Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Confirmed Covid-19 infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Confirmed Covid-19 infection) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    Concurrent medical conditions included Allergy to nuts (Tree nut allergy). Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 08-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Confirmed Covid-19 infection) (seriousness criterion medically significant). The patient was treated with RITONAVIR from 20-Apr-2022 to 25-Apr-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Confirmed Covid-19 infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         Cocomitant medications included tissue rejuvenator.  On unspecified date on 2022, the patient experienced confirmed clinical vaccination failure with dose number in series 1. It was reported that on unknown date patient was tested negative for covid-19 after 10 days. On 01-May-2022 stated that patient had more severe symptoms reoccurred ( coded to confirmed covid-19 infection) (dose numder in series 2). Patient reported that he assumed the symptoms were something else and infected patient's partner as he was no longer isolating and on unknown date patient was tested pasitive again on day 16. This report was associated wit product quality complaint: 90000231245.  The reporter and Mfr. causality for Janssen Covid-19 vaccine for the events confirmed Covid-19 infection and confirmed clinical vaccination failure was reported as possible. Confirmed clinical vaccination failure event has a compatible/ suggestive temporal relationship, was labelled, and as unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: Special situations. Therefore, thus event(s) was considered not related. COMPANY COMMENT: This is an spontaneous case concerning a 52-years-old male patient with medical history of Allergy to nuts, Concomitant products included PARACETAMOL and IBUPROFEN, first dose of JANSSEN COVID-19 VACCINE on 08-Mar-2021, RITONAVIR from 20-Apr-2022 to 25-Apr-2022 for COVID-19  who experienced the unexpected  event of COVID-19  (seriousness criterion medically significant) in the context of  2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is an spontaneous case concerning a 52-years-old male patient with medical history of Allergy to nuts, Concomitant products included PARACETAMOL and IBUPROFEN, first dose of JANSSEN COVID-19 VACCINE on 08-Mar-2021, RITONAVIR from 20-Apr-2022 to 25-Apr-2022 for COVID-19  who experienced the unexpected  event of COVID-19  (seriousness criterion medically significant) in the context of  2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.