Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, Nucleic acid test, SARS-CoV-2 test
Clinical narrative: Experienced COVID-19 symptoms/COVID -19 infection; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Experienced COVID-19 symptoms/COVID -19 infection) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    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.   On 08-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 14-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 10-May-2022, the patient experienced COVID-19 (Experienced COVID-19 symptoms/COVID -19 infection) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Experienced COVID-19 symptoms/COVID -19 infection) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, Nucleic acid test: positive (Positive) Positive. On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The age at the time of COVID-19 vaccine Janssen was 43 years. The date of birth of patient was reported as unknown date Jun-1977.  No concomitant medication was provided by reporter.  On 10-May-2022 approximately 13 months after Janssen vaccine, clinical vaccine failure happened.  For Janssen, reporter causality was possible, causality as per Mfr. was possible.   This report was associated with product quality complaint: 90000234197  Company comment-This spontaneous case concerns a male patient aged 44 years with no relevant medical history reported, who experienced the unexpected serious medically significant AESI of Covid 19 approximately 177 days after receiving a dose (2nd dose) of mRNA-1273 vaccine in the covid 19 vaccination series. Additionally Interchange of vaccine products was noted as patient had received a dose of vaccination with co suspect JANSSEN COVID-19 VACCINE 220 days  prior to current vaccination. Patient had initial covid -19 symptoms, next day Nucleic acid amplification test was positive, started treatment with Paxlovid for 6 days. Outcome of the event Covid 19 was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 44 years with no relevant medical history reported, who experienced the unexpected serious medically significant AESI of Covid 19 approximately 177 days after receiving a dose (2nd dose) of mRNA-1273 vaccine in the covid 19 vaccination series. Additionally Interchange of vaccine products was noted as patient had received a dose of vaccination with co suspect JANSSEN COVID-19 VACCINE 220 days  prior to current vaccination. Patient had initial covid -19 symptoms, next day Nucleic acid amplification test was positive, started treatment with Paxlovid for 6 days. Outcome of the event Covid 19 was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.