Received Feb 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | OT |
mast cell inflammation after Covid. He showed spots on his hands, arms, back and belly/ Cutaneous mastocytosis (permanent and progressive skin lesions); The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 20Jan2026, this case now contains all required information to be considered valid. This is a spontaneous report and received from Physicians from a sales representative. A 59-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: MASTOCYTOSIS (disability) with onset Jan2021, outcome "not recovered", described as "mast cell inflammation after Covid. He showed spots on his hands, arms, back and belly/ Cutaneous mastocytosis (permanent and progressive skin lesions)". Clinical course: a urologist reported the patient had mast cell inflammation after receiving a COVID booster. The patient had spots on his hands. The vaccine dosage was reported as the "standard dose." The cutaneous mastocytosis resulted in disability or permanent damage (disfiguring skin disease - permanent and progressive). The patient received anti-histamines, ultraviolet (UV) light therapy, omalizumab (XOLAIR) at 5.0 g a month, cromoglicate sodium (CROMOLYN) orally. Therapeutic measures were taken as a result of mastocytosis. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event "mast cell inflammation after receiving a COVID booster" with BNT162b2, can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None