Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Patient had covid infection (dose number in series 3); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had covid infection (dose number in series 3)) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 Crohn's disease, Gluten sensitivity and Depression. Concomitant products included BUPROPION for Depression.   On 11-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 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022, the patient experienced COVID-19 (Patient had covid infection (dose number in series 3)) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 28-May-2022 to 01-Jun-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient had covid infection (dose number in series 3)) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 08-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         It was unknown whether patient had any adverse events following spikevax (dose number in series 2). On 25-May-2022 It was confirmed clinical vaccination failure (dose number in series 1). On 28-May-2022 patient took paxlovid as treatment for covid 19.  On 01-Jun-2022 patient took last dose of paxlovid and COVID was recovered. On 08-Jun-2022 at 7:00 AM, the patient experienced COVID-19 infection and return of symptoms which included mostly congestion and extreme fatigue (dose number 3). Company comment: This spontaneous case concerns a 35-year-old male patient, with no relevant medical history, who experienced the unexpected serious (due to medically significant) AESI of COVID-19, two months after the last dose of mRNA-1273 vaccine. Patient received previously a dose of JANSSEN COVID-19 VACCINE as the first dose in the vaccine schedule, and mRNA-1273 vaccine as the second and third doses of the vaccination series (Interchange of vaccine products). Two positive SARS-CoV-2 tests were performed 2 and 3 months after the last dose of mRNA-1273 vaccine, and he received Paxlovid as COVID-19 treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Follow-Up included medical history, co-suspect and treatment medication added. Seriousness Criteria Upgraded.; Sender's Comments: This spontaneous case concerns a 35-year-old male patient, with no relevant medical history, who experienced the unexpected serious (due to medically significant) AESI of COVID-19, two months after the last dose of mRNA-1273 vaccine. Patient received previously a dose of JANSSEN COVID-19 VACCINE as the first dose in the vaccine schedule, and mRNA-1273 vaccine as the second and third doses of the vaccination series (Interchange of vaccine products). Two positive SARS-CoV-2 tests were performed 2 and 3 months after the last dose of mRNA-1273 vaccine, and he received Paxlovid as COVID-19 treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.