Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
loss of syncope; had the sore arm/arm hurts a lot for several days; not feeling well; had loss of appetite; lack of energy; lethargic; had some disorientation; didn't sleep well Friday night/couldn't sleep all night; could not get out of bed or get up off the couch without her husband helping her; balance issues when getting up; sort of mixed up, mean she was just not herself; currently a little foggy; experienced nausea; felt like was gonna throw up; headache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (loss of syncope) in an elderly female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (loss of syncope) (seriousness criterion medically significant), PAIN IN EXTREMITY (had the sore arm/arm hurts a lot for several days), MALAISE (not feeling well), DECREASED APPETITE (had loss of appetite), ASTHENIA (lack of energy), LETHARGY (lethargic), DISORIENTATION (had some disorientation), INSOMNIA (didn't sleep well Friday night/couldn't sleep all night), MOBILITY DECREASED (could not get out of bed or get up off the couch without her husband helping her), BALANCE DISORDER (balance issues when getting up), CONFUSIONAL STATE (sort of mixed up, mean she was just not herself), BRAIN FOG (currently a little foggy), NAUSEA (experienced nausea), VOMITING (felt like was gonna throw up) and HEADACHE (headache). At the time of the report, SYNCOPE (loss of syncope), PAIN IN EXTREMITY (had the sore arm/arm hurts a lot for several days), MALAISE (not feeling well), DECREASED APPETITE (had loss of appetite), ASTHENIA (lack of energy), LETHARGY (lethargic), DISORIENTATION (had some disorientation), INSOMNIA (didn't sleep well Friday night/couldn't sleep all night), MOBILITY DECREASED (could not get out of bed or get up off the couch without her husband helping her), BALANCE DISORDER (balance issues when getting up), CONFUSIONAL STATE (sort of mixed up, mean she was just not herself), NAUSEA (experienced nausea), VOMITING (felt like was gonna throw up) and HEADACHE (headache) outcome was unknown and BRAIN FOG (currently a little foggy) had not resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that, patient was currently a little foggy. After the shot, she had a sore arm. Patient had got this shot on Friday, and as the day progressed, she started not feeling well. She didn't sleep well on Friday night. The patient fell asleep early but couldn't sleep all night and woke up at 12 and thought that it was the next day and then went back to sleep. On the next day, which was Saturday, she had lack of energy. She stated that she could not get out of bed or get up off the couch without help. She had a loss of syncope, lethargic, and had balance issues when getting up. It was added that her arm hurt a lot for several days and had some disorientation and was not sure what day it was and when it was sort of mixed up, she was just not herself. Patient had a COVID-19 shot every year and noted that her worst symptom was a sore arm. The last booster she had was a month before her trip in March. She did not know the lot number of the vaccine given to her but verified it was the latest vaccine which the pharmacy received on Monday. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789244, US-MODERNATX, INC.-MOD-2025-789242, US-MODERNATX, INC.-MOD-2025-789243 (E2B Linked Report). This case was linked to MOD-2025-789239, MOD-2025-789240 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789243:Patient son case (R-D) US-MODERNATX, INC.-MOD-2025-789244:Patient son case (D-D) US-MODERNATX, INC.-MOD-2025-789242:Patient daughter case (A-D)