Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: I passed out; my legs were uncontrollable; They were weak; They were shaking; my blood pressure went up to about 160 over something; I had a fever of 102°F; I began vomiting; my body was sore; I had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I passed out) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (I passed out) (seriousness criterion medically significant), LIMB DISCOMFORT (my legs were uncontrollable), MUSCULAR WEAKNESS (They were weak), TREMOR (They were shaking), BLOOD PRESSURE INCREASED (my blood pressure went up to about 160 over something), PYREXIA (I had a fever of 102°F), VOMITING (I began vomiting), MYALGIA (my body was sore) and VACCINATION SITE PAIN (I had a sore arm at the injection site). At the time of the report, LOSS OF CONSCIOUSNESS (I passed out), LIMB DISCOMFORT (my legs were uncontrollable), MUSCULAR WEAKNESS (They were weak), TREMOR (They were shaking), BLOOD PRESSURE INCREASED (my blood pressure went up to about 160 over something), PYREXIA (I had a fever of 102°F), VOMITING (I began vomiting), MYALGIA (my body was sore) and VACCINATION SITE PAIN (I had a sore arm at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Blood pressure measurement: went up to about 160 (High) blood pressure went up to about 160 over something. On 23-Feb-2021, Body temperature: 102 (High) 102°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  22Feb2021: I got the 2nd dose of the Moderna Covid-19 vaccine around 8p.  Company comment:This case concerns a  77-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable as event occurred after the second dose of Moderna COvid-19 vaccine. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.   This case was linked to MOD-2021-328683 (Patient Link).; Sender's Comments: This case concerns a  77-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable as event occurred after the second dose of Moderna COvid-19 vaccine. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.