Received May 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | LA |
can hardly walk/not been able to walk anymore; has pain in his legs; it has a lot of connection with leg cramp and spasm; Patient also took some "Licodine" for back and legs, but it did not work after he got sick; Patient also took some "Licodine" for back and legs, but it did not work after he got sick; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 63-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for immunisation. The patient's relevant medical history included: "Seizures" (ongoing). Concomitant medication(s) included: LEVETIRACETAM taken for seizure (ongoing). Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 immunization. The following information was reported: GAIT INABILITY (medically significant), outcome "not recovered", described as "can hardly walk/not been able to walk anymore"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "has pain in his legs"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "it has a lot of connection with leg cramp and spasm"; BACK DISORDER (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "Patient also took some "Licodine" for back and legs, but it did not work after he got sick". The events "can hardly walk/not been able to walk anymore", "has pain in his legs", "it has a lot of connection with leg cramp and spasm" and "patient also took some "licodine" for back and legs, but it did not work after he got sick" required physician office visit. Therapeutic measures were taken as a result of gait inability, pain in extremity, muscle spasms, back disorder, illness. Clinical course: Patient called after he was administered the RSV flu shot and Pfizer's covid-19 vaccine concomitantly. He went to the pharmacy, and they told him that it was safe to receive both vaccines at the same time. He mentioned that he received the vaccines at the same time, the same arm in the same minute. Additionally, he said that he went online to report it at the (withheld) website. This would be the fourth time getting the shot of Covid but after the last administration he's not been able to walk anymore, before he used to walk 16-18 miles a day. Wants to know if this is a known AE, because it's not normal. He's already went to his PCP, Neurologist and told him that he's fine. Additionally, he was prescribed medications which made his problem worse. Mentioned that from his work he was obliged to get the vaccines. Patient can hardly walk, has pain in his legs, it has a lot of connection with leg cramp and spasm and in an unnecessary painful situation. Other treatment included Voltaren which did not do any good. Patient also took some "Licodine" for back and legs, but it did not work after he got sick. The patient further stated, "Yes, of course, I need to walk. It is impossible for a healthy man which is the suggested by my neurologist and my doctor, my everything. I got like 4 different doctors even my psychologist said nothing wrong with you. Then, overnight my life changed because of this shot, it got to be something wrong and as far as I read, it has a lot of connection with leg cramp and spasm." The information on the batch/lot number for BNT162b2 omicron (kp.2), rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Seizures
LEVETIRACETAM