Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
Bleeding at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) in a 41-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for Pain. Concurrent medical conditions included Hypertension. On 16-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 16-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at injection site). On 16-Sep-2025, VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) had resolved. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The concomitant medication was not reported by the reporter. The patient had bleeding at the injection site, which resolved within seconds after the injection. The patient did not experience pain. The patient did not have any additional medical history, concomitant disease or risk factor. There was no lab data or results available. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.
Hypertension