Received Mar 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
damaged nervous system; pain in his neck and shoulders; pain in his neck and shoulders; ASSESSMENT PROGRAM This is a solicited report received from an Other HCP, Program ID. An 84-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2021 as dose 1, single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (hospitalization, disability) with onset 21Dec2021, outcome "not recovered", ARTHRALGIA (hospitalization, disability) with onset 21Dec2021, outcome "not recovered" and all described as "pain in his neck and shoulders"; NERVOUS SYSTEM DISORDER (hospitalization, disability), outcome "not recovered", described as "damaged nervous system". The events "damaged nervous system" and "pain in his neck and shoulders" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of nervous system disorder, neck pain, arthralgia. Clinical course: Patient received the vaccine from (withheld) in Dec2021. It was his first time receiving the vaccine. Two days later, patient woke up in excruciating pain in his neck and shoulders. He felt like he was being squeezed all over. Patient went to the hospital and they couldn't confirm if the vaccine caused the reaction. The diagnosis ended up being a damaged nervous system, and patient has been on pain medications ever since. It is to be noted that the patient received the COVID vaccine two more times after the incident in May and Oct2022. The reporter's assessment of the causal relationship of "damaged nervous system" and "pain in his neck and shoulders" 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: Based on limited information in the case provided and considering temporal association, there is reasonable possibility of causal association between the events NECK PAIN, ARTHRALGIA, NERVOUS SYSTEM DISORDER and the suspect drug BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.