Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Product administered at inappropriate site, Skin discolouration
Clinical narrative: bad GI gastric feeling; diarrhea/diarrhea movement/bowl moment; had cold; nausea/feel like throw-up; headache; feeling like shut down; hyperventilation; her face was gray/both hands and arms are white/ her face was gray; passed out; Reality perception off; small bowl moment; injected to wrong site; stomach got hungry; her vision was different,; was not able to sleep; Very painful contraction; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and ACUTE PSYCHOSIS (Reality perception off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injected to wrong site), INCREASED APPETITE (stomach got hungry), VISUAL IMPAIRMENT (her vision was different,), INSOMNIA (was not able to sleep) and PAIN (Very painful contraction). On 07-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ACUTE PSYCHOSIS (Reality perception off) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (bad GI gastric feeling), DIARRHOEA (diarrhea/diarrhea movement/bowl moment), FEELING COLD (had cold), NAUSEA (nausea/feel like throw-up), HEADACHE (headache), MALAISE (feeling like shut down), HYPERVENTILATION (hyperventilation), SKIN DISCOLOURATION (her face was gray/both hands and arms are white/ her face was gray) and ABDOMINAL DISCOMFORT (small bowl moment). On 06-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injected to wrong site) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out), INCREASED APPETITE (stomach got hungry), VISUAL IMPAIRMENT (her vision was different,), INSOMNIA (was not able to sleep), DIARRHOEA (diarrhea/diarrhea movement/bowl moment), FEELING COLD (had cold), NAUSEA (nausea/feel like throw-up), HEADACHE (headache), MALAISE (feeling like shut down), HYPERVENTILATION (hyperventilation), SKIN DISCOLOURATION (her face was gray/both hands and arms are white/ her face was gray) and PAIN (Very painful contraction) had not resolved, ACUTE PSYCHOSIS (Reality perception off) and ABDOMINAL DISCOMFORT (small bowl moment) outcome was unknown and GASTROINTESTINAL DISORDER (bad GI gastric feeling) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information include Ibuprofen 200mg initially 1 tablet a day, then every 4 hours in order to get inflammation down.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.