Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
kept passing out; broke my nose; cardiac effect; had COVID/States the fatigue was pretty severe; typical high fever or moderate fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (kept passing out) and CRANIOFACIAL FRACTURE (broke my nose) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Zoledronic acid (Reclast) 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 Zoledronic acid (Reclast) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (kept passing out) (seriousness criterion medically significant), CRANIOFACIAL FRACTURE (broke my nose) (seriousness criterion medically significant), CARDIAC DISORDER (cardiac effect), COVID-19 (had COVID/States the fatigue was pretty severe) and PYREXIA (typical high fever or moderate fever). At the time of the report, LOSS OF CONSCIOUSNESS (kept passing out), CRANIOFACIAL FRACTURE (broke my nose), CARDIAC DISORDER (cardiac effect), COVID-19 (had COVID/States the fatigue was pretty severe) and PYREXIA (typical high fever or moderate fever) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient had lots of health issues but was also healthier than most people in some ways. She worked out all the time and could go further and longer on a treadmill than most people half her age and considered herself fit but had health challenges. It was reported that, the patient had received the Moderna COVID vaccine for the last couple of years. Never had any huge issues with the vaccine at all, she expected to get a fever. It was mentioned that even minor things would put her in the hospital. One time she had COVID, despite an antiviral, despite all the vaccines, she could not work full time for a month. Her fatigue was pretty severe, and she did not end up thankfully with pneumonia or anything which she was prone to but also had her pneumonia shots. It was reported that the only thing she usually got is the typical high fever or moderate fever, etc. It was reported that she had horrible effects, had Reclast and still did not understand it that had a cardiac effect and kept passing out and broke her nose, etc. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Causality for Craniofacial fracture was assessed as not related, due to vaccine´s mechanism of action. The benefit-risk relationship of product is not affected by this report.
RECLAST