dizzy, and my blood pressure was high.  I was traveling.  In February 2023, while in another country, I was having spiking blood pressure episodes.  I was dizzy with urges to go to the bathroom.  I went to the emergency department.  I also had a grinding sensation in my abdomen with chills.  This happened again after I returned home.  I went to the emergency department again.  No one could explain this reaction in my abdomen.  On another day it happened, and it was also shortness of breath and chest pain.  I saw the doctor next day.  I was told I just may have hypertension.  I am now on a blood pressure medication.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: pt received moderna bivalent vaccines on 6/6/23 and 7/11/23 (10mcg, pink cap) for primary series.  should have received higher dose of moderna bivalent vaccine (25mcg, blue cap) for both doses instead.  no symptoms reported.  error noted on 7/18/23 after chart review.   I called moderna for guidance, and was directed to call . Recommended pt receive a doses of the moderna bivalent vaccine (25mcg, blue cap) since lower than recommended bivalent dose previously received. no minimum time interval required for the first dose. family notified.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023) 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 (Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023).    Concomitant medication was not reported. It was unknown that the patient had ever been diagnosed with/ tested positive for COVID-19. It was reported that there were no adverse events following the administration of the vaccine. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728617 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728617:Master case (Patient 1 3 years old)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: pharmacist administer vaccine to 9 patients. It looks like the lots are expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pharmacist administer vaccine to 9 patients. It looks like the lots are expired) 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 (pharmacist administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pharmacist administer vaccine to 9 patients. It looks like the lots are expired) 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 (pharmacist administer vaccine to 9 patients. It looks like the lots are expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 2nd out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: pharmacyst administer vaccine to 9 patients. It looks like the lots are expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired) 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 (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired) 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 (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were provided. It was reported that there were no specific dates when administration occurred, but they had the lot number, and it was before 13-Jul-2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.  Dosage text for suspect product was reported as unknown. No treatment medication was provided.  This case contains information about patient 3rd out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacist gave vaccine to 9 patients which looks like the lots were expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) 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 (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) 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 (Pharmacist gave vaccine to 9 patients which looks like the lots were expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 3 out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: pharmacyst administer vaccine to 9 patients. It looks like the lots are expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) 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 (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired) 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 (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and additional Lot numbers were 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 6th out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: pharmacist administer vaccine to 9 patients. It looks like the lots are expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pharmacist administer vaccine to 9 patients. It looks like the lots are expired) 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 (pharmacist administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pharmacist administer vaccine to 9 patients. It looks like the lots are expired) 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 (pharmacist administer vaccine to 9 patients. It looks like the lots are expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 7th out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacist gave vaccine to 9 patients which looks like the lots were expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) 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 (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) 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 (Pharmacist gave vaccine to 9 patients which looks like the lots were expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 8 out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: pharmacist administerd vaccine to 9 patients. It looks like the lots were expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pharmacist administerd vaccine to 9 patients. It looks like the lots were expired) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) 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 (pharmacist administerd vaccine to 9 patients. It looks like the lots were expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pharmacist administerd vaccine to 9 patients. It looks like the lots were expired) 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 (pharmacist administerd vaccine to 9 patients. It looks like the lots were expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and additional Lot numbers were 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 9th out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I had a very mild stroke 4 hrs. after shot; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a very mild stroke 4 hrs. after shot) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (I had a very mild stroke 4 hrs. after shot) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (I had a very mild stroke 4 hrs. after shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient experienced a very mild stroke 4 hrs. after the shot. He lost the use of his right arm and leg. The use of his right arm returned in about a day but leg took about 5 days to be normal again.  Treatment information was not reported.  Company comment:  This spontaneous case concerns a 71  year  old male patient, with no medical history reported, who received a dose with mRNA  1273 original vaccine (reported as fourth dose of his COVID  19 immunization schedule) and experienced the unexpected, serious (medically significant and hospitalization) AESI of cerebrovascular accident. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report mentioned the patient lost the use of his right arm and leg, without facial dropping or speech change. The use of his arm returned in about a day, and the leg took about 5 days to be normal again. The outcome of the event was recovered. No further clinical details were provided for medical reviewing. Patient´s age remains as confounder for the event. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired dose).    No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown that if patient had any relevant medical history, allergy, concomitant diseases and risk factor and was also unknown if patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In October 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 an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that patient had received 5 COVID-19 shots . No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacist gave vaccine to 9 patients which looks like the lots were expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) 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 (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) 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 (Pharmacist gave vaccine to 9 patients which looks like the lots were expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 1 out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734396, US-MODERNATX, INC.-MOD-2023-734397, US-MODERNATX, INC.-MOD-2023-734405, US-MODERNATX, INC.-MOD-2023-734410, US-MODERNATX, INC.-MOD-2023-734413, US-MODERNATX, INC.-MOD-2023-734416, US-MODERNATX, INC.-MOD-2023-734425 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734416:Patient 8 US-MODERNATX, INC.-MOD-2023-734410:Patient  5 US-MODERNATX, INC.-MOD-2023-734405:Patient 4 US-MODERNATX, INC.-MOD-2023-734413:Patient 7 US-MODERNATX, INC.-MOD-2023-734425:Patient 9 US-MODERNATX, INC.-MOD-2023-734397:Patient 3 US-MODERNATX, INC.-MOD-2023-734396:Patient 2
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Stroke (2 strokes).    On 17-Feb-2022, 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 17-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022).    Patient was on blood thinners. He received 6 of the Moderna vaccines and took only one bivalent booster dose on 17-FEB-2022. He was advised that he can't take paxlovid per doctor's recommendation. Treatment information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2023: Follow up received and had no significant information.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Cancer staging and Atrial fibrillation.    On 17-Feb-2022, 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 17-Feb-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022).    Patient had cancer in the past and atrial fib and was taking Blood thinners(ANTICOAGULANT III) Patient had 6 vaccines, but only one bivalent booster dose. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734458 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734458:Husband case
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023; no adverse event; Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023) 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. AS7644C) for COVID-19 prophylaxis.     It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 25-Jul-2023, 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 25-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023) 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 EXPIRED PRODUCT ADMINISTERED (Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023).    No concomitant medication was reported. It was reported that dose administered after 30-day Use By Date or after Manufacturer Date of Expiry. The vial size was reported as 2.5 ml. The vial did not undergo any temperature excursions.  No treatment medication was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 26Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2023 at 12:00 as dose 4 (booster), single (Lot number: 004M21A), in left arm and on 14Jun2023 at 11:00 as dose 5 (booster), single (Lot number: AS71843), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diffuse large B cell lymphoma" (unspecified if ongoing), notes: On 01Aug, I will be 6 mos post R-CHOP chemotherapy for diffuse large B cell lymphoma.; "R-CHOP chemotherapy" (unspecified if ongoing), notes: for diffuse large B cell lymphoma. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2023 at 12:00, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. with Paxlovid from 12Jul2023 to 16Jul2023.  Based on investigation result conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FE3592; EP7534 and EN6204 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FE3592, fill lot FF2553 and the bulk formulated drug product lot FA9141. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. The final scope included the reported finished goods lot EN6204, fill lot EN5335, and the formulated drug product lot EN5325. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257325 same patient, different drug and event;
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 01, 02, 03: Pfizer/ Dose 04: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EX5730) at the age of 45 years, on 15Jan2021 as dose 2, single (Lot number: EL3249) at the age of 45 years, and on 14Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 46 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Sep2022 as dose 4 (booster), single (Lot number: AS7148B) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "not recovered", described as "Dose 01, 02, 03: Pfizer/ Dose 04: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment was given with Paxlovid from 12Jul2023 till 17/Jul/2023, Acetaminophen on 13/Jul/2023, Ibuprofen from 10Jul2023 till 12/Jul/2023.
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery occlusion, Myocardial infarction
Clinical narrative: two arteries clogged/two blocked arteries; heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neutropenia" (unspecified if ongoing), notes: prior to receiving the vaccines; in which her "immune system is shot.". The patient's medical history, reported also as family history included: "heart attack" (unspecified if ongoing), notes: cardiac family history. The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2022, outcome "unknown", described as "heart attack"; CORONARY ARTERY OCCLUSION (medically significant), outcome "unknown", described as "two arteries clogged/two blocked arteries". Therapeutic measures were taken as a result of coronary artery occlusion. Clinical course: Patient asked if it is the estrogen within the Estring that contradicts patients who have a history of heart attacks. Patient wanted to know if she could use Estring if she had a heart attack. She is asking if she should use Estring if she has had a heart attack in the past. She stated that her cardiologist told her estrogen can cause blood clots, but her other HCP is insisting that estrogen doesn't cause blood clots. She has had 5 Pfizer Covid-19 vaccines (presentations were not specified) and her doctor is advising her to receive a 6th vaccine. She is asking if she should receive a 6th vaccine. She feels like she is receiving a vaccine every 6 months. She confirmed that she had neutropenia prior to receiving the vaccines, however she did have a heart attack last year after she received the Pfizer Covid-19 vaccines. She had stents placed due to two arteries clogged. She has a family history of this and does not believe the vaccines were the cause of her heart attack. She doesn't believe the heart attack was related to the COVID-19 Vaccines. She had stents placed because she had two blocked arteries. She has a cardiac family history.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events MYOCARDIAL INFARCTION and The suspected drug is assessed as Unrelated .
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal distension, Arthralgia, Dizziness, Headache, Injection site pain
Clinical narrative: large, intensely itchy. injection site; painful swelling of the injection site; painful swelling of the injection site; headache; nausea; dizziness; significant joint pain.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Jul2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left deltoid for immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "latex" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; PROMETRIUM [PROGESTERONE]; ESTRADIOL. Past drug history included: Clindamycin, reaction(s): "Drug Allergy: Clindamycin"; Ampicillin, reaction(s): "Drug Allergy: ampicillin". The following information was reported: DIZZINESS (non-serious) with onset 16Jul2023, outcome "recovered"; HEADACHE (non-serious) with onset 16Jul2023, outcome "recovered"; NAUSEA (non-serious) with onset 16Jul2023, outcome "recovered"; ARTHRALGIA (non-serious) with onset 16Jul2023, outcome "recovered", described as "significant joint pain."; VACCINATION SITE PRURITUS (non-serious) with onset 19Jul2023, outcome "recovered", described as "large, intensely itchy. injection site"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 19Jul2023, outcome "recovered" and all described as "painful swelling of the injection site". Therapeutic measures were not taken as a result of headache, nausea, dizziness, arthralgia, vaccination site pruritus, vaccination site pain, vaccination site swelling. Additional information: No other vaccine used in same date or in four weeks.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Nausea, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: large, intensely itchy. injection site; painful swelling of the injection site; painful swelling of the injection site; headache; nausea; dizziness; significant joint pain.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Jul2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left deltoid for immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "latex" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; PROMETRIUM [PROGESTERONE]; ESTRADIOL. Past drug history included: Clindamycin, reaction(s): "Drug Allergy: Clindamycin"; Ampicillin, reaction(s): "Drug Allergy: ampicillin". The following information was reported: DIZZINESS (non-serious) with onset 16Jul2023, outcome "recovered"; HEADACHE (non-serious) with onset 16Jul2023, outcome "recovered"; NAUSEA (non-serious) with onset 16Jul2023, outcome "recovered"; ARTHRALGIA (non-serious) with onset 16Jul2023, outcome "recovered", described as "significant joint pain."; VACCINATION SITE PRURITUS (non-serious) with onset 19Jul2023, outcome "recovered", described as "large, intensely itchy. injection site"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 19Jul2023, outcome "recovered" and all described as "painful swelling of the injection site". Therapeutic measures were not taken as a result of headache, nausea, dizziness, arthralgia, vaccination site pruritus, vaccination site pain, vaccination site swelling. Additional information: No other vaccine used in same date or in four weeks.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.