Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Maternal exposure during pregnancy, Palpitations, Pericarditis, SARS-CoV-2 test
Clinical narrative: diagnosed with pericarditis from the booster shot; heart started racing (booster)/heart rate was 151 BPM (walking)/resting heart rate is 105 BPM; little bit of chest tightness; trouble breathing; coughing; hard to sleep at night; headache; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PERICARDITIS (diagnosed with pericarditis from the booster shot) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral valve prolapse (Patient has experienced heart palpitations in the past from Mitral Valve Prolapse (MVP).) and COVID-19 (COVID infection caused chest tightness.Recovered from COVID-19 after 10 days) on 01-Dec-2021. Concurrent medical conditions included Allergy (allergies), Barrett's esophagus and Asthma (severe 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 16-Jan-2022, the patient received third 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 was 13-May-2022. On 16-Jan-2022, the patient experienced PALPITATIONS (heart started racing (booster)/heart rate was 151 BPM (walking)/resting heart rate is 105 BPM), CHEST DISCOMFORT (little bit of chest tightness), DYSPNOEA (trouble breathing), COUGH (coughing), INSOMNIA (hard to sleep at night), HEADACHE (headache) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced PERICARDITIS (diagnosed with pericarditis from the booster shot) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. On 16-Jan-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, PERICARDITIS (diagnosed with pericarditis from the booster shot), PALPITATIONS (heart started racing (booster)/heart rate was 151 BPM (walking)/resting heart rate is 105 BPM), CHEST DISCOMFORT (little bit of chest tightness), DYSPNOEA (trouble breathing), COUGH (coughing), INSOMNIA (hard to sleep at night) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, SARS-CoV-2 test: positive (Positive) Patient was diagnosed with COVID-19 infection. In 2022, Heart rate: 151 bpm Walking heart rate was 151 BPM and 105 bpm resting heart rate was 105 BPM.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that couple of hours after receiving the booster dose, heart started racing. She also reported a little bit of chest tightness with a deep breath, trouble breathing, coughing and headache. Patient also reported it was hard to sleep at night.   She was diagnosed with COVID-19 infection on 01Dec2021. She reported the COVID infection caused chest tightness. Patient was not hospitalized, was not given antibody treatment for COVID-19 infection. She reported she has experienced heart palpitations in the past from Mitral Valve Prolapse.  Caller stated she is pregnant, she is having a baby boy.    Treatment medication was reported for headache (Tynelol) and for rest of events it was not reported.  Company comment: This is a case of maternal exposure during pregnancy for this 35-year-old female patient with medical history of Mitral valve prolapse and COVID-19 diagnosed on 01-Dec-2021; who experienced serious (medically significant), expected, AESI event of pericarditis. It was reported that after the third dose of mRNA-1273 vaccine she developed palpitations, chest discomfort, cough and dyspnea and emergency room doctors diagnosed her with pericarditis. No further details regarding diagnostic tests or treatment performed were disclosed. The patient's last menstrual period was on an unknown date and the estimated date of delivery is 13-May-2022. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-453882, MOD-2022-453536 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Significant follow-up document was received on 31-JAN-2022-Case seriousness was upgraded. New event(Pericarditis) was added.. Historical condition(COVID-19), Lab data were added in patient tab. Barret's esophagus was changed to current condition.; Sender's Comments: This is a case of maternal exposure during pregnancy for this 35-year-old female patient with medical history of Mitral valve prolapse and COVID-19 diagnosed on 01-Dec-2021; who experienced serious (medically significant), expected, AESI event of pericarditis. It was reported that after the third dose of mRNA-1273 vaccine she developed palpitations, chest discomfort, cough and dyspnea and emergency room doctors diagnosed her with pericarditis. No further details regarding diagnostic tests or treatment performed were disclosed. The patient's last menstrual period was on an unknown date and the estimated date of delivery is 13-May-2022. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.