Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: She has no neurological damage but has some bumps and memory problems; she has a concussion; she had passed out in the kitchen/She fainted 2 times; Patient says she received Spikevax on 11Oct2023 and then she felt like a little weak; She got into bed with chills and feeling achy; she felt like "crap"/She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic; She got into bed with chills; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (she had passed out in the kitchen/She fainted 2 times) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (the original strain, she had a cough, felt achy, had fever, felt like having the flu and felt like having 200 extra pounds in her body.) in March 2020 and Passed out (she passed out in the kitchen.) in March 2020. Previously administered products included for Product used for unknown indication: Flu vaccine 25Sep on 25-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine 25Sep. Concurrent medical conditions included Allergy to antibiotic since 2023.    On 11-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Oct-2023, the patient experienced ASTHENIA (Patient says she received Spikevax on 11Oct2023 and then she felt like a little weak), MYALGIA (She got into bed with chills and feeling achy), FEELING ABNORMAL (she felt like "crap"/She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic) and CHILLS (She got into bed with chills). On 12-Oct-2023, the patient experienced LOSS OF CONSCIOUSNESS (she had passed out in the kitchen/She fainted 2 times) (seriousness criterion medically significant), MEMORY IMPAIRMENT (She has no neurological damage but has some bumps and memory problems) and CONCUSSION (she has a concussion). At the time of the report, LOSS OF CONSCIOUSNESS (she had passed out in the kitchen/She fainted 2 times) outcome was unknown and ASTHENIA (Patient says she received Spikevax on 11Oct2023 and then she felt like a little weak), MYALGIA (She got into bed with chills and feeling achy), MEMORY IMPAIRMENT (She has no neurological damage but has some bumps and memory problems), CONCUSSION (she has a concussion), FEELING ABNORMAL (she felt like "crap"/She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic) and CHILLS (She got into bed with chills) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered LOSS OF CONSCIOUSNESS (she had passed out in the kitchen/She fainted 2 times) to be related. No further causality assessments were provided for ASTHENIA (Patient says she received Spikevax on 11Oct2023 and then she felt like a little weak), MYALGIA (She got into bed with chills and feeling achy), MEMORY IMPAIRMENT (She has no neurological damage but has some bumps and memory problems), CONCUSSION (she has a concussion), FEELING ABNORMAL (she felt like "crap"/She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic) and CHILLS (She got into bed with chills).    The patient received first dose: Moderna 012M20A - 28-Jan-2021 second dose: Moderna 014M20A - 25-Feb-2021 third dose: Moderna 012F21A - 22-Oct-2021 forth dose: Moderna 048L21A - 01-Apr-2022 fifth dose: Moderna AS7144B - 07-Sep-2022 sixth dose: Moderna AS7644C - 11-Aug-2023. After receiving Spikevax, she felt not quite herself. She did not faint, she was not shaking, she went home. She got into bed with chills and feeling achy - which was normal for her. Next morning: she felt like "crap". She went to the kitchen to take an Advil - next thing she remembered was someone was slapping her face trying to wake her up. It was her husband trying to wake her up, she had passed out in the kitchen. Her head bounced over the kitchen counter and she has a concussion. She ended up in the hospital, in the emergency room. She felt the exact same feeling when she got covid then when she received Spikevax. So, she was sure this had to do with the vaccine. She fainted 2 times in her entire life. She stated now she was scared to death. Company comment: This spontaneous case concerns a 68-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (medically significant) event of LOSS OF CONSCIOUSNESS, on the following day of the seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, among other non serious events. She has no neurological damage but has some bumps and memory problems. Considering the nature of event and non-suggestive relation causality CONCUSSION was assessed as not related, as it occurred as a consequence of loss of consciousness. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to MOD-2023-747068 (Patient Link).