Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Frequent bowel movements, Head injury, Loss of consciousness
Clinical narrative: Passed out; head hit the hardwood floor when passed out; loose bowel/keep treating me for diarrhea; still have problem / going to the bathroom 2-4 times/day; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and HEAD INJURY (head hit the hardwood floor when passed out) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013m200 and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other Medical History information was reported.  Concomitant products included CARVEDILOL, TAMSULOSIN, FINASTERIDE and RIVAROXABAN (XARELTO) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced HEAD INJURY (head hit the hardwood floor when passed out) (seriousness criterion hospitalization) and FREQUENT BOWEL MOVEMENTS (still have problem / going to the bathroom 2-4 times/day). On 21-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant). 21-Feb-2021, the patient experienced DIARRHOEA (loose bowel/keep treating me for diarrhea). The patient was hospitalized on 21-Feb-2021 due to LOSS OF CONSCIOUSNESS. The patient was treated with ZINC ongoing since an unknown date at an unspecified dose and frequency and DEXTRIN (BENEFIBER [DEXTRIN]) on 05-Sep-2021 for Adverse event, at a dose of A tablespoon daily. On 19-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. At the time of the report, HEAD INJURY (head hit the hardwood floor when passed out) outcome was unknown and FREQUENT BOWEL MOVEMENTS (still have problem / going to the bathroom 2-4 times/day) and DIARRHOEA (loose bowel/keep treating me for diarrhea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LOSS OF CONSCIOUSNESS (Passed out) to be probably related. No further causality assessments were provided for HEAD INJURY (head hit the hardwood floor when passed out), FREQUENT BOWEL MOVEMENTS (still have problem / going to the bathroom 2-4 times/day) and DIARRHOEA (loose bowel/keep treating me for diarrhea).    Patient passed out after vaccination. He went to emergency room and stayed overnight. Patient might had head injury as his head hit the hardwood floor when he passed out.  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.   This case was linked to MOD-2021-013447 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Reporter's information updated, Vaccine administration site updated, Concomitant and treatment medication added. New events Frequent bowel movements, Diarrhoea and Head injury were added. On 07-Sep-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field; 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.