Age: 33.0
Sex: F
Vaccine: COVID19, 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 COVID-19 (Started paxlovid 15-Jul-2022 as advised per my OBGYN Symptoms were very mild. Sore throat and mild cough. Symptoms disappeared completely by 18-Jul-2022. Symptoms reappeared 25-Jul-2022, tested positive via an antigen at home tests on 26-Jul-2022) in a 33-year-old female 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 Blood pressure high and Allergy. Concomitant products included METFORMIN from 15-May-2022 to an unknown date and METOPROLOL from 01-Feb-2022 to an unknown date for an unknown indication. On 22-Mar-2021 at 12:00 PM, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form.   On 22-Nov-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022 at 7:00 PM, the patient experienced COVID-19 (Started paxlovid 15-Jul-2022 as advised per my OBGYN Symptoms were very mild. Sore throat and mild cough. Symptoms disappeared completely by 18-Jul-2022. Symptoms reappeared 25-Jul-2022, tested positive via an antigen at home tests on 26-Jul-2022) (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) from 15-Jul-2022 to 19-Jul-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Started paxlovid 15-Jul-2022 as advised per my OBGYN Symptoms were very mild. Sore throat and mild cough. Symptoms disappeared completely by 18-Jul-2022. Symptoms reappeared 25-Jul-2022, tested positive via an antigen at home tests on 26-Jul-2022) 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 26-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         Patient take JANSSEN COVID-19 VACCINE and patient age at that time was 32 year old. It was reported that symptoms were very mild and included Sore throat and mild cough. The symptoms disappeared completely by 18-Jul-2022 and reappeared again from 25-Jul-2022.   It was reported that patient was pregnant at the time of reported. The patient was gravida 1 and para 0. Patient last menstrual period was 02-Jun-2022 and expected delivery date was 10-Mar-2023.  Company Comment: This spontaneous case concerns a 33-year-old, female patient with no relevant medical history who experienced the unexpected, serious(medically significant) adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred approximately 8 months after receiving mRNA-1273 vaccine taken as second dose of COVID-19 vaccination series. Interchange of vaccine products and COVID-19 immunization reported as Revaccination with different COVID-19 vaccines were noted in the case as patient received Janssen COVID-19 vaccine 9 months prior to mRNA-1273 administration. Patient tested positive for COVID-19 after developing sore throat and mild cough. She consulted an obstetrician and was treated with a 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). At the time of report, COVID-19 is resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2022: Follow-up received including events added, seriousness updated. Narrative updated.; Sender's Comments: This spontaneous case concerns a 33-year-old, female patient with no relevant medical history who experienced the unexpected, serious(medically significant) adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred approximately 8 months after receiving mRNA-1273 vaccine taken as second dose of COVID-19 vaccination series. Interchange of vaccine products and COVID-19 immunization reported as Revaccination with different COVID-19 vaccines were noted in the case as patient received Janssen COVID-19 vaccine 9 months prior to mRNA-1273 administration. Patient tested positive for COVID-19 after developing sore throat and mild cough. She consulted an obstetrician and was treated with a 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). At the time of report, COVID-19 is resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.