Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Flatulence, Gastritis, Illness, Loss of consciousness
Clinical narrative: Passed out; Bruised head; Head bumps; Diarrhea; Dehydration; Hives between fingers; Gastritis really bad/Gastritis after the vaccine; Too sick to get up out of the chair/Sick since having covid in November; Fell once but caught herself; Weak; Could not get up and down; Gas goes up in the head and neck and shoulder; pain from gastritis; Not yet received her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LISINOPRIL and METFORMIN 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 an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), CONTUSION (Bruised head), SKIN LESION (Head bumps), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydration), URTICARIA (Hives between fingers), GASTRITIS (Gastritis really bad/Gastritis after the vaccine), ILLNESS (Too sick to get up out of the chair/Sick since having covid in November), FALL (Fell once but caught herself), ASTHENIA (Weak), MOBILITY DECREASED (Could not get up and down), FLATULENCE (Gas goes up in the head and neck and shoulder), ABDOMINAL PAIN UPPER (pain from gastritis) and PRODUCT DOSE OMISSION ISSUE (Not yet received her 2nd dose). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CONTUSION (Bruised head), SKIN LESION (Head bumps), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydration), URTICARIA (Hives between fingers), GASTRITIS (Gastritis really bad/Gastritis after the vaccine), ILLNESS (Too sick to get up out of the chair/Sick since having covid in November), FALL (Fell once but caught herself), ASTHENIA (Weak), MOBILITY DECREASED (Could not get up and down), FLATULENCE (Gas goes up in the head and neck and shoulder), ABDOMINAL PAIN UPPER (pain from gastritis) and PRODUCT DOSE OMISSION ISSUE (Not yet received her 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided by reporter.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.