Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vaccination site pain
Clinical narrative: Had a hot and cold feeling; Had a hot and cold feeling; Left arm was throbbing; Feeling was scary/Feels like she was hit by a truck; Fainted; Room became dizzy; left arm was throbbing; Experienced burning in the chest; Headache; Nauseousness; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced BURNING SENSATION (Experienced burning in the chest), HEADACHE (Headache) and NAUSEA (Nauseousness). On 08-Sep-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), DIZZINESS (Room became dizzy), FEELING HOT (Had a hot and cold feeling), FEELING COLD (Had a hot and cold feeling), PAIN (Left arm was throbbing), FEELING ABNORMAL (Feeling was scary/Feels like she was hit by a truck) and VACCINATION SITE PAIN (left arm was throbbing). At the time of the report, SYNCOPE (Fainted), DIZZINESS (Room became dizzy), BURNING SENSATION (Experienced burning in the chest), FEELING HOT (Had a hot and cold feeling), FEELING COLD (Had a hot and cold feeling), PAIN (Left arm was throbbing), FEELING ABNORMAL (Feeling was scary/Feels like she was hit by a truck), HEADACHE (Headache), NAUSEA (Nauseousness) and VACCINATION SITE PAIN (left arm was throbbing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Blood test: normal (normal) normal. On 08-Sep-2021, Heart rate: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab investigation includes tests, heart monitoring and took blood and test results came back normal. On 08-Sep-2021 patient had an annual mammogram scheduled at local hospital and she fainted during mammogram.  No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.  This case concerns a  45-year-old, male patient with no relevant medical history. The patient experience burning sensation, headache and nausea 1 month 2 days and, syncope, dizziness, pain in extremity ,feeling hot , feeling cold , pain , and feeling abnormal 1 month 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessment was not. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.   This case was linked to MOD-2021-312925 (Patient Link).; Sender's Comments: This case concerns a  45-year-old, male patient with no relevant medical history. The patient experience burning sensation, headache and nausea 1 month 2 days and, syncope, dizziness, pain in extremity ,feeling hot , feeling cold , pain , and feeling abnormal 1 month 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessment was not. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.