Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (A week later, had COVID symptoms again and tested positive for another full week/ confirmed COVID-19 infection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 007J21-2A) 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 Blood pressure high, Drug allergy (Morphine allergy) and Allergy to wool. Concomitant products included LISINOPRIL, CALCIUM, COLECALCIFEROL (CALCIUM WITH VITAMIN D3 [CALCIUM;COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 13-Mar-2021 at 4:00 PM, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 28-Oct-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021 at 11:00 AM, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On an unknown date, the patient experienced COVID-19 (A week later, had COVID symptoms again and tested positive for another full week/ confirmed COVID-19 infection) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 09-Jun-2022, COVID-19 (A week later, had COVID symptoms again and tested positive for another full week/ confirmed COVID-19 infection) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):  On 20-May-2022, SARS-CoV-2 test: Positive. On 26-May-2022, SARS-CoV-2 test: Negative. On 02-Jun-2022, SARS-CoV-2 test: (Positive) Tested positive for another full week until 09-Jun-2022. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. On an unspecified date, the patient felt sick and tested positive for COVID on 20-May-2022. The patient started taking Paxlovid as prescribed by the doctor that same day. After completion of the 5 day anti viral, patient tested negative. The product complaint number for JANSSEN COVID-19 vaccine was 90000237576. Company comment: This is a spontaneous case concerns a 67-years-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) adverse events of special interest, COVID-19 (COVID-19) which occurred on unspecified day after receiving the third dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positive on 20-May-2022, until for another full week until 09-Jun-2022. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment and event was resolved. It was noted that patient received a dose with COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE)1 year 24 days prior to current vaccination (interchange of vaccine products) and received a dose with mRNA1273 vaccine as second dose approximately 5 months prior to current vaccination. Ongoing Covid 19 pandemic and co-suspect could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. Most recent FOLLOW-UP information incorporated above includes. On 12-Jul-2022: Significant Follow Up received, updated event seriousness criteria and suspect product information. Sender's Comments: This is a spontaneous case concerns a 67-years-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) adverse events of special interest, COVID-19 (COVID-19) which occurred on unspecified day after receiving the third dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positive on 20-May-2022, until for another full week until 09-Jun-2022. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment and event was resolved. It was noted that patient received a dose with COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE)1 year 24 days prior to current vaccination (interchange of vaccine products) and received a dose with mRNA1273 vaccine as second dose approximately 5 months prior to current vaccination. Ongoing Covid 19 pandemic and co-suspect could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.