Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Tinnitus
Clinical narrative: Broke nose; Felt tingly all over; Ringing in ears; Staggered a bit; Was real sweaty; passed out 2 days in a row/ passed out but did not fall/The next morning she passed out again and was in unconsciousness; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 2 days in a row/ passed out but did not fall/The next morning she passed out again and was in unconsciousness) and FACIAL BONES FRACTURE (Broke nose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 013M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, High cholesterol, Pre-diabetes and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, METFORMIN, LOSARTAN, PRAVASTATIN, COLECALCIFEROL (VITAMIN D3) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 01-Jan-2022, the patient experienced LOSS OF CONSCIOUSNESS (passed out 2 days in a row/ passed out but did not fall/The next morning she passed out again and was in unconsciousness) (seriousness criterion medically significant), PARAESTHESIA (Felt tingly all over), TINNITUS (Ringing in ears), GAIT DISTURBANCE (Staggered a bit) and HYPERHIDROSIS (Was real sweaty). On 02-Jan-2022, the patient experienced FACIAL BONES FRACTURE (Broke nose) (seriousness criterion medically significant). The patient was treated with NAPROXEN for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out 2 days in a row/ passed out but did not fall/The next morning she passed out again and was in unconsciousness), FACIAL BONES FRACTURE (Broke nose), PARAESTHESIA (Felt tingly all over), TINNITUS (Ringing in ears), GAIT DISTURBANCE (Staggered a bit), HYPERHIDROSIS (Was real sweaty), PYREXIA (Fever) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had a booster shot on 31-Dec-2021.  On the day of the injection, she had fever and chills. On the first day she took naproxen and ibuprofen on the second day, but both did not help bring down the fever.  She passed out 2 days in a row on 01-Jan-2022 and on 02-Jan-2022.  She woke up in middle of the night, and passed out but did not fall. Afterwards, she felt tingly all over, ringing in the ears, staggered a bit and was real sweaty. The next morning she passed out again and was in unconsciousness, she broke her nose and went to the emergency room (ER). At the ER, she had an ECG test and CT scan to check her neck. The doctor diagnosed as an adverse event. No medications were prescribed. On the 3rd and 4th day, she stayed home and was feeling fine ever since. She had performed  Computerized tomogram neck and Electrocardiogram performed to check her neck. Company comment: This spontaneous case concerns a 56-year-old female patient with concomitant use of Losartan, who experienced the unexpected serious event of Loss of consciousness and Broken nose after mRNA- 1273 vaccine. The onset of the events occurred approximately 1 day after the booster dose of mRNA- 1273 vaccine. The patient passed out and broke her nose due to the fall. She was evaluated at the emergency department, electrocardiogram and Computer tomogram were performed, but the results were not provided. At the time of the report, the events had resolved. Concomitant use of Losartan remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-455272 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56-year-old female patient with concomitant use of Losartan, who experienced the unexpected serious event of Loss of consciousness and Broken nose after mRNA- 1273 vaccine. The onset of the events occurred approximately 1 day after the booster dose of mRNA- 1273 vaccine. The patient passed out and broke her nose due to the fall. She was evaluated at the emergency department, electrocardiogram and Computer tomogram were performed, but the results were not provided. At the time of the report, the events had resolved. Concomitant use of Losartan remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.