Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Balance disorder, Laboratory test, Loss of personal independence in daily activities, Unresponsive to stimuli
Clinical narrative: Found unresponsive; Patient had someone to stay with to assist, because patient balance was way off; Patient not at the level of energy that used to be; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2023 and was forwarded to Moderna on 24-Mar-2023.    This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Found unresponsive) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose, Lot : 007B21A) on 18-May-2021, Moderna COVID-19 Vaccine (2nd dose, Lot : 007131A) on 15-Jul-2021, Moderna COVID-19 Vaccine (1st booster, Lot : 084J21A) on 25-Jan-2022, Moderna COVID-19 Vaccine (2nd booster and Lot : 038A22A) on 25-Jul-2022; for Product used for unknown indication: INFLUENZA VACCINE; for Drug use for unknown indication: ZOSTER. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and ZOSTER.    On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Mar-2023, the patient experienced BALANCE DISORDER (Patient had someone to stay with to assist, because patient balance was way off) and ASTHENIA (Patient not at the level of energy that used to be). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Found unresponsive) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in November 2022 to sometime in November 2022 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (Found unresponsive) outcome was unknown and BALANCE DISORDER (Patient had someone to stay with to assist, because patient balance was way off) and ASTHENIA (Patient not at the level of energy that used to be) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient was found unresponsive  and was in hospital for 8 or 9 days. Patient had lot of test. Patient doctor said it could had been caused by the Covid-19 vaccine. Patient had to have PT & home health nurse. No treatment information was provided.  Company comment: This spontaneous case concerns a 51-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant and hospitalization) event of loss of consciousness 5 months after the fifth dose of mRNA-1273.222. Patient was found unresponsive and was admitted to the hospital for 8 or 9 days, after which she reports she need someone to assist her because her balance is off and has asthenia. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to MOD-2023-716933 (Patient Link).