Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | — | — |
A few weeks after the booster, had a brain bleed; heart went into SVT (suddenly hit 245); This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE INTRACRANIAL (A few weeks after the booster, had a brain bleed) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Dose 2) and COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine and COVID-19 vaccine. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE INTRACRANIAL (A few weeks after the booster, had a brain bleed) (seriousness criterion medically significant) and SUPRAVENTRICULAR TACHYCARDIA (heart went into SVT (suddenly hit 245)). At the time of the report, HAEMORRHAGE INTRACRANIAL (A few weeks after the booster, had a brain bleed) and SUPRAVENTRICULAR TACHYCARDIA (heart went into SVT (suddenly hit 245)) outcome was unknown. Related DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: suddenly hit 245. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered HAEMORRHAGE INTRACRANIAL (A few weeks after the booster, had a brain bleed) and SUPRAVENTRICULAR TACHYCARDIA (heart went into SVT (suddenly hit 245)) to be related. No concomitant medication was reported. It was unknown if patient had allergies to medications, food, and other products. It was unknown events cause the patient to seek medical care. It was unknown there any other factors that could have led to the adverse events. It was unknown if patient experienced a similar event in the past. It was reported that patient took the first 2 shots and 8 months later the booster. A few weeks after the booster patient had a brain bleed than heart went into SVT (suddenly hit 245). Patient was a very healthy person and patient health issues were directly related to the COVID vaccine. No treatment information was reported. Regulatory Agency ID: DCP-0461-25; Reporter's Comments: Company comment: Concurrent intracranial hemorrhage can provide etiology for supraventricular tachycardia (SVT) hance SVT is assessed as not related. The benefit-risk relationship of product is not affected by this report.
Test Name: heart went into SVT; Result Unstructured Data: suddenly hit 245