Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Cold sweat, Dizziness
Clinical narrative: Passed out; Hit the floor flat out prone on my back, husband found me on the floor/fell on thumb first/Sore hip and back from hitting the floor; Felt clammy; Sweaty while in bed; Hard time eating; Felt hot; Have no energy; Sore hip and back from hitting the floor; Felt lightheaded; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 65-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 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Allergy to chemicals (Thimerosal) and Penicillin allergy. Concomitant products included AMLODIPINE for Blood pressure high.    On 21-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Nov-2022, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), FALL (Hit the floor flat out prone on my back, husband found me on the floor/fell on thumb first/Sore hip and back from hitting the floor), COLD SWEAT (Felt clammy), HYPERHIDROSIS (Sweaty while in bed), FEEDING DISORDER (Hard time eating), FEELING HOT (Felt hot), ASTHENIA (Have no energy), BACK PAIN (Sore hip and back from hitting the floor), DIZZINESS (Felt lightheaded) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Nov-2022, LOSS OF CONSCIOUSNESS (Passed out), FALL (Hit the floor flat out prone on my back, husband found me on the floor/fell on thumb first/Sore hip and back from hitting the floor), COLD SWEAT (Felt clammy), HYPERHIDROSIS (Sweaty while in bed), FEEDING DISORDER (Hard time eating), FEELING HOT (Felt hot), ASTHENIA (Have no energy), BACK PAIN (Sore hip and back from hitting the floor), DIZZINESS (Felt lightheaded) and NAUSEA (Nauseous) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2022, Body temperature: 98.2.         The canadian Patient had called to report side effects after Receiving Moderna Bivalent. The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Patient received first dose on 5-Mar-2021 intramuscularly with lot number 636A21A, second dose on 2-Apr-2021 with lot number 028A21A, first booster on 1-Dec-2021 with lot number 067F21A, second booster on 11-Apr-2022 with lot number 002M21A.  On 22-Nov-2022, patient felt lightheaded, passed out, hit the floor flat out prone on her back, husband found her on the floor, felt clammy, sweaty while in bed, nauseous, hard time eating. felt hot, but temperature showed 98.2, sore hip and back from hitting the floor, fell on thumb first, had no energy.  The AE did not cause patient to seek medical care, only contacted pharmacy. The AE Outcome reported as residual, lasted 1 day. The patient was feeling better, but not that great.  Company comment- This spontaneous case concerns a 65-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) event of Loss of consciousness 1 day after vaccination with a fifth dose of mRNA-1273.222. The patient reported the following day after vaccination, she experienced lightheadedness and passed out on the floor, flat out prone on her back. She complained of feeling clammy, was sweaty while in bed, nauseous, she had a hard time eating. felt hot (but temperature showed 98.2), had a sore hip and back from hitting the floor, and have no energy. The outcome of the events was reported as resolved with sequelae. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) event of Loss of consciousness 1 day after vaccination with a fifth dose of mRNA-1273.222. The patient reported the following day after vaccination, she experienced lightheadedness and passed out on the floor, flat out prone on her back. She complained of feeling clammy, was sweaty while in bed, nauseous, she had a hard time eating. felt hot (but temperature showed 98.2), had a sore hip and back from hitting the floor, and have no energy. The outcome of the events was reported as resolved with sequelae. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.