Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Numbness in her forehead; forehead numb; This is a spontaneous report received from a consumer from medical information team, Program ID. A 50-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Little bit fat" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Joint pain". The following information was reported: HYPOAESTHESIA (non-serious) with onset Apr2024, 20 min after the suspect product(s) administration, outcome "recovered" (Apr2024), described as "Numbness in her forehead; forehead numb". Therapeutic measures were not taken as a result of hypoaesthesia. Additional Information: The patient had no other conditions, other products, or investigations. The patient has no significant health conditions other than being a little bit fat. When the patient received her last booster in Apr2024 (to stay current and was going to a group setting), she experienced numbness in her forehead about 20 minutes after she received the vaccine (made her forehead numb), but it went away (recovered completely). It only lasted for less than 5 minutes and went away. No treatment was received for the event. The patient wanted to know if she should be concerned about getting another vaccine booster and if the forehead numbness could be a buildup of too much of the spike proteins. Her pharmacist said not to worry about the forehead numbness as they had heard about this before. The patient doesn't understand how the vaccine works and why there is a new one seemingly every year that patients need to get. The patient would like to know if she can get booster again with her children with the 2024 formulation in Oct2025. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500069247 Same patient and product; different dose and event;
Medical History/Concurrent Conditions: Weight increased