Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Syncope
Clinical narrative: Severe cold; Cough; Lethargy; Congestion; faint; Rebound COVID-19; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (faint), COVID-19 (Rebound COVID-19), NASOPHARYNGITIS (Severe cold), COUGH (Cough) and LETHARGY (Lethargy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 011A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herpes NOS, Fistula anal and Cholecystectomy. Previously administered products included for Drug use for unknown indication: Benadryl. Past adverse reactions to the above products included Drug allergy with Benadryl. Concurrent medical conditions included Blood pressure high, Obesity, Mitral valve prolapse, Polycystic ovarian syndrome, Depression, Anxiety and Ex-smoker. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), VALACICLOVIR HYDROCHLORIDE (VALTREX), NIFEDIPINE, MINERALS NOS, VITAMINS NOS (PRENATAL PLUS), CALCIUM and LYSINE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, the patient experienced COVID-19 (Rebound COVID-19). On 30-May-2022, the patient experienced SYNCOPE (faint), NASOPHARYNGITIS (Severe cold), COUGH (Cough), LETHARGY (Lethargy) and NASAL CONGESTION (Congestion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 27-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, SYNCOPE (faint), COVID-19 (Rebound COVID-19), NASOPHARYNGITIS (Severe cold), COUGH (Cough), LETHARGY (Lethargy) and NASAL CONGESTION (Congestion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient had rebound COVID-19 ingestion 11 days after first symptoms and three days after completing paxlovid.  Company comment: This is a spontaneous case concerning a 38-year-old female  patient with medical history of obesity mitral valve prolapse, blood pressure high and polycystic ovarian syndrome, among others, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 5 months after the third dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. Patient was treated with Paxlovid for 5 days.  Rebound covid-19 with a rapid positive test was reported 11 days after first symptoms and 3 days after completing paxlovid. Symptoms included severe cold, cough, lethargy, congestion and syncope . The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 38-year-old female  patient with medical history of obesity mitral valve prolapse, blood pressure high and polycystic ovarian syndrome, among others, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 5 months after the third dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. Patient was treated with Paxlovid for 5 days. Rebound covid-19 with a rapid positive test was reported 11 days after first symptoms and 3 days after completing paxlovid. Symptoms included severe cold, cough, lethargy, congestion and syncope . The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.