Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Electrocardiogram, Loss of consciousness, Visual impairment
Clinical narrative: he had two episodes of passing out on 07Mar2021 and on 23Mar2021; COULD NOT SEE; EPISODES OF BLACKING OUT; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (EPISODES OF BLACKING OUT) and LOSS OF CONSCIOUSNESS (he had two episodes of passing out on 07Mar2021 and on 23Mar2021) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Non-smoker, Abstains from alcohol, Hysterectomy (at age of 40), Knee replacement (around age of 70s) and Hip replacement (around age of 70s). Concurrent medical conditions included Hypertension, High cholesterol, Pain, Upper respiratory infection, Dermatitis and Rheumatoid arthritis (Moderate to severe). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, RALOXIFENE for Bone disorder (NOS), DOXYCYCLINE and DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]) for Dermatitis, ATORVASTATIN for High cholesterol, AMLODIPINE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOROTHIAZIDE) and HYDROCHLOROTHIAZIDE for Hypertension, PARACETAMOL (TYLENOL) for Pain, VITAMIN E NOS for Upper respiratory disorder.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 07-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (EPISODES OF BLACKING OUT) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (COULD NOT SEE). On 23-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (he had two episodes of passing out on 07Mar2021 and on 23Mar2021) (seriousness criterion medically significant). On 07-Mar-2021, VISUAL IMPAIRMENT (COULD NOT SEE) had resolved. In 2021, LOSS OF CONSCIOUSNESS (EPISODES OF BLACKING OUT) and LOSS OF CONSCIOUSNESS (he had two episodes of passing out on 07Mar2021 and on 23Mar2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Blood pressure measurement: Normal. On 07-Mar-2021, Body temperature: Normal. On 07-Mar-2021, Electrocardiogram: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had been having episodes where patient blacked out and all tests came back negative. Patient had two episodes of passing out on 07 Mar 2021 and on 23 Mar 2021. The patient experienced blacking out after 1 week after receiving first Covid Vaccination in March. Patient did not know what was happening, patient family had to call the ambulance.  Patient went to health care professional and went to see a neurologist.  Patient was put in a heart monitor to know the reason for passed out by cardiologist. The alternative etiology for the event of could not see was reported as first episode of blacking out. The alternative etiology for the event of irritated skin was reported as adhesive from heart monitor. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of episodes of blacking out, irritated skin and could not see with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. Mft. opinion is that there is no reasonable possibility that the events of episodes of blacking out and could not see are related to humira 40mg/0.4ml(adalimumab).   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an 89-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, serious (medically significant) events of loss of consciousness (two episodes) and the unexpected, non-serious event of visual impairment. The first episode of loss of consciousness and the event visual impairment occurred 6 days after receiving the first dose of the mRNA-1273 vaccine. The second episode of loss of consciousness occurred 22 days after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient had been having episodes where she blacked out. The first episode of loss of consciousness occurred 6 days after vaccination and the patient also could not see. She did not know what was happening and her family had to call the ambulance. The patient's blood pressure (measurement was not provided) was normal and the Electrocardiogram done showed normal results. The second episode of loss of consciousness occurred 16 days after the first episode. No further details were provided until after 6 days, the patient received the second dose of the mRNA-1273 vaccine (linked case MOD-2021-635061). On an unspecified date after receiving the second dose of the mRNA-1273 vaccine, the patient sought consultation with a neurologist. The Magnetic Resonance Imaging done was unremarkable. The red blood cell count and white blood cell count were noted to be decreased (values were not provied) while the Chest X-ray was normal. The patient took Iron and vitamin B12. She also sought consultation with a cardiologist who placed a heart monitor to know the cause for her passing out. No further details were provided. The reporter stated that the alternative etiology for the event visual impairment (could not see) was the first episode of blacking out. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-635061 (Patient Link).; Sender's Comments: This spontaneous case concerns an 89-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, serious (medically significant) events of loss of consciousness (two episodes) and the unexpected, non-serious event of visual impairment. The first episode of loss of consciousness and the event visual impairment occurred 6 days after receiving the first dose of the mRNA-1273 vaccine. The second episode of loss of consciousness occurred 22 days after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient had been having episodes where she blacked out. The first episode of loss of consciousness occurred 6 days after vaccination and the patient also could not see. She did not know what was happening and her family had to call the ambulance. The patient's blood pressure (measurement was not provided) was normal and the Electrocardiogram done showed normal results. The second episode of loss of consciousness occurred 16 days after the first episode. No further details were provided until after 6 days, the patient received the second dose of the mRNA-1273 vaccine (linked case MOD-2021-635061). On an unspecified date after receiving the second dose of the mRNA-1273 vaccine, the patient sought consultation with a neurologist. The Magnetic Resonance Imaging done was unremarkable. The red blood cell count and white blood cell count were noted to be decreased (values were not provied) while the Chest X-ray was normal. The patient took Iron and vitamin B12. She also sought consultation with a cardiologist who placed a heart monitor to know the cause for her passing out. No further details were provided. The reporter stated that the alternative etiology for the event visual impairment (could not see) was the first episode of blacking out. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.