Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
complete hell as her ears have swelled up 3 times the size; couldn't hear; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR SWELLING (non-serious), outcome "unknown", described as "complete hell as her ears have swelled up 3 times the size"; HYPOACUSIS (non-serious), outcome "unknown", described as "couldn't hear". Additional Information: Caller stated that she took Comirnaty last November and had "used Moderna all of the way through, and she will ever again use a Pfizer product. She has been through complete hell as her ears have swelled up 3 times the size, she couldn't hear, and she was home alone. It was the perfect storm. This is what happenings to human beings, had she known it had a horrific rash, because that's hard to find and you can't really find out anything, it's just a little thing that says you might get hives or rash, it doesn't say how long it's going to last." Caller stated that she is on the 8th day and is asking how much longer will the rash last?. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.