Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Postural orthostatic tachycardia syndrome
Clinical narrative: postural orthostatic tachycardia syndrome; This spontaneous case was reported by a patient and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome) in a 65-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 vaccination.     The patient did not have any allergy. The patient did not perform COVOD-19 tests or diagnosis. The patient did not have any medical history relating to mentioned AE and both acute and chronic illness at the time of vaccination.  Concomitant products included DIAZEPAM, DIAZEPAM (VALIUM), CLONIDINE and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 12-Sep-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 17-Sep-2022, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome). At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: when he was sit his pulse was 60 and when he stand up his pulse raises to 90.     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.   Patient had previous doses of Moderna covid-19 vaccine -1st dose on 29-Jan-2021 (route intramuscular), 2nd dose on 26-Feb-2021 (route unknown), 1st booster dose on 10-Aug-2021 (route unknown) and 2nd booster on 20-Jan-2022 (route unknown). Patient did not experienced any AEs after previous dose, but 5 or 6 days after getting the bivalent booster, patient developed adverse event.  Lot number and expiration date reported as unknown for suspect product.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient did not experience any similar event in the past. The symptoms severity was same.   No treatment has been given for this symptom, but patient mentioned he would go to visit a cardiologist soon.  Company comment- This is a spontaneous case concerning a 65-year-old male patient treated with quetiapine for an unknown indication, who experienced the unexpected and non-serious AESI postural orthostatic tachycardia syndrome within 5 to 6 days after a dose of mRNA-1273.222 vaccine, given as a third booster dose of COVID-vaccine schedule, was administered. It was reported that patient did not experience any adverse events after previous doses, but 5 or 6 days after getting the bivalent booster patient developed postural orthostatic tachycardia syndrome. When he was sitting his pulse was 60, but when he stood up his pulse raised to 90. No treatment has been given for this symptom, but patient mentioned he would go to visit a cardiologist soon. Concomitant treatment with quetiapine remains as a confounder. The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 65-year-old male patient treated with quetiapine for an unknown indication, who experienced the unexpected and non-serious AESI postural orthostatic tachycardia syndrome within 5 to 6 days after a dose of mRNA-1273.222 vaccine, given as a third booster dose of COVID-vaccine schedule, was administered. It was reported that patient did not experience any adverse events after previous doses, but 5 or 6 days after getting the bivalent booster patient developed postural orthostatic tachycardia syndrome. When he was sitting his pulse was 60, but when he stood up his pulse raised to 90. No treatment has been given for this symptom, but patient mentioned he would go to visit a cardiologist soon. Concomitant treatment with quetiapine remains as a confounder. The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report.