Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Loss of consciousness, Pyrexia, Rib fracture, Syncope
Clinical narrative: Her husband found her on the floor after she had fainted; Loss of consciousness; Spike of low blood pressure; She cracked her ribs during her fall; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Her husband found her on the floor after she had fainted) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Her husband found her on the floor after she had fainted) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), HYPOTENSION (Spike of low blood pressure), RIB FRACTURE (She cracked her ribs during her fall) and PYREXIA (Fever). At the time of the report, SYNCOPE (Her husband found her on the floor after she had fainted), LOSS OF CONSCIOUSNESS (Loss of consciousness), HYPOTENSION (Spike of low blood pressure), RIB FRACTURE (She cracked her ribs during her fall) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient received 5 doses of the Moderna COVID-19, after administration of second dose, she spiked a fever and her husband found her on the floor after she had fainted. She saw her HCP who felt she fell due to a spike of low blood pressure causing her loss of consciousness. She cracked her ribs during her fall. Company comment This spontaneous case concerns a patient of a 74-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant), events of syncope and Loss of consciousness after the second dose of mRNA-1273. It was reported that after administration of second dose, she spiked a fever and her husband found her on the floor after she had fainted. She saw her HCP who felt she fell due to a spike of low blood pressure causing her loss of consciousness. She cracked her ribs during her fall. The patient had received 2 doses of mRNA-1273 within the appropriate schedule of vaccination and then 3 doses more. No further clinical information was provided for review. Syncope and Loss of consciousness could be associated with each other. The non-serious events of hypotension and pyrexia could have led to Syncope and Loss of consciousness. Rib fracture was assessed as not related due to lack of biological plausibility and it occurred after the patient fell due to loss of consciousness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-749447.