Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: blood pressure fluctuation; severe headache; heart started racing; felt like my body was vibrating; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart started racing), FEELING ABNORMAL (felt like my body was vibrating), BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (severe headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM for Adverse event.    No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE SODIUM (Oral) 130 mcg once a day. On 28-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 10-Feb-2021, the patient experienced PALPITATIONS (heart started racing) and FEELING ABNORMAL (felt like my body was vibrating). On 15-Feb-2021, the patient experienced HEADACHE (severe headache). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation). On 31-Jan-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, PALPITATIONS (heart started racing), FEELING ABNORMAL (felt like my body was vibrating), BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 163/100 mmHg (High) Increased and 101/80 mmHg (Low) Decreased.         No relevant concomitant medications were reported. No treatment information was reported. Patient initially administered 130 mcg of T 3, after taking it her heart started racing and her doctor suggested to drop the dose of drug to 5 mcg orally daily and then her blood pressure was dropped to 163/100 to 101/80 and later physician totally discontinued the T-3.; Sender's Comments: This report concerns a 61 year old female patient who experienced flu like symptoms (on the same day), palpitations, abnormal feeling (13 days), headache and blood pressure fluctuation (18 days) after vaccination with second dose of mRNA-1273. The patient was on concomitant daily oral levothyroxine therapy (T3) 130 mcg. In view of her symptoms, the physician decreased the dosage to 125 mcg daily, then to 110 mcg and finally discontinued the drug. The patient reported resolution of symptoms upon discontinuation of levothyroxine. Based on the available information, the concomitant therapy with levothyroxine remains a confounder for the reported events of palpitations, blood pressure fluctuation and abnormal feeling. The benefit-risk relationship of mRNA-1273 is not affected by this report.