Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at injection site) in a 70-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. No Medical History information was reported. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (tenderness at injection site). At the time of the report, VACCINATION SITE PAIN (tenderness at injection site) had resolved. No concomitant medications were reported. The patient had COVID vaccinations since they first started coming out, and probably the patient had the most recent one or something within the past year (1 year and a half or something like that). The patient had received last dose last year (2024) or two years ago (2023). The patient did not have any reactions to any of the vaccinations of any kind, particularly in relation to flu vaccines and the COVID vaccines that the patient been getting fairly frequently. Patient had tenderness at the injection site in some cases and for few times, the patient did not have any reaction. Treatment medication was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live follow up Significant information received included patient age updated