Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Laboratory test, Loss of consciousness, Motor dysfunction
Clinical narrative: Passed out in shower; Lost memory/she had lost her memory; She was on the floor of the shower limp; Could not answer simple questions; Could not function; fatigue; Vaccine route SC; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in shower), AMNESIA (Lost memory/she had lost her memory), FALL (She was on the floor of the shower limp), APHASIA (Could not answer simple questions) and MOTOR DYSFUNCTION (Could not function) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery and Heart valve replacement on 23-Sep-2019. Concurrent medical conditions included Psoriasis since 2009, Penicillin allergy, Drug allergy (Fentanyl allergy), Diabetes mellitus (Diet controled DM) since 1990 and Edema. Concomitant products included TORSEMIDE for Edema, APIXABAN (ELIQUIS) from 01-Feb-2021 to an unknown date for Heart valve replacement, SECUKINUMAB (COSENTYX) for Psoriasis, METOPROLOL SUCCINATE from 23-Sep-2019 to an unknown date and POTASSIUM from 23-Oct-2019 to an unknown date for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine route SC). On 20-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in shower) (seriousness criterion hospitalization), AMNESIA (Lost memory/she had lost her memory) (seriousness criterion hospitalization), FALL (She was on the floor of the shower limp) (seriousness criterion hospitalization), APHASIA (Could not answer simple questions) (seriousness criterion hospitalization) and MOTOR DYSFUNCTION (Could not function) (seriousness criterion hospitalization). On an unknown date, the patient experienced FATIGUE (fatigue). The patient was hospitalized from 20-Feb-2021 to 21-Feb-2021 due to AMNESIA, APHASIA, FALL, LOSS OF CONSCIOUSNESS and MOTOR DYSFUNCTION. The patient was treated with Physical therapy (Physical therapy twice a week) for Motor dysfunction. On 19-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine route SC) had resolved. On 07-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out in shower) had resolved with sequelae. At the time of the report, AMNESIA (Lost memory/she had lost her memory), FALL (She was on the floor of the shower limp), APHASIA (Could not answer simple questions), MOTOR DYSFUNCTION (Could not function) and FATIGUE (fatigue) outcome was unknown. The patient was recovered with residual effects (fatigue).    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Computerised tomogram head: tia was ruled out (normal) TIA was ruled out. On 20-Feb-2021, Laboratory test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter considered LOSS OF CONSCIOUSNESS (Passed out in shower) to be related. No further causality assessments were provided for AMNESIA (Lost memory/she had lost her memory), FALL (She was on the floor of the shower limp), APHASIA (Could not answer simple questions), MOTOR DYSFUNCTION (Could not function), FATIGUE (fatigue) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine route SC).    On 19-Feb-2021, after her second vaccination, she was fine all that day. On 20-Feb-2021, she went to take shower. 20 minutes later husband of the patient check on her and found her on the floor of the shower and was not responding to his instruction and could not get her up. So, husband of the patient called an ambulance and the patient was transported to the hospital. Then 8 hours later, the patient was asking why she was in the hospital and everything was checked. There was nothing wrong but the patient was kept overnight.  She had CT of her head and TIA was ruled out, all other lab test were normal.   By the next day (21-Feb-2021), the physical therapist got her up and walked to the bathroom with a walker and she was fine. On the same day, the patient was sent home with physical therapy twice a week for 6 weeks. The patient was recovered from the event passed out in shower with residual effects (fatigue).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s medical history of heart valve replacement and concomitant use of torsemide and metoprolol succinate could be confounding factors for the events.   This case was linked to MOD-2021-300984, MOD-2021-301030 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Vaccine facility information, procedures, allergies, concomitant medications, reporter information and additional events were added. Current condition and concomitant details were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s medical history of heart valve replacement and concomitant use of torsemide and metoprolol succinate could be confounding factors for the events.