Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
prostate cancer; a sore arm; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789712 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) and in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing). The patient's family history included: "Cardiac disorder" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Shingrix, administration date: 2016, for Immunization, reaction(s): "No adverse event"; Influenza vaccine, for Immunization, reaction(s): "No adverse event". The following information was reported: PROSTATE CANCER (medically significant) with onset Mar2023, outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "a sore arm". Therapeutic measures were taken as a result of prostate cancer. Clinical course: The patient was received two doses of Pfizer in fall 2021 and after that the patient received Moderna COVID-19 vaccine every year afterwards. The patient had surgery for prostate cancer in Sep2024. It was reported that the patient experienced a sore arm for a day and that was it after an unspecific COVID vaccine. It was reported that the patient should get vaccines as often as has heart disease in family history and has personal issues including hypothyroidism. No treatment medications provided by the reporter. Case Comment/Sender Comment: Co-suspect Pfizer vaccine is a confounder for the events. Due to lack of biological plausibility, the causality of the event prostate cancer was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Hypothyroidism
Medical History/Concurrent Conditions: Cardiac disorder