Received Apr 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | IM |
Angioedema; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concomitant products included Progesterone and Testosterone for an unknown indication. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) outcome was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. This report involved an adverse event notification regarding Spikevax, forwarded in compliance with the guideline for postmarketing reporting of adverse drug experiences. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Initial information and follow-up 1 received on 25-Mar-2026 has been processed together in the same case cycle. Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2026: Live non-significant follow-up received: references added. On 15-Apr-2026: Significant follow up received: Case was updated from invalid to valid, suspect dose number, route of administration and action taken updated, concomitant drugs added, event coding, seriousness updated, narrative updated and references added.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Progesterone; Testosterone