Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Malaise, Nervousness
Clinical narrative: Sitting down after 5 minutes she started not feeling well; feeling different; felt little nervous; Headache; Heartrate rapid; Blood pressure 169/90; Shortness of breath; Felt hot blood through her body like hot oil through her body, for 1 minute; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt hot blood through her body like hot oil through her body, for 1 minute), MALAISE (Sitting down after 5 minutes she started not feeling well), FEELING ABNORMAL (feeling different) and NERVOUSNESS (felt little nervous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Rhythm nodal and Arthritis rheumatoid. Concurrent medical conditions included Arrhythmia and Hypertension. Concomitant products included CARVEDILOL, VALSARTAN, FLECAINIDE, METHOTREXATE, ADALIMUMAB (HUMIRA), ESCITALOPRAM OXALATE (LEXAPRO), BUSPIRONE and AMLODIPINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FEELING HOT (Felt hot blood through her body like hot oil through her body, for 1 minute), FEELING ABNORMAL (feeling different) and NERVOUSNESS (felt little nervous). On an unknown date, the patient experienced MALAISE (Sitting down after 5 minutes she started not feeling well). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 07-Jan-2021, FEELING HOT (Felt hot blood through her body like hot oil through her body, for 1 minute) had resolved. At the time of the report, MALAISE (Sitting down after 5 minutes she started not feeling well), FEELING ABNORMAL (feeling different) and NERVOUSNESS (felt little nervous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood pressure measurement: 169/90 (High) 169/90. On 07-Jan-2021, Heart rate: rapid (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however medical arrhythmia and hypertension was assessed as potential trigger for blood pressure increased as well as for heart rate increased.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant Follow-up Contains Patient demographic details,new concomitant medications added & new events also added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however medical arrhythmia and hypertension was assessed as potential trigger for blood pressure increased as well as for heart rate increased.