Sex: F
Vaccine: COVID19
Symptoms: Ascites, Maternal exposure during pregnancy, Muscle discomfort, Myalgia, Peripartum cardiomyopathy
Clinical narrative: Postpartum cardiomyopathy; Ascites; Muscle soarness and heaviness; Muscle soarness and heaviness; The patient found out about her pregnancy a couple of weeks after she received a Moderna booster shot, probably between 3-4 weeks pregnant at the time she received the Booster.; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of PERIPARTUM CARDIOMYOPATHY (Postpartum cardiomyopathy) and ASCITES (Ascites) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2022, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PERIPARTUM CARDIOMYOPATHY (Postpartum cardiomyopathy) (seriousness criterion medically significant), ASCITES (Ascites) (seriousness criterion medically significant), MUSCLE DISCOMFORT (Muscle soarness and heaviness), MYALGIA (Muscle soarness and heaviness) and MATERNAL EXPOSURE DURING PREGNANCY (The patient found out about her pregnancy a couple of weeks after she received a Moderna booster shot, probably between 3-4 weeks pregnant at the time she received the Booster.). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, PERIPARTUM CARDIOMYOPATHY (Postpartum cardiomyopathy), MUSCLE DISCOMFORT (Muscle soarness and heaviness), MYALGIA (Muscle soarness and heaviness) and MATERNAL EXPOSURE DURING PREGNANCY (The patient found out about her pregnancy a couple of weeks after she received a Moderna booster shot, probably between 3-4 weeks pregnant at the time she received the Booster.) had resolved and ASCITES (Ascites) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported clearly.  The patient found out about her pregnancy a couple of weeks after she received a Moderna booster shot, probably between 3-4 weeks pregnant at the time she received the Booster. She only found out about her pregnancy at the 7th week without exhibiting any symptoms.  A week after giving birth, she had experience shortness of breath and was bloated which lasted for a few months. Initial diagnosis was postpartum cardiomyopathy. Patient didn't have any history of heart failure prior to this.  Soon after, patient had ascites which was treated with diuretics.  Company Comment: This is a spontaneous case of Maternal exposure during pregnancy concerning a female patient of unknown age, with no reported medical and pregnancy history, who experienced the serious (due to medically significant) unexpected AESI of Peripartum cardiomyopathy and the serious (due to medically significant) unexpected event of Ascites, among other non-serious events. The events occurred on an unknown date after a dose of mRNA-1273 vaccine, received as the booster dose of COVID-19 vaccination schedule. The patient had received first and second dose of Moderna vaccine in 2020. Last menstrual period and estimated date of delivery were not provided; as per the reporter, who was the patient, she was probably between 3-4 weeks pregnant at the time she received the booster. She only found out about her pregnancy at the 7th week without exhibiting any symptoms. Patient reported that after the booster shot, she experienced muscle soreness and heaviness, as she experienced with first and second shot. A week after giving birth, she had experienced shortness of breath and was bloated which lasted for a few months. Initial diagnosis was postpartum cardiomyopathy. Soon after, she had ascites which was addressed with diuretics. Additional information about clinical course, supportive diagnostic procedures and treatment, were not provided. The outcome of the events was reported as recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2024-764832 (Patient Link).