Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
shakes; n/v (nausea and vomiting); n/v (nausea and vomiting); fever; sudden redness pain of one implant; sudden redness pain of one implant; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in 2025 as dose number unknown, single for immunisation. The patient's relevant medical history included: "Breast CA survivor" (unspecified if ongoing); "implants", start date: Mar2025, stop date: Mar2025, notes: 7 months ago. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2025, 24 hrs after the suspect product(s) administration, outcome "unknown", described as "fever"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 2025, latency 24 hrs after the suspect product(s) administration, outcome "unknown" and all described as "n/v (nausea and vomiting)"; TREMOR (non-serious) with onset 2025, 24 hrs after the suspect product(s) administration, outcome "unknown", described as "shakes"; IMPLANT SITE PAIN (non-serious), IMPLANT SITE ERYTHEMA (non-serious) all with onset 2025, latency 24 hrs after the suspect product(s) administration, outcome "unknown" and all described as "sudden redness pain of one implant". The events "shakes", "n/v (nausea and vomiting)", "fever" and "sudden redness pain of one implant" required physician office visit. Therapeutic measures were taken as a result of tremor, nausea, vomiting, pyrexia, implant site pain, implant site erythema. Additional information: Breast CA survivor- implants 7 months ago. Received covid shot- with flu shot- severe reaction 24 hours later- n/v (nausea and vomiting), shakes, fever. Followed by sudden redness pain of one implant. Followed up with plastic surgeon- on cipro and NSAID, Acetaminophen. The patient asked if there were cases resolving in the research without implant removal. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Breast prosthesis implantation (7 months ago)
Medical History/Concurrent Conditions: Breast cancer