Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
allergic to this LP.8.1. protein; throat tightened; it was scary/it was pretty frightening; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 2025, outcome "unknown", described as "allergic to this LP.8.1. protein"; FEAR (non-serious) with onset 2025, outcome "unknown", described as "it was scary/it was pretty frightening"; THROAT TIGHTNESS (non-serious) with onset 2025, outcome "unknown", described as "throat tightened". Additional information: The patient received the new Pfizer COVID vaccine (2025-2026) a month ago and she just wanted to confirm what the difference between the new and the previous formulation is. The patient mentioned that apparently she was allergic to this LP.8.1. protein. She has had a number of COVID shots but this was the first time she had a severe reaction after vaccination. The patient stated she had a reaction to the new covid shot, her throat tightened. She did not go to the hospital, but it was scary. So, for her to get more shots next year, she wanted to know what is different, what ingredients was different with the new covid shot, so that she can check before she gets it again because it was pretty frightening. She never had the reaction before and she has had five to six covid shots over the years starting with the epidemic of covid and she never had that reaction. She wanted to know what is the new ingredient, so that she can make sure that it does not happen again. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.