Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | OT |
soreness; malaise; fever; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-788935 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose 1, single for covid-19 immunisation. The patient's relevant medical history included: "immunosuppression NOS" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "soreness"; MALAISE (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever". Therapeutic measures were taken as a result of pain, malaise, pyrexia. Additional information: This spontaneous case was reported by a consumer and describes the occurrence of pain in extremity (experienced a little soreness in the arm), pain (soreness), malaise (malaise) and pyrexia (fever) in a 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 condition 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 (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 (experienced a little soreness in the arm), pain (soreness), malaise (malaise) and pyrexia (fever) had resolved. No concomitant medication was reported. The patient had less side effects with Moderna (COVID19) vaccine. The patient had both Moderna and Pfizer. With Pfizer, the patient had the second dose and everything else had been with Moderna. Also mentioned that had heard on the news that Moderna was more effective than Pfizer in the older population and that had less side effects with the Moderna vaccination. It was reported that with Moderna COVID19 vaccine, the patient experienced a little soreness in the arm for 2 days. In terms of the Pfizer vaccine, stated it had been a while either 2022 or 2023 when received the vaccine, but experienced a mild fever, soreness, malaise which aspirin cured after the 2nd day. The patient was at that age where immunity was marginal at best and that continued with wearing a mask in public places. It was unknown if the patient experienced any additional symptoms or events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Immunosuppression NOS