Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | UNK | — | — |
COVID-19; flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice; flu like symptoms/achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/achy), COVID-19 (COVID-19) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/achy) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms/achy) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) had resolved and COVID-19 (COVID-19) outcome was unknown. No concomitant medication was reported. Patient received one dose of MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) in spring 2023. It was reported that patient always had side effects for 36 hours after each one, he had flu-like symptoms, achy, a severe headache described as kind of a crushing headache that headache kind of feel was felt like his head was in a vice. That would last for like 36 hours and once he hit the 36-hour mark, it was just like somebody flipped the switch, disappeared. No treatment information was provided. This case was linked to MOD-2025-789717 (Patient Link).