Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Crying, Dysarthria, Headache, Influenza like illness
Clinical narrative: could barely talk to the point of people understanding; to the point she was crying; she could not function. When she tried to walk, she almost passed out/someone had to grab her; Had flu like symptoms the day after receiving the second dose of the vaccine; running eyes/tears were really warm; body aches; to a point where It is nausea with the headaches; suffering from extremely bad headache/headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she could not function. When she tried to walk, she almost passed out/someone had to grab her) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A. and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE from 22-Sep-2021 to an unknown date for Blood pressure abnormal.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu like symptoms the day after receiving the second dose of the vaccine), LACRIMATION INCREASED (running eyes/tears were really warm), PAIN (body aches), NAUSEA (to a point where It is nausea with the headaches), HEADACHE (suffering from extremely bad headache/headaches) and CHILLS (chills). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (she could not function. When she tried to walk, she almost passed out/someone had to grab her) (seriousness criterion medically significant), DYSARTHRIA (could barely talk to the point of people understanding) and CRYING (to the point she was crying). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (she could not function. When she tried to walk, she almost passed out/someone had to grab her), INFLUENZA LIKE ILLNESS (Had flu like symptoms the day after receiving the second dose of the vaccine), LACRIMATION INCREASED (running eyes/tears were really warm), DYSARTHRIA (could barely talk to the point of people understanding), CRYING (to the point she was crying), PAIN (body aches), NAUSEA (to a point where It is nausea with the headaches), HEADACHE (suffering from extremely bad headache/headaches) and CHILLS (chills) outcome was unknown.            The patient did not experience any side effects after receiving first dose.; Sender's Comments: This case concerns a 56-year-old, female patient with previous relevant medical history of hypertension and use of concomitant medication, who experienced the unexpected event of loss of consciousness. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event was downgrade to non-serious due there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity or meet the criteria to be medically significant. The patient refers she almost passed out.