Received Feb 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
pain and suffering; has the COVID virus for 3 times; Moderna sold a product that doesn't work; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (pain and suffering), COVID-19 (has the COVID virus for 3 times) and VACCINATION FAILURE (Moderna sold a product that doesn't work) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain and suffering), COVID-19 (has the COVID virus for 3 times) and VACCINATION FAILURE (Moderna sold a product that doesn't work). At the time of the report, PAIN (pain and suffering), COVID-19 (has the COVID virus for 3 times) and VACCINATION FAILURE (Moderna sold a product that doesn't work) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient had the COVID virus for 3 times since having the Moderna vaccine. She experienced pain and suffering. Moderna sold a product that doesn't work. Investigation Summary & Conclusion with Root Cause Details: On 19FEB2025, a consumer contacted Moderna regarding concerns about the effectiveness of the Spikevax (COVID-19 Vaccine, mRNA). The caller reported that his wife had contracted COVID-19 three times despite receiving the Moderna vaccine, questioning its efficacy. The individual alleged that the vaccine was not properly tested and claimed that it did not prevent COVID-19 as expected. However, no specific product details, such as batch numbers or administration history, were provided, and the caller declined consent for follow-up. The case was forwarded to the Drug Safety team for adverse event reporting, and the regulatory product disclosure was provided. Given that no batch information or additional details were made available, further investigation into the perceived lack of effectiveness was not feasible. It is important to note that while Spikevax is indicated for the prevention of COVID-19, breakthrough infections can still occur due to various factors, including individual immune response and circulating virus variants. No treatment medication was reported. Reporter causality was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2025: Live non-significant information received: reference number added. On 21-Feb-2025: Live significant information received: Closed PQC report received, QC comment and narrative updated.