Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | ER8732 | OT / LA |
Sometimes I get to sleep, you know, two or three hours at a time; daily intense pruritus head to toe; Intense head to toe pruritus; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER8732, Expiration Date: Jul2021) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Never smoked" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Multivitamin, notes: only took a multivitamin. Vaccination history included: Flu shot (annual/every fall). The following information was reported: INSOMNIA (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Sometimes I get to sleep, you know, two or three hours at a time"; PRURITUS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "daily intense pruritus head to toe; Intense head to toe pruritus". The event "daily intense pruritus head to toe; intense head to toe pruritus" required physician office visit. Therapeutic measures were taken as a result of pruritus. Additional information: The patient had multiple visits to the Physician's office in 2021 and early 2022. GP MDs and RNs prescribed various type of steroids, antihistamines and antibiotics but none resolved the AE. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient was not taking any other medication within 2 weeks prior to the event onset and did not receive any other vaccine within 4 weeks prior to first administration of the suspect product.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381378 Pfizer Inc.;US-PFIZER INC-202200845402 same patient/drug, different dose;
Medical History/Concurrent Conditions: Non-smoker