Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
second dose of Comirnaty 23/24; itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg, outside of legs, confirmed both legs, but especially right leg; This is a spontaneous report received from a Consumer or other non HCP. An 81-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Mar2024 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (ongoing), notes: Has had ulcerative colitis for 32 years, is in remission for the past 2 to 3 years.; "Blood pressure" (ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for blood pressure abnormal, stop date: Dec2024. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot: EN5318), administration date: 29Jan2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 26Feb2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 01Oct2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: FM9992), administration date: 17May2022, when the patient was 78-year-old, for Covid-19 immunization; comirnaty bivalente ba.4/ba.5 (DOSE 5 (BOOSTER), SINGLE; lot number: GJ2524), administration date: 09Sep2022, when the patient was 79-year-old, for Covid-19 immunization; comirnaty bivalente ba.4/ba.5 (DOSE 6 (BOOSTER), SINGLE; (Pfizer Bivalent)), administration date: 20May2023, when the patient was 79-year-old, for Covid-19 immunization; comirnaty (2023-2024 formula) (DOSE 7 (BOOSTER), SINGLE; Lot number: HG4629 (Pfizer Comirnaty 23/24)), administration date: 22Sep2023, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Jul2024, outcome "not recovered", described as "itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg, outside of legs, confirmed both legs, but especially right leg"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "second dose of Comirnaty 23/24". Additional information: Calling about the Pfizer COVID vaccination. Caller has had a total of 9 shots of the Pfizer COVID vaccination starting 29Jan2021 and the last one was 06Sep2024. Got it every time became available, because of age was encouraged to take the shot. Has had experience of hives. Cannot prove, not sure, was the COVID vaccination, but the 8th shot was the Comirnaty. The first were Bivalent, thinks all of them up to the 6th shot, and then first Comirnaty was 22Sep2023, which was caller's 7th shot, that was the first Comirnaty caller had. 8th shot was also Comirnaty, well it was 22Mar2024 for the 8th shot. Had no symptoms, none of the shots gave caller any symptoms. Caller's theory, why calling about this, is that sometime in July2024 started itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg, outside of legs, confirmed both legs, but especially right leg. Was scratching, scratching in July, but continued, didn't go away. Was not drawing blood at that time from scratching. Didn't think of it, didn't connect to COVID shot in caller's head. COVID vaccination included When getting these, they write so fast, not real legible, confirmed referring to the handwriting on vaccination card. Confirmed all 9 doses were the Pfizer COVID vaccination. 1st dose on 29Jan2021; NDC, lot, expiry: Only thing written down on card was EN5318; Dose, route: Unknown. 2nd dose on 26Feb2021; NDC, lot, expiry: Cannot even read handwriting under HCP, clinic area, says (redacted) Dose, route: Unknown. 3rd dose on 01Oct2021; NDC, lot, expiry: 30135, can't read it, thinks looks like BA. Got it at Pharmacy Store no.xxxx. Dose, route: Unknown. 4th dose on 17May2022; NDC, lot, expiry: FM9992, that's what it looks like. Got it at Pharmacy Store no. xxxx. Dose, route: Unknown. 5th dose on 09Sep2022; NDC, lot, expiry: GJ2524. Got it at Pharmacy Store no. xxxx. Dose, route: Unknown. 6th dose: Pfizer Bivalent on 20May2023; NDC, lot, expiry: Can't hardly read the handwriting, thinks 676F96. Could be 6 or G for first letter. Dose, route: Unknown. 7th dose (Pfizer Comirnaty 23/24) on 22Sep2023; NDC, lot, expiry: H, 6 or G, 4629, thinks H6, looks like the 6 in 4629; Dose, route: Unknown. 8th dose (Pfizer), so probably the same as above, Pfizer Comirnaty 23/24. Got it at Pharmacy Store no. xxxx on 22Mar2024; NDC, lot, expiry: Unknown, nothing on vaccination card. Dose, route: Unknown. Indication reported Caller was watching TV and caller's daughter is a nurse, and caller's daughter told caller to go get the COVID. Concomitant products included been on low dose blood pressure medication, clarified was on Lisinopril, but switched to a different one, clarified switched to amlodipine, because caller's daughter did research and said sometimes Lisinopril is a problem medication. Confirmed caller is currently on amlodipine. Lisinopril: Therapy dates: Unknown when started, doesn't remember, probably 3 or 4 years ago. Stopped in Dec2024 because switched to Amlodipine. Formulation, dose, route, frequency: 10mg tablet, one tablet a day, by mouth for Blood pressure. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Blood pressure abnormal; Ulcerative colitis (Has had ulcerative colitis for 32 years, is in remission for the past 2 to 3 years.)
LISINOPRIL