Received Aug 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
autoimmune disease; tinnitus/worsened after 2nd shot; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) 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, reaction(s): "Tinnitus". The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus/worsened after 2nd shot". Additional information: The patient developed tinnitus 2 weeks after 1st covid shot. It's worsened after 2nd and 3rd shots. It was also reported that after the 2nd and 3rd vaccine, the patient developed an autoimmune disease. The patient asked if it is safe to get more and asked how to monitor heath after developing autoantibodies The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500158037 same patient/reporter, different vaccine dose/AE;US-PFIZER INC-202500157611 same patient/reporter, different vaccine dose/AE;