Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: Covid test Friday May 20..it was positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid test Friday May 20..it was positive) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 039k20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer, Rheumatoid arthritis and Drug allergy (Allergy to unknown drug). Concomitant products included PREDNISONE from 18-Jan-2022 to an unknown date, METHOTREXATE from 17-Feb-2022 to an unknown date and FOLIC ACID from 17-Feb-2022 to an unknown date for an unknown indication.   On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid test Friday May 20..it was positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid test Friday May 20.it was positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 100.2 100.2. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient finished the Paxlovid on Saturday morning, tested negative on Monday. The patient felt runny nose, fever 100.2, sneezing, dry cough, basically cold symptoms. No treatment medications were reported.  Company comment: This spontaneous case concerns a 77-year-old female patient, with reported medical conditions of Lung Cancer and Rheumatoid arthritis and concomitantly taking Prednisone and Methotrexate, who experienced unexpected, non-serious, AESI of COVID-19, approximately 9 months after receiving mRNA-1273 vaccine as a third dose. Dose 1 and Dose 2 of mRNA-1273 vaccine were given with a 28-day interval, approximately 6 months before receiving the third dose of mRNA-1273 vaccine. The patient was started with a course of Nirmatrelvir-Ritonavir (Paxlovid) at unspecified dose and frequency 2 days after completing the course of Paxlovid, the patient tested negative on SARS-CoV-2 test. Three days after, the patient reported runny nose, fever 100.2 (unit unknown), sneezing, dry cough, and cold symptoms. The next day, the patient tested positive on an unspecified COVID-19 test. The event was resolving. The patient's concurrent medical condition of Lung Cancer and Rheumatoid Arthritis and is on immunosuppressants (Prednisone and Methotrexate) can be considered as risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77-year-old female patient, with reported medical conditions of Lung Cancer and Rheumatoid arthritis and concomitantly taking Prednisone and Methotrexate, who experienced unexpected, non-serious, AESI of COVID-19, approximately 9 months after receiving mRNA-1273 vaccine as a third dose. Dose 1 and Dose 2 of mRNA-1273 vaccine were given with a 28-day interval, approximately 6 months before receiving the third dose of mRNA-1273 vaccine. The patient was started with a course of Nirmatrelvir-Ritonavir (Paxlovid) at unspecified dose and frequency 2 days after completing the course of Paxlovid, the patient tested negative on SARS-CoV-2 test. Three days after, the patient reported runny nose, fever 100.2 (unit unknown), sneezing, dry cough, and cold symptoms. The next day, the patient tested positive on an unspecified COVID-19 test. The event was resolving. The patient's concurrent medical condition of Lung Cancer and Rheumatoid Arthritis and is on immunosuppressants (Prednisone and Methotrexate) can be considered as risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.