Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Eye irritation, Eye pain, Fatigue, Injection site swelling
Clinical narrative: both eyes were burning; both eyes were burning, hurting so bad; hurting so bad, looks like black eyes from a punch; like red flash on both eyes/eyes sensitive to light; hair feels different,does not know why or maybe it was her sense of touch; had a hard knot; swollen injection site, had a hard knot; stomach was all torn up right after the shot was given; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE RUPTURE (stomach was all torn up right after the shot was given) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (specially during summers.). Concomitant products included PROCATEROL HYDROCHLORIDE (PRO-AIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCLE RUPTURE (stomach was all torn up right after the shot was given) (seriousness criterion medically significant) and FATIGUE (exhausted). On 15-Apr-2021, the patient experienced EYE IRRITATION (both eyes were burning), EYE PAIN (both eyes were burning, hurting so bad), CONTUSION (hurting so bad, looks like black eyes from a punch), PHOTOPHOBIA (like red flash on both eyes/eyes sensitive to light), PARAESTHESIA (hair feels different,does not know why or maybe it was her sense of touch), VACCINATION SITE INDURATION (had a hard knot) and INJECTION SITE SWELLING (swollen injection site, had a hard knot). At the time of the report, MUSCLE RUPTURE (stomach was all torn up right after the shot was given), EYE IRRITATION (both eyes were burning), EYE PAIN (both eyes were burning, hurting so bad), CONTUSION (hurting so bad, looks like black eyes from a punch), PHOTOPHOBIA (like red flash on both eyes/eyes sensitive to light), PARAESTHESIA (hair feels different,does not know why or maybe it was her sense of touch), FATIGUE (exhausted), VACCINATION SITE INDURATION (had a hard knot) and INJECTION SITE SWELLING (swollen injection site, had a hard knot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products also include cunasal. Treatment medication were not reported/unknown.  Company Comment : Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded. Fatigue , injection site induration and  injection site swelling are consistent with product known safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded. Fatigue , injection site induration and  injection site swelling are consistent with product known safety profile.