Sex: U
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Suspected Covid-19/strong covid-19 positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Suspected Covid-19/strong covid-19 positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for Prophylactic vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Concurrent medical conditions included Breast cancer, Arrhythmia cardiac (NOS) and Allergy.   On 09-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (Suspected Covid-19/strong covid-19 positive) (seriousness criterion medically significant). At the time of the report, COVID-19 (Suspected Covid-19/strong covid-19 positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive (Positive) faint Positive and positive (Positive) strong Positive.         Concomitant product use was not provided by the reporter.   On an unspecified date in 2022 (Day 11 after Paxlovid) started Covid-19 symptom (headache, sore throat, aches and pains with cough and wheezing. On same day patient had very strong positive home Covid-19 test. On 05-Jun-2022, the patient received steroids (Intravenous, oral and inhale:) for Covid-19 infection.  Company Comment: This is a spontaneous case concerning a patient of unreported age and gender with no relevant medical history, who experienced the unexpected serious AESI of COVID-19 five months after the administration of mRNA-1273 vaccine (dose number in serie 2). Patient previously vaccinated with COVID-10 Janssen´s vaccine (dose number in serie 1) approximately 8 months before Moderna vaccine. Patient was treated with NIRMATRELVIR, RITONAVIR and steroids (intravenus, oral and inhaler). The outcome is reported as not recovered. It is noted interchange of vaccine product in this case. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unreported age and gender with no relevant medical history, who experienced the unexpected serious AESI of COVID-19 five months after the administration of mRNA-1273 vaccine (dose number in serie 2). Patient previously vaccinated with COVID-10 Janssen´s vaccine (dose number in serie 1) approximately 8 months before Moderna vaccine. Patient was treated with NIRMATRELVIR, RITONAVIR and steroids (intravenus, oral and inhaler). The outcome is reported as not recovered. It is noted interchange of vaccine product in this case. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.