Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
COVID-19 (COVID/had a borderline severe COVID-19); COVID-19 (COVID/had a borderline severe COVID-19); This is a spontaneous report received from a Physician. Other Case identifier(s): MOD-2025-789307 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine mrna omicron (jn.1) moderna (SPIKEVAX 2024-2025 FORMULA [COVID-19 VACCINE MRNA OMICRON (JN.1) MODERNA]), as 1 df, single for covid-19 prophylaxis. The patient's relevant medical history included: "Postural orthostatic tachycardia syndrome" (ongoing); "Hypotension" (ongoing); "Marfan's syndrome" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2025, outcome "unknown" and all described as "COVID-19 (COVID/had a borderline severe COVID-19)". Clinical course: In Feb2025, the patient experienced COVID-19 (COVID/had a borderline severe COVID-19). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. 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. The patient had a borderline severe case of COVID-19 and had to take Paxlovid (22 days, but no hospitalization was required) 14 weeks after receiving the Spikevax 2024-2025 vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded.
Hypotension; Marfan's syndrome; Postural orthostatic tachycardia syndrome