Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
She is immuno compromised; Skin totally came off with her left elbow exposing the bones and tendons; Flu like symptoms; Low grade fever; Does start to get breaking out these patches; Almost look like burns in her arms and her legs; Nasty burns; Does start to get breaking out these patches; Almost look like burns in her arms and her legs; Nasty burns; Severe weakness in her left arm; pain associated with the shoulder in the arm; Severe weakness in her left arm; pain associated with the shoulder in the arm; This is a spontaneous report received from an Other HCP. A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertensive" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), administration date: 2024, for Covid-19 Immunization. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "She is immuno compromised"; SKIN EXFOLIATION (medically significant), outcome "unknown", described as "Skin totally came off with her left elbow exposing the bones and tendons"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; SKIN DISORDER (non-serious), SKIN DISCOLOURATION (non-serious), outcome "unknown" and all described as "Does start to get breaking out these patches; Almost look like burns in her arms and her legs; Nasty burns"; MUSCULAR WEAKNESS (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Severe weakness in her left arm; pain associated with the shoulder in the arm". The patient underwent the following laboratory tests and procedures: Body temperature: Low grade. Therapeutic measures were taken as a result of skin exfoliation, muscular weakness, arthralgia. Clinical course: The caller reported for his wife. They had the first two covid vaccines a year and a half ago when it first came out and then they got the two boosters in the springtime six months later which was about a year ago. He was fine but his wife had flu-like symptoms almost immediately that same day and low-grade fever. She did start to get breaking out patches that almost looked like burns on her arms and her legs. They opened up and looked like nasty burns. The big problem was on her left elbow, the skin totally came off with her left elbow exposing the bones and tendons. She had five surgeries on her left elbow to repair it. They placed a skin grip from her left thigh over it and that seems to help the problem. She did talk to her primary care Physician who have heard several numerous adverse reactions of different place of people who had the covid vaccine. The MD was attributing it as well as they were to the booster and her adverse reaction to it because the caller did not have it, but the wife did. She is now immunocompromised; she was not supposed to get any more vaccines. She was supposed to take extremely good care of herself, not to get ill because that could be dangerous for her. The caller clarified that this was after the second booster, after the first two doses. The caller also added that his wife also had severe weakness in her left arm and pain associated with the shoulder in the same arm. She takes over-the-counter medications for that. The caller was a Dentist, and his wife was a Nurse anesthetist. 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: Given the compatible time association, the reasonable possibility that the events are related to BNT162B2 OMI XBB.1.5 administration cannot be completely excluded. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. This case will be reassessed should additional information become available. 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.
Medical History/Concurrent Conditions: Hypertensive
Test Name: Body temperature; Result Unstructured Data: Test Result:Low grade