Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
Have not contracted COVID-19 since, except for once a couple of years ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Have not contracted COVID-19 since, except for once a couple of years ago) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Have not contracted COVID-19 since, except for once a couple of years ago). At the time of the report, COVID-19 (Have not contracted COVID-19 since, except for once a couple of years ago) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient's age was reported as over 70 years old. Between the patient and her husband, one of them had COPD, and the other had a heart condition and had a heart attack (no further clarification was provided). The patient was interested in receiving a second COVID-19 shot in April 2026 and mentioned two vaccines: mNEXSPIKE and Spikevax. She received the Moderna vaccine previously, which she believed worked effectively and expressed gratitude for the vaccine's effectiveness. The patient expressed interest in mNEXSPIKE because she believed it might result in fewer side effects, such as a sore arm for 3 days, compared to other options. As per reporter, there were more side effects with less coverage in protection. The reporter could not fathom that and asked why Spikevax would be recommended for a patient. As per reporter mNEXSPIKE was more effective, it provided more coverage for protection with less side effects. Investigation Summary and Conclusion with Root Cause Details: On 20-Apr-2026, a consumer inquired about mNexSpike vs Spikevax. A potential lack of effect was mentioned after receiving previous Moderna COVID-19 vaccination, mentioning they contracted COVID 19 post-vaccination once a couple years ago. There was no consent for follow up. As outlined in the Information for Recipients and Caregivers acknowledges vaccination with Spikevax might not protect all people who received the vaccine. The incident was forwarded to the Drug Safety team and determined to not be a safety issue. Due to the absence of specific lot numbers, no lot trending could be conducted, and no further investigation was recommended at this time. No treatment medication was reported. Information received on 20-Apr-2026 and 22-Apr-2026 had been processed together in the same case cycle. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2026: Significant live follow-up received which contains PQC closed investigation report: Reporter's contact number was added, suspect details (QC result date and QC comment) were added, narrative was updated, and reference numbers were added.