Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness postural, Dyspnoea, Dysstasia, Fall
Clinical narrative: Passed out/Fell out on a concrete and loss consciousness/Thought she had died and was in heaven/She did not know anybody until the next morning at; Fell out on a concrete; Hard for her to breath/ Breathing at 50%/ She was on the ventilator machine for 3 days; Can't function or do anything without feeling like she will fall; Can't work to make ends meet/ can't hold anything like a can of soda longer than 2 minutes.; It's like she will faint when she stands up from a sitting position; Lightheaded when she stands after sitting; injection which started burning; Feeling really really bad/Thought she had died and was in heaven; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out/Fell out on a concrete and loss consciousness/Thought she had died and was in heaven/She did not know anybody until the next morning at), FALL (Fell out on a concrete) and DYSPNOEA (Hard for her to breath/ Breathing at 50%/ She was on the ventilator machine for 3 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009B21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced FEELING ABNORMAL (Feeling really really bad/Thought she had died and was in heaven). On 01-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out/Fell out on a concrete and loss consciousness/Thought she had died and was in heaven/She did not know anybody until the next morning at) (seriousness criteria hospitalization and medically significant) and FALL (Fell out on a concrete) (seriousness criteria hospitalization and medically significant). In July 2021, the patient experienced DYSPNOEA (Hard for her to breath/ Breathing at 50%/ She was on the ventilator machine for 3 days) (seriousness criterion hospitalization). On an unknown date, the patient experienced ASTHENIA (Can't function or do anything without feeling like she will fall), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't work to make ends meet/ can't hold anything like a can of soda longer than 2 minutes.), DYSSTASIA (It's like she will faint when she stands up from a sitting position), DIZZINESS POSTURAL (Lightheaded when she stands after sitting) and VACCINATION SITE PAIN (injection which started burning). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out/Fell out on a concrete and loss consciousness/Thought she had died and was in heaven/She did not know anybody until the next morning at), FALL (Fell out on a concrete), DYSPNOEA (Hard for her to breath/ Breathing at 50%/ She was on the ventilator machine for 3 days), ASTHENIA (Can't function or do anything without feeling like she will fall), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't work to make ends meet/ can't hold anything like a can of soda longer than 2 minutes.), DYSSTASIA (It's like she will faint when she stands up from a sitting position), FEELING ABNORMAL (Feeling really really bad/Thought she had died and was in heaven), DIZZINESS POSTURAL (Lightheaded when she stands after sitting) and VACCINATION SITE PAIN (injection which started burning) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  The reporter states that the patient received 2nd dose on 14-Jun-2021, around 17-Jun-2021 patient stated feeling bad and lightheaded when patient stands after sitting, patient once passed out but cannot remember the date, On 01-Jul-2021 at around 5 in the evening, patient fell out on a concrete and loss consciousness. Patient was taken to the Emergency room at Hospital, patient do not knowanybody until the next morning at around 3:30 and reporter states that It was so hard for patient to breath, patient was on  the ventilator machine for 3 days. Patient delayed getting the 2nd dose because of patient arm had not healed from the 1st dose.  This case concerns a 67 year-old, female patient with no relevant medical history, who experienced the unexpected events of Loss of consciousness, Fall and dyspnoea. The events Loss of consciousness and Fall occurred approximately 17 days after the second dose of Moderna COVID-19 vaccine and the event dyspnoea occurred on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-311028.; Sender's Comments: This case concerns a 67 year-old, female patient with no relevant medical history, who experienced the unexpected events of Loss of consciousness, Fall and dyspnoea. The events Loss of consciousness and Fall occurred approximately 17 days after the second dose of Moderna COVID-19 vaccine and the event dyspnoea occurred on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.