Received Mar 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
allergic type reaction across chest, it was red and itchy; allergic type reaction across chest, it was red and itchy; allergic type reaction across chest, it was red and itchy; This is a spontaneous report received from an Other HCP. A 79-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jan2021, for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Feb2021, when the patient was 76 years old, for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Dec2021, when the patient was 76 years old, for Covid-19 Immunization. The following information was reported: HYPERSENSITIVITY (medically significant), PRURITUS (medically significant), ERYTHEMA (medically significant) all with onset Nov2024, outcome "recovered" and all described as "allergic type reaction across chest, it was red and itchy". The events "allergic type reaction across chest, it was red and itchy" required physician office visit. The patient underwent the following laboratory tests and procedures: Red blood cell sedimentation rate: high. Therapeutic measures were taken as a result of hypersensitivity, pruritus, erythema. Clinical course: It was reported that their mother, the patient, had the Pfizer COVID vaccine, clarified as Comirnaty. Patient was 79 years old when had adverse reaction. Mentioned patient had Pfizer COVID vaccine, confirmed Comirnaty, and said right after had allergic type reaction across chest, it was red and itchy. This was in 2024. Reporter believes age 79 in 2024. Medical conditions reported as patient now has PMR, clarified polymyalgia rheumatica from Feb2025. Had vaccine in Oct or Nov2024, thinks Nov2024, and kept getting sick and sick. Patient had never been sick before like this, has no autoimmune disease, nothing. Lab tests included sed rate was high. Allergic type reaction across chest, it was red and itchy start date reported as Nov2024 and stop date reported as not ongoing but still has PMR. Seriousness was medically significant, but not requiring resuscitation or anything. Comirnaty in Nov2024 and no specific date to provided. Concomitant Product, patient did not received any other vaccines on the same date as the Pfizer vaccine. Patient did not received any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. Adverse event not required visit to the Emergency Room, visited a rheumatologist. Patient not hospitalized. Treatment reported as been on steroids for a few years now, just took antihistamine at the time. Patient medical history included patient had 3 COVID shots prior in Jan2021, Feb2021, and Dec2021. Then patient had flu shot that made her sick with PMR, clarifying and confirming patient just had itchy reaction from Pfizer Comirnaty. It was reported as patient clarified and confirmed that the only reaction patient got from the Pfizer Comirnaty was itchy chest or something and took antihistamine, and then it resolved itself. Since then patient did get a flu shot and from flu shot patient got PMR. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event allergic reaction, itchy, redness and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Test Name: sed rate; Result Unstructured Data: Test Result:high