Received Oct 6, 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 spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER (prostate cancer) in a 62-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and COVID-19 vaccine for an unknown indication. Previously administered products included for Product used for unknown indication: shingrix in 2016 and flu shots (flu shots). Past adverse reactions to the above products included No adverse effect with flu shots and shingrix. Family history included Heart disorder. Concurrent medical conditions included Hypothyroidism. In 2021, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. In 2021, received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of COVID-19 vaccine (unknown route) 1 dosage form. In March 2023, the patient experienced PROSTATE CANCER (prostate cancer) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore arm). The patient was treated with Surgery (had surgery for prostate cancer in September 2024) for Prostate cancer. At the time of the report, PROSTATE CANCER (prostate cancer) outcome was unknown and PAIN IN EXTREMITY (a sore arm) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. It was reported that the patient experienced a sore arm for a day and that was it after an unspecific COVID vaccine. The Patient was received two doses of Pfizer in Fall 2021 and after that the patient received Moderna COVID-19 vaccine every year afterwards. It was reported that the patient should get vaccines as often as he has heart disease in his family history and has personal issues including hypothyroidism. The Patient had surgery for his prostate cancer in Sep- 2024. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789703 (E2B Linked Report).; Reporter's Comments: 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.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789703:Same reporter, different patient
Hypothyroidism
Medical History/Concurrent Conditions: Heart disorder