Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Feeling abnormal, Feeling hot, Headache
Clinical narrative: Shortness of breath; Sitting down after 5 minutes she started not feeling well; Felt warm feeling from head to toe; Within 5-10 minutes she started feeling different; Heart rate elevated; Blood pressure elevated; nervousness; Missed Dose; Experiencing headache that lasted for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), MALAISE (Sitting down after 5 minutes she started not feeling well), FEELING HOT (Felt warm feeling from head to toe), FEELING ABNORMAL (Within 5-10 minutes she started feeling different) and HEART RATE INCREASED (Heart rate elevated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia (Rhythm problem.). Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA), CARVEDILOL, VALSARTAN, FLECAINIDE, AMLODIPINE, BUSPIRONE HYDROCHLORIDE, METHOTREXATE and ESCITALOPRAM OXALATE (LEXAPRO) 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 an unknown date, the patient experienced DYSPNOEA (Shortness of breath), MALAISE (Sitting down after 5 minutes she started not feeling well), FEELING HOT (Felt warm feeling from head to toe), FEELING ABNORMAL (Within 5-10 minutes she started feeling different), HEART RATE INCREASED (Heart rate elevated), HYPERTENSION (Blood pressure elevated), NERVOUSNESS (nervousness), HEADACHE (Experiencing headache that lasted for 5 days) and PRODUCT DOSE OMISSION ISSUE (Missed Dose). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), MALAISE (Sitting down after 5 minutes she started not feeling well), FEELING HOT (Felt warm feeling from head to toe), FEELING ABNORMAL (Within 5-10 minutes she started feeling different), HEART RATE INCREASED (Heart rate elevated), HYPERTENSION (Blood pressure elevated) and NERVOUSNESS (nervousness) outcome was unknown and HEADACHE (Experiencing headache that lasted for 5 days) and PRODUCT DOSE OMISSION ISSUE (Missed Dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Elevated blood pressure. Systolic pressure- 180.. On an unknown date, Heart rate: increased (High) Increased. On an unknown date, Viral titre: 15 (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In was reported that patient went to ER, was monitored and performed test to make sure it was not a heart attack.  Tropine test was done IV bolus was given to the patient. Patient got discharge from ER after 7 hours. Patients primary HCP did a titer test and result  was low less than 15. 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.; 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.