Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Syncope
Clinical narrative: feeling a little under the weather; little bit of body ache after each vaccine but not really bad; faint 14 to 16 hours later after dose 1, 2 and Bivalent; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (faint 14 to 16 hours later after dose 1, 2 and Bivalent) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Sep-2022. Previously administered products included for COVID-19 vaccination: Moderna COVID-19 Vaccine (first dose, Lot#011J20A, experienced events fatigue, nausea and vomiting, body ache and faint) on 06-Jan-2021, Moderna COVID-19 Vaccine (second dose, Lot#036L20A, experienced events fatigue, nausea, faint, little bit of body ache) on 03-Feb-2021, Moderna COVID-19 Vaccine (1st booster, Lot#045J2VA, experienced events little bit of body ache and caught Covid-19) on 09-Dec-2021. Past adverse reactions to the above products included Adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 19-Sep-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. In September 2022, the patient experienced SYNCOPE (faint 14 to 16 hours later after dose 1, 2 and Bivalent) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (feeling a little under the weather) and PAIN (little bit of body ache after each vaccine but not really bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SYNCOPE (faint 14 to 16 hours later after dose 1, 2 and Bivalent), MALAISE (feeling a little under the weather) and PAIN (little bit of body ache after each vaccine but not really bad) outcome was unknown.            Patient reported that they fainted 14-16 hours after receiving the bivalent dose. the patient was tested negative for Covid on 31-Aug-2022 before the colonoscopy.  Company comment: This spontaneous case concerns a 71 year old female with no relevant medical history reported, who experienced the serious (medically significant) expected adverse event Syncope , which occurred 14-16 hours after a dose of mRNA-1273  Bivalent .222 (Original/Omicron BA.4/5) vaccine administration given as the fourth dose. The outcome was reported as unknown. Diagnostic workup or treatment medications were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-659972, MOD-2022-659974, MOD-2022-659976 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71 year old female with no relevant medical history reported, who experienced the serious (medically significant) expected adverse event Syncope , which occurred 14-16 hours after a dose of mRNA-1273  Bivalent .222 (Original/Omicron BA.4/5) vaccine administration given as the fourth dose. The outcome was reported as unknown. Diagnostic workup or treatment medications were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.