Received Jan 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
heavy menstrual episode; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (heavy menstrual episode) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (heavy menstrual episode). At the time of the report, HEAVY MENSTRUAL BLEEDING (heavy menstrual episode) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had experienced a short-term adverse reaction following a Moderna COVID-19 vaccination in 2021, which included a heavy menstrual episode that resulted in a precautionary visit to A&E. It was stated that investigations conducted at the time identified no underlying pathology, no follow-up treatment was required, and the symptoms resolved. The reporter further advised that, several years later, patient applied and continued to rely on a long-term exclusion for gynecological conditions. According to the reporter, the patient cited the 2021 vaccine-related episode as evidence of an ongoing or underlying condition. The reporter indicated that the practical effect of this position was that the short-term post-vaccination reaction was being treated as evidence of a long-term medical risk. The reporter requested clarification of Moderna's position regarding this issue. In particular, the reporter sought clarification as to whether Moderna considered short-term adverse effects following COVID-19 vaccination, including transient menstrual changes, to indicate or support an assumption of long-term or chronic underlying conditions. The reporter also requested information on whether Moderna was aware of any evidence supporting the use of transient vaccine-related side effects as a basis for long-term medical exclusions or risk assumptions, and whether short-term post-vaccination menstrual effects were generally regarded as self-limiting and non-predictive of long-term gynecological disease. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2026: Live follow-up received contains non-significant information includes reference ID added.