Received Sep 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
he has some numbness and severe pain in his feet/it can be neuropathy; he has some numbness and severe pain in his feet/it can be neuropathy; he has some numbness and severe pain in his feet/his arm would be sore for about a day/it can be neuropathy; After having his COVID shot he mentioned having difficulty getting off of the toilet because his arm would be sore for about a day; he has a lesion on his kidney; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-020715 (BioNTech), 2025SA246640 (Sanofi). A 68-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; sarilumab (KEVZARA), at 200 mg (200 mg, every other week), subcutaneous for polymyalgia rheumatica. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid shots (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid shots (DOSE 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "recovering", HYPOAESTHESIA (non-serious), outcome "not recovered" and all described as "he has some numbness and severe pain in his feet/it can be neuropathy"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "he has some numbness and severe pain in his feet/his arm would be sore for about a day/it can be neuropathy"; MOBILITY DECREASED (non-serious), outcome "recovering", described as "After having his COVID shot he mentioned having difficulty getting off of the toilet because his arm would be sore for about a day"; RENAL DISORDER (non-serious), outcome "recovering", described as "he has a lesion on his kidney". On an unknown date, the patient reported he has some numbness (unknown latency) and severe pain in his feet (unknown latency). After he takes his injection, he feels better. He has an appointment with new MD (doctor of medicine) on 26Aug2025 as his previous provider passed away. He believes its neuropathy (unknown latency). He currently has three doses on hand. He advised that he now takes his injection every 3 to 4 weeks to make it stretch (unknown latency). Patient reported after the last three doses are taken will try wing himself off. He was uncertain if Kevzara really works (unknown latency). He believes this started when he started taking the COVID shots. After having his COVID shot, he mentioned having difficulty getting off of the toilet because his arm would be sore for about a day (unknown latency). He also stated that he has a lesion on his kidney (unknown latency) that the doctor told him that it was nothing to lose sleep over. The action taken for sarilumab was unknown. At time of reporting, the outcome was not recovered/not resolved for event hypoaesthesia, recovering/resolving for event pain in extremity and unknown for the remaining events. Batch/lot number is not provided, and it cannot be obtained. BNT162b2 omicron (kp.2) is under agreement with BIONTECH SE.
KEVZARA