Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
She has had COVID and got very, very sick from it once before; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She has had COVID and got very, very sick from it once before) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. Concurrent medical conditions included Asthma, Multiple allergies (allergies due to asthma) and Bronchitis (frequent bronchitis). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She has had COVID and got very, very sick from it once before). At the time of the report, COVID-19 (She has had COVID and got very, very sick from it once before) outcome was unknown. Upon internal review on 03-Sep-2025, it was determined that the patient did not experience any adverse event after receiving SPIKEVAX 2024-2025 PFS vaccine as the patient nowhere stated that she got COVID-19 due to the recent vaccination. Therefore, only one case MOD-2025-788981 (US-MODERNATX-MOC20250828000018) with suspect SPIKEVAX NOS will be retained in the database as it was reported that "she had gotten all her shots with Moderna". Hence all information from duplicate case MOD-2025-788965 (US-MODERNATX-MOC20250828000018) was added and merged with the retained case MOD-2025-788981 (US-MODERNATX-MOC20250828000018). The case MOD-2025-788965 (US-MODERNATX-MOC20250828000018) will be deleted from the safety database. It was unclear if patient turned 64 years in July or would turn 64 this August and then it was reported that she was 2 months into her 64th year. No concomitant medication was reported. It was reported that the patient had received her flu shot and COVID-19 shot last fall, and she had received all her shots with Moderna. Patient had COVID and got very, very sick from it once before. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided.
Asthma; Bronchitis (frequent bronchitis); Multiple allergies (allergies due to asthma)