Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
he experienced a little soreness in the arm; soreness; malaise; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (he experienced a little soreness in the arm), PAIN (soreness), MALAISE (malaise) and PYREXIA (fever) in an 80-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Concurrent medical conditions included Immunosuppression NOS. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and second dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (he experienced a little soreness in the arm), PAIN (soreness), MALAISE (malaise) and PYREXIA (fever). The patient was treated with Acetylsalicylic acid (Aspirin) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (he experienced a little soreness in the arm), PAIN (soreness), MALAISE (malaise) and PYREXIA (fever) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient had less side effects with Moderna (COVID19) vaccine. He said he had both Moderna and Pfizer. With Pfizer, he had the second dose and everything else had been with Moderna. He also mentioned that he had heard on the news that Moderna was more effective than Pfizer in the older population and that he had less side effects with the Moderna vaccination. It was reported that with Moderna COVID19 vaccine, he experienced a little soreness in the arm for 2 days. In terms of the Pfizer vaccine, he stated it had been a while either 2022 or 2023 when he received the vaccine, but he experienced a mild fever, soreness, malaise which aspirin cured after the 2nd day. He was at that age where his immunity was marginal at best and that he continued with wearing a mask in public places. It was unknown if the patient experienced any additional symptoms or events.
Immunosuppression NOS