Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Tachycardia on exertion; shortness of breath; This spontaneous pregnancy case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia on exertion) and DYSPNOEA (shortness of breath) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 027A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy and Tachycardia (History of tachycardia with previous pregnancy treated with beta blocker.) on 29-Dec-2020.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 29-Dec-2020, the patient experienced TACHYCARDIA (Tachycardia on exertion) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath) (seriousness criterion medically significant). On 06-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Dec-2020, TACHYCARDIA (Tachycardia on exertion) and DYSPNOEA (shortness of breath) had resolved. On 06-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Blood test: inconclusive (Inconclusive) CBC, TSH, and CMP. On 29-Dec-2020, Cardiac monitoring: inconclusive (Inconclusive) Inconclusive. On 29-Dec-2020, Chest X-ray: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment reported was not reported/ unknown.  This is a case of product exposure during pregnancy associated  with tachycardia on exertion and dyspnea for this 25-year-old female. Patient has a history of tachycardia with previous pregnancy treated with beta blocker. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   The causality of the event of inappropriate schedule of vaccine administered is assessed as Not applicable.   Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during pregnancy associated  with tachycardia on exertion and dyspnea for this 25-year-old female. Patient has a history of tachycardia with previous pregnancy treated with beta blocker. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   The causality of the event of inappropriate schedule of vaccine administered is assessed as Not applicable.