Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Drug ineffective, Palpitations, Vaccination complication
Clinical narrative: COVID-19 infection; Lack of drug effect; chest tightness; heart raced; Experiencing a reaction from the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PALPITATIONS (heart raced), VACCINATION COMPLICATION (Experiencing a reaction from the vaccine), COVID-19 (COVID-19 infection), CHEST DISCOMFORT (chest tightness) and DRUG INEFFECTIVE (Lack of drug effect) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse (Patient reported she has experienced heart palpitations in the past from Mitral Valve Prolapse (MVP).) and Barrett's esophagus. Concurrent medical conditions included Allergy (allergies) and Asthma. Concomitant products included EPINEPHRINE BITARTRATE (ASTHMAHALER) for Asthma, PANTOPRAZOLE for Barrett's esophagus, ASPIRIN [ACETYLSALICYLIC ACID] for Pre-eclampsia, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FLUOXETINE for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery unknown. On 26-Mar-2021, the patient experienced PALPITATIONS (heart raced) and VACCINATION COMPLICATION (Experiencing a reaction from the vaccine). On 01-Dec-2021, the patient experienced COVID-19 (COVID-19 infection) and DRUG INEFFECTIVE (Lack of drug effect). In December 2021, the patient experienced CHEST DISCOMFORT (chest tightness). At the time of the report, PALPITATIONS (heart raced) and COVID-19 (COVID-19 infection) had resolved and VACCINATION COMPLICATION (Experiencing a reaction from the vaccine), CHEST DISCOMFORT (chest tightness) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  Patient stated she was diagnosed with COVID-19 infection on 01-Dec-2021. She reported the COVID infection caused chest tightness.  Patient stated she recovered from COVID-19 after 10 days.  She was not hospitalized. She was not given any antibody treatment. Patient was exposed again to COVID-19 on 25-Dec-2021, but she did not become infected this time.  Patient stated after leaving the emergency room, eventually her heart stopped racing on its own.  Company comment: This is a spontaneous case concerning a 35-year-old pregnant female patient (Gestation period 6 months) with medical history of mitral valve prolapse, who experienced the non-serious, unexpected, according RA, AESI event of COVID-19 and other non-serious events. The event COVID-19 occurred approximately 8 months and 5 days after the second dose of mRNA-1273 vaccine and resolved in 10 days. The medical history of mitral valve prolapse remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-453536, MOD-2022-453883 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 35-year-old pregnant female patient (Gestation period 6 months) with medical history of mitral valve prolapse, who experienced the non-serious, unexpected, according RA, AESI event of COVID-19 and other non-serious events. The event COVID-19 occurred approximately 8 months and 5 days after the second dose of mRNA-1273 vaccine and resolved in 10 days. The medical history of mitral valve prolapse remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.