Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID) in a 41-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and Nirmatrelvir, Ritonavir (Paxlovid) for an unknown indication. The patient's past medical history included COVID-19 in February 2025. Concurrent medical conditions included Postural orthostatic tachycardia syndrome, Hypotension and Marfan's syndrome. On 18-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form and Nirmatrelvir, Ritonavir (Paxlovid) (unknown route) 1 dosage form. In February 2025, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient had suspicion by having all of those boosters and vaccines and prevented contracting COVID before. The patient had COVID one time and suspected that the combination of that and Paxlovid had kept it at bay. No treatment medications were reported. This case was linked to MOD-2025-789303 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2025: Live Non-significant follow-up received: Reference added.
Hypotension; Marfan's syndrome; Postural orthostatic tachycardia syndrome
Medical History/Concurrent Conditions: COVID-19
Paxlovid