Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive again for COVID on 5/17/22, so I had a rebound COVID infection.) and DRUG INEFFECTIVE (Lack of drug effect) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 025J20-2A) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis, Penicillin allergy and Allergy to antibiotic (levaquin allergy). Concomitant products included UPADACITINIB (RINVOQ) from an unknown date to 04-May-2022 and METHOTREXATE from 26-Jan-2019 to 07-May-2022 for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 16-May-2022, the patient experienced COVID-19 (Tested positive again for COVID on 5/17/22, so I had a rebound COVID infection.) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive again for COVID on 5/17/22, so I had a rebound COVID infection.) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 17-May-2022, SARS-CoV-2 test: positive (Positive) tested positive again for COVID. It was reported that the patient recovered from COVID-19 after completing the Paxlovid on 12-May-2022. Patient had several negative rapid tests. Symptoms returned on 16-May-2022 and tested positive again for COVID-19 on 17-May-2022, so patient had a rebound COVID infection. Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: Yes. Did you/the patient previously receive a COVID-19 Vaccine: Yes. Treatment received was unknown. Company Comment: This is a spontaneous case concerning a 40-year-old female patient with reported medical history of Rheumatoid Arthritis with concomitant medication of Methotrexate and Upadacitinib, who experienced the unexpected non serious events of Drug Ineffective, and adverse event of special interest, COVID-19 which occurred approximately 9 months after receiving the 3rd dose of mRNA-1273 Vaccine with an interval of 6 months from the 2nd dose of mRNA-1273 vaccine and with an interval of 28 days from the 1st dose of mRNA-1273 vaccine. The events also occurred 9 days after receiving the co-suspect, non-company product Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 vaccination. It was reported that the patient recovered from COVID-19 after completing treatment Paxlovid on 12-May-2022 and had several negative rapid tests however symptoms returned on 16-May-2022 and tested positive again for COVID-19 on 17-May-2022, so patient had a rebound COVID infection. No other clinical or treatment details were given. The medical history of Rheumatoid Arthritis with concomitant medication of Methotrexate and Upadacitinib 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 40-year-old female patient with reported medical history of Rheumatoid Arthritis with concomitant medication of Methotrexate and Upadacitinib, who experienced the unexpected non serious events of Drug Ineffective, and adverse event of special interest, COVID-19 which occurred approximately 9 months after receiving the 3rd dose of mRNA-1273 Vaccine with an interval of 6 months from the 2nd dose of mRNA-1273 vaccine and with an interval of 28 days from the 1st dose of mRNA-1273 vaccine. The events also occurred 9 days after receiving the co-suspect, non-company product Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 vaccination. It was reported that the patient recovered from COVID-19 after completing treatment Paxlovid on 12-May-2022 and had several negative rapid tests however symptoms returned on 16-May-2022 and tested positive again for COVID-19 on 17-May-2022, so patient had a rebound COVID infection. No other clinical or treatment details were given. The medical history of Rheumatoid Arthritis with concomitant medication of Methotrexate and Upadacitinib remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.