Received Jul 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | HG5967 | OT / RA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 379AT | LA |
Soreness in the arm; sore injection site; Soreness in the arm; Like he could not feel anything; bruised; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Lot number: HG5967) at the age of 66 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), as dose number unknown, single (Lot number: 379AT), in left deltoid for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: MOUNJARO taken for diabetes mellitus; TELMISARTAN taken for hypertension. Vaccination history included: Covid-19 vaccine (primary immunization series complete; unknown manufacturer), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Soreness in the arm"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "sore injection site"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Soreness in the arm; Like he could not feel anything"; CONTUSION (non-serious), outcome "unknown", described as "bruised". The events "soreness in the arm", "sore injection site" and "soreness in the arm; like he could not feel anything" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, hypoaesthesia, contusion. Clinical course: The patient received all the doses of the COVID vaccine, like he received all different COVID vaccine and the last vaccine that he received (clarified as Pfizer COVID-19 Vaccine) had the side effect on him. He consulted his family doctor, and they cannot figure out why. The side effect that he is experiencing is soreness in the arm for over a year and half. The side effect is soreness in the arm, like he could not feel anything, and this was from the last vaccine that he received. LOT#: HG5967. Took Tylenol every now and then, but it (soreness in arm) still keeps coming back. It goes away, it may help for a while, but Tylenol wears off and he do not want to keep talking too much Tylenol. He has been experiencing this for over a year and a half, and the side effect would not go away. So, again, they tried to consult the doctor. They did not find anything and his arm could not feel anything. That is how he described it. Got all the different covid vaccine and the last vaccine has residual side effects, and his family doctor can't figure out why. He is wondering why he is having that soreness still in the arm that bruised. The (inaudible) checked the arm and they couldn't feel any knots or anything in the arm. The internal family doctor on his annual checkup did not find anything and can't explain. The patient is just curious on what's going on because it is not a pleasant feeling. Residual side effects (sore injection site) from 31Oct2023 Covid vaccine.
Medical History/Concurrent Conditions: Blood pressure high; Diabetes
MOUNJARO; TELMISARTAN