Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
achy feeling in the body; soreness of the arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy feeling in the body), PAIN IN EXTREMITY (soreness of the arm) and FATIGUE (tiredness) in an 8-decade-old female 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. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy feeling in the body), PAIN IN EXTREMITY (soreness of the arm) and FATIGUE (tiredness). At the time of the report, PAIN (achy feeling in the body), PAIN IN EXTREMITY (soreness of the arm) and FATIGUE (tiredness) had resolved. No concomitant medication was reported. No medical conditions, no vaccines within the past 4 weeks prior to receiving her last COVID-19 vaccine. The patient probably had at least 2 or 3 shots with Moderna COVID-19 vaccine, but she had more Pfizer COVID-19 shots and received several Moderna COVID-19 shots. But the patient was unsure if it was the Pfizer or the Moderna COVID-19 vaccine she had a year ago. The patient wanted to know if the Spikevax vaccine would alter anything of their laboratory work on Monday as the patient would be receiving the said product on the day of reporting in the afternoon. The patient also asked if the mNEXSPIKE covered the same variant with Spikevax. The patient then followed up by asking if she would have a reaction to the said product if she did not have any major reaction with her previous Moderna COVID-19 vaccine. The patient had soreness of the arm as everybody does, a little achy feeling in the body, tiredness which usually went away after 2 days. The patient did not remember which Moderna COVID-19 vaccine or Pfizer COVID-19 vaccine she had to the said reactions. The patient described these reactions as slight, light and not bad. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact