Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Palpitations, Vaccination complication
Clinical narrative: Having a bad reaction/ Still having a bad reaction; Rapid heart rate/ Feels it beating fast; Feels palpitations in her chest; Headache was bad; Feels hot; Cannot catch her breath due to palpitations; Cannot sleep due to palpitations; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Having a bad reaction/ Still having a bad reaction), HEADACHE (Headache was bad), HEART RATE INCREASED (Rapid heart rate/ Feels it beating fast), PALPITATIONS (Feels palpitations in her chest), FEELING HOT (Feels hot), DYSPNOEA (Cannot catch her breath due to palpitations) and INSOMNIA (Cannot sleep due to palpitations) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Celiac disease.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In July 2021, the patient experienced FEELING HOT (Feels hot) (seriousness criterion life threatening), DYSPNOEA (Cannot catch her breath due to palpitations) (seriousness criterion life threatening) and INSOMNIA (Cannot sleep due to palpitations) (seriousness criterion life threatening). On 22-Jul-2021, the patient experienced HEADACHE (Headache was bad) (seriousness criterion life threatening). On 25-Jul-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate/ Feels it beating fast) (seriousness criterion life threatening) and PALPITATIONS (Feels palpitations in her chest) (seriousness criterion life threatening). On an unknown date, the patient experienced VACCINATION COMPLICATION (Having a bad reaction/ Still having a bad reaction) (seriousness criterion life threatening). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Having a bad reaction/ Still having a bad reaction) had not resolved and HEADACHE (Headache was bad), HEART RATE INCREASED (Rapid heart rate/ Feels it beating fast), PALPITATIONS (Feels palpitations in her chest), FEELING HOT (Feels hot), DYSPNOEA (Cannot catch her breath due to palpitations) and INSOMNIA (Cannot sleep due to palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Heart rate: rapid (High) Rapid.     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.   The patient reported to the pharmacist that she was experienced headache on the first night of the date the vaccine was received which the pharmacist stated was normal but when the headache was bad, the patient took Tylenol. The patient was unable to check her pulse as per the pharmacist as the patient does not have anything to check with but feels the palpitations in her chest.   The pharmacist asked to the patient if she need to go to the urgent care and asked if the patient could receive her 2nd dose.  No treatment information provided for all the events except Headache.  The concomitant medication included blood pressure medications (but was unable to provide names).  Company comment:Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.