Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood pressure measurement, Blood test, Electrocardiogram, Heart rate
Clinical narrative: fainted this time/feeling lightheaded/razing heartbeat/ heart started to raze agai/nauseas; blood pressure going up/180 over 120 blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted this time/feeling lightheaded/razing heartbeat/ heart started to raze agai/nauseas) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose 4 21 2021 lot #040b21a) on 21-Apr-2021, Moderna COVID-19 Vaccine (2nd-027c21a) on 19-May-2021, Moderna COVID-19 Vaccine (1st booster lot #939903) on 22-Nov-2021 and Moderna COVID-19 Vaccine (2nd booster 4 lot #005m21a) on 28-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Blood pressure high (since 7 years ago).    On 12-Sep-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 23-Sep-2022, the patient experienced SYNCOPE (fainted this time/feeling lightheaded/razing heartbeat/ heart started to raze agai/nauseas) (seriousness criterion medically significant) and HYPERTENSION (blood pressure going up/180 over 120 blood pressure). At the time of the report, SYNCOPE (fainted this time/feeling lightheaded/razing heartbeat/ heart started to raze agai/nauseas) and HYPERTENSION (blood pressure going up/180 over 120 blood pressure) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: blood works, EKG, MRI, MRA, checked balance, fluid in the ear, heart monitor for 2 days & for 30 days, had an episode on the 21st heart started to raze again, echocardiogram ALL NEGATIVE, all results came back normal. On an unknown date, Blood pressure measurement: blood pressure going up/180 over 120 blood pressure. On an unknown date, Blood test: had blood work EKG all negative back to her MD and cardiologist 180 over 120 blood pressure which never happened before // blood works, EKG, MRI, MRA, checked balance, fluid in the ear, heart monitor for 2 days & for 30 days, had an episode on the 21st heart started to raze again, echocardiogram ALL NEGATIVE, all results came back normal. On an unknown date, Electrocardiogram: EKG, MRI, MRA, checked balance, fluid in the ear, heart monitor for 2 days & for 30 days, had an episode on the 21st heart started to raze again, echocardiogram ALL NEGATIVE, all results came back normal and Negative. On an unknown date, Heart rate: razing heartbeat/ heart started to raze again. On an unknown date, Magnetic resonance imaging: blood works, EKG, MRI, MRA, checked balance, fluid in the ear, heart monitor for 2 days & for 30 days, had an episode on the 21st heart started to raze again, echocardiogram ALL NEGATIVE, all results came back normal.     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 medication information was provided. No treatment medications were provided  The patient was wondering of the side effects of the Moderna bivalent. She received the booster in Sep 12 2022, did not have any reaction 24hours after, on Sep 23 razing heartbeat feeling lightheaded and nauseas and blood pressure going up she did not faint this time. She went up in the ER, run multiple tests and they came up negative refer to a cardiologist. On the 7th Dec 2022 at night all of the symptoms started to happen again and fainted this time, went to the ER.  Company comment: This spontaneous case concerns a 66-years-old female patient, with past medical history of Blood pressure high (for 7 years ago), (medically significant) who experienced the unexpected serious events of Syncope and Hypertension that occurred 12 days after the fifth dose of mRNA-1273 bivalent BA.4/BA.5 vaccination.  Patient had received 1st dose, 2nd dose ,1st booster and 2nd booster with mRNA1273 vaccine were received in accordance with recommended schedule. The investigation of Magnetic resonance imaging, blood works, EKG, MRI, MRA, checked balance, fluid in the ear, heart monitor for 2 days & for 30 days, all were negative and within the normal limits. No further information on detailed clinical course, concomitant medications and treatment of the events was available in the report. Outcome of the events were not resolved. The past medical history of Blood pressure high remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine bivalent BA.4/BA.5 is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 66-years-old female patient, with past medical history of Blood pressure high (for 7 years ago), (medically significant) who experienced the unexpected serious events of Syncope and Hypertension that occurred 12 days after the fifth dose of mRNA-1273 bivalent BA.4/BA.5 vaccination.  Patient had received 1st dose, 2nd dose ,1st booster and 2nd booster with mRNA1273 vaccine were received in accordance with recommended schedule. The investigation of Magnetic resonance imaging, blood works, EKG, MRI, MRA, checked balance, fluid in the ear, heart monitor for 2 days & for 30 days, all were negative and within the normal limits. No further information on detailed clinical course, concomitant medications and treatment of the events was available in the report. Outcome of the events were not resolved. The past medical history of Blood pressure high remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine bivalent BA.4/BA.5 is not affected by this report. Event seriousness assessed as per medical judgement.