Received Feb 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | OT |
autoimmune type of reaction; felt sick; joints hurt; could not regulate her temperature; immune response showing elevated/immune response took months to normalize; Route of administration for BNT162B2: Subcutaneous; LIVE TELEPHONIC VACCINE ASSESSMENT PROGRAM This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 74-year-old female patient received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Route of administration for BNT162B2: Subcutaneous"; AUTOIMMUNE DISORDER (medically significant) with onset 10Dec2021, outcome "unknown", described as "autoimmune type of reaction"; TEMPERATURE REGULATION DISORDER (non-serious) with onset 10Dec2021, outcome "unknown", described as "could not regulate her temperature"; MALAISE (non-serious) with onset 10Dec2021, outcome "unknown", described as "felt sick"; IMMUNE SYSTEM DISORDER (non-serious) with onset 10Dec2021, outcome "unknown", described as "immune response..showing elevated/immune response took months to normalize"; ARTHRALGIA (non-serious) with onset 10Dec2021, outcome "unknown", described as "joints hurt". The events "autoimmune type of reaction", "felt sick", "joints hurt", "could not regulate her temperature" and "immune response..showing elevated/immune response took months to normalize" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: immune response that was showing elevated, notes: every 6 weeks; Immunology test: immune response that was showing elevated, notes: every 6 weeks; Normal, notes: It took months for her immune response to normalize. Additional information: Patient developed autoimmune type of reaction after her COVID19 booster in 2021. She felt sick and her joints hurt for several months, she could not regulate her temperature for several months. Her primary care provider had to do blood work every 6 weeks to monitor her immune response that was showing elevated. It took months for her immune response to normalize. The reporter's assessment of the causal relationship of "autoimmune type of reaction", "felt sick", "joints hurt", "could not regulate her temperature", "immune response..showing elevated/immune response took months to normalize" and "route of administration for bnt162b2: subcutaneous" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162B2 will be requested and submitted if and when received.; Sender's Comments: The events of autoimmune disorder, temperature regulation disorder, malaise, immune system disorder, and arthralgia are considered possibly related, given the close temporal association with vaccination and known potential for immune-mediated and systemic reactions following immunization
Test Name: blood work; Result Unstructured Data: Test Result:immune response that was showing elevated; Comments: every 6 weeks; Test Name: immune response that was showing elevated; Result Unstructured Data: Test Result:immune response that was showing elevated; Comments: every 6 weeks; Test Name: immune response that was showing elevated; Result Unstructured Data: Test Result:Normal; Comments: It took months for her immune response to normalize.