Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | 33036BD | OT / LA |
MRI results revealing transverse sinus stenosis; transverse sinus stenosis with the transverse thrombosis/Thrombotic events; lot left sided weakness; Unilateral tinnitus; Dizziness; Intolerance; stability balance issues; unilateral headaches; This is a spontaneous report received from a Physician from medical information team, Program ID. A 29-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2022 at 17:45 as dose 3 (booster), 0.3 ml single (Lot number: 33036BD, Expiration Date: 30Jun2022) at the age of 29 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset Jan2022, outcome "unknown"; DRUG INTOLERANCE (non-serious) with onset Jan2022, outcome "unknown", described as "Intolerance"; INTRACRANIAL VENOUS SINUS STENOSIS (medically significant) with onset Jan2022, outcome "unknown", described as "MRI results revealing transverse sinus stenosis"; TINNITUS (non-serious) with onset Jan2022, outcome "not recovered", described as "Unilateral tinnitus"; HEMIPARESIS (medically significant) with onset Jan2022, outcome "unknown", described as "lot left sided weakness"; BALANCE DISORDER (non-serious) with onset Jan2022, outcome "unknown", described as "stability balance issues"; TRANSVERSE SINUS THROMBOSIS (medically significant) with onset Jan2022, outcome "unknown", described as "transverse sinus stenosis with the transverse thrombosis/Thrombotic events"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "unilateral headaches". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Magnetic resonance imaging: transverse sinus stenosis. Clinical course: Caller is a dentist writing a clinical case study about his experience following administration of the Pfizer COVID-19 vaccine in 19Jan2022. He states that he experienced multiple adverse events and would like information regarding the ingredients and formulation of the 2022 COVID-19 vaccine including the amount of vaccine so he may formally describe this information in his case presentation. In particular, caller alleges a possible defect with lot 33036BD booster dose with expiration date of 30Jun2022 stating that it was from the back of the shelf. He states that based on reports he has read, there are some other adverse events associated with certain lots. Caller lists the following which have persisted since 2022 and experienced right after receiving the dose: MRI results revealing transverse sinus stenosis, thrombotic events, unilateral tinnitus, dizziness, intolerance. Regarding the adverse events consumer stated, "One of them was transverse sinus stenosis with the transverse thrombosis. Transverse sinus stenosis and thrombosis of the left dural venous sinus in the oppositional area. This is called unilateral tinnitus, stability balance issues, unilateral headaches and lot left sided weakness, but the main thing is the tinnitus, continuous ringing in the left side, pretty much all day and night from last three years." Concomitant products, other medical conditions and lab work: Consumer stated, "No, blood work within two weeks. Consistence and persistence and 20Jan2022, present in three years. I do not think it is some underlying condition or blood work. I think, it was this product and in my professional medical opinion confirmed by MRI doctor". Treatment: Consumer stated, "For transverse sinus stenosis, I want you to put a 'stenosis' no I did not get anything done. I did not want to get an offered and procedure done no. I did not get anything done, but they wanted to take a further CT scan, and I did not do that either. I do not think, it is good practice from how far that had in that area, is too much radiation in my opinion. So, no treatment for yet and it might get worst you know."; Sender's Comments: As there is limited information in the case provided, the causal association between the events intracranial venous sinus stenosis, transverse sinus thrombosis, and hemiparesis; and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.
Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:transverse sinus stenosis