Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of the first episode of COVID-19 (COVID-19) and the second episode of COVID-19 (COVID-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. 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 COVID-19 prophylaxis. Concurrent medical conditions included Hypertension and Drug allergy. Concomitant products included LISINOPRIL for an unknown indication. On 21-Feb-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 10-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2022, the patient experienced the first episode of COVID-19 (COVID-19) (seriousness criterion medically significant). On 22-Jul-2022, the patient experienced the second episode of COVID-19 (COVID-19) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine Products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 09-Jul-2022 for COVID-19 treatment, at a dose of UNK, first dose evening and NIRMATRELVIR, RITONAVIR (PAXLOVID) on 14-Jul-2022 for COVID-19 treatment, at a dose of UNK, Last dose AM. At the time of the report, last episode of COVID-19 (COVID-19) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine Products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2022, SARS-CoV-2 test: (Positive) Positive. On 15-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 22-Jul-2022, SARS-CoV-2 test: (Positive) Positive. The patient received OTC (Over the counter) medication unspecified and isolation for the treatment of COVID-19. Company Comment: This is a spontaneous case concerning a 65-year-old male patient with previous COVID-19 vaccination history using one dose of the co-suspect, non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE), who experienced the unexpected, serious, adverse events of special interest, COVID-19 (reported as two episodes) which were medically significant. Approximately 2 months after receiving the 3rd schedule dose of mRNA-1273 vaccine, the patient tested positive for COVID-19 and was treated with Paxlovid, upon finishing treatment patient tested negative. However, 7 days later the patient had symptoms of COVID-19 and tested positive again. Additionally, interchange of vaccine products and COVID-19 immunization has been reported on this case. No further information on clinical course and management of the events was available in the report. The reported outcome of the events was resolving. The current COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 65-year-old male patient with previous COVID-19 vaccination history using one dose of the co-suspect, non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE), who experienced the unexpected, serious, adverse events of special interest, COVID-19 (reported as two episodes) which were medically significant. Approximately 2 months after receiving the 3rd schedule dose of mRNA-1273 vaccine, the patient tested positive for COVID-19 and was treated with Paxlovid, upon finishing treatment patient tested negative. However, 7 days later the patient had symptoms of COVID-19 and tested positive again. Additionally, interchange of vaccine products and COVID-19 immunization has been reported on this case. No further information on clinical course and management of the events was available in the report. The reported outcome of the events was resolving. The current COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.