Received Dec 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
pulmonary nodules/progressive increase in lung nodules; pulmonary nodules/progressive increase in lung nodules; limiting head movement; severe body aches and pain; TARGETED IMMUNIZATION ENGAGEMENT (TIE) This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Oct2024 at 16:25 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 15May2022, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "pulmonary nodules", "severe body aches and pain", "limiting head movement"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 19Oct2022, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "pulmonary nodules after each vaccination/CT scans showing a progressive increase in lung nodules", "severe body aches and pain", "limiting head movement"; Moderna (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Nodules". The following information was reported: JOINT RANGE OF MOTION DECREASED (disability) with onset 01Nov2024, outcome "unknown", described as "limiting head movement"; PULMONARY MASS (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 01Nov2024, outcome "unknown" and all described as "pulmonary nodules/progressive increase in lung nodules"; PAIN (non-serious) with onset 01Nov2024, outcome "unknown", described as "severe body aches and pain". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (2024) progressive increase in lung nodules. Clinical course: The patient reported severe body aches and pain following each COVID vaccination, with symptoms limiting head movement and resulting in bed confinement. She also reports developing pulmonary nodules after each vaccination, with CT scans showing a progressive increase in lung nodules. Nodules were first noted after the Moderna vaccine and increased further after switching to Pfizer. The reporter's assessment of the causal relationship of "pulmonary nodules/progressive increase in lung nodules", "limiting head movement" and "severe body aches and pain" with the suspect product(s) BNT162b2 omicron (kp.2) 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 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: The events pulmonary mass, condition aggravated, joint range of motion decreased, and pain are conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The strongest risk factors appear to be advanced age, prior similar reactions, and possible pre-existing pulmonary pathology. 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.,Linked Report(s) : US-PFIZER INC-202500248102 same patient/product/events; different dose;US-PFIZER INC-202500248103 same patient/product/events; different dose;
Test Date: 2024; Test Name: CT scans; Result Unstructured Data: Test Result:progressive increase in lung nodules