Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested Positive to COVID-19 ("Tested Positive May 11, 22. Began Paxlovid on Day 0. Completed Paxlovid on May 15 (Day 4 Texted Negative May 19 -Home test & Patients First Day 8 Tested Negative May 20-Day 9 Tested Posi"); This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested Positive to COVID-19 ("Tested Positive May 11, 22. Began Paxlovid on Day 0. Completed Paxlovid on May 15 (Day 4 Texted Negative May 19 -Home test & Patients First Day 8 Tested Negative May 20-Nomi Health Day 9 Tested Posi")) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Non-Hodgkin's lymphoma since 2012. Concomitant products included IBRUTINIB (IMBRUVICA) for an unknown indication.   On 11-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022 at 12:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested Positive to COVID-19 ("Tested Positive May 11, 22. Began Paxlovid on Day 0. Completed Paxlovid on May 15 (Day 4 Texted Negative May 19 -Home test & Patients First Day 8 Tested Negative May 20-Nomi Health Day 9 Tested Posi")). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Tested Positive to COVID-19 ("Tested Positive May 11, 22. Began Paxlovid on Day 0. Completed Paxlovid on May 15 (Day 4 Texted Negative May 19 -Home test & Patients First Day 8 Tested Negative May 20-Nomi Health Day 9 Tested Posi")) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Tested Positive 11 May 2022. Began Paxlovid on Day 0.. On 19-May-2022, SARS-CoV-2 test: negative (Negative) Texted Negative 19 May 2022 -Home test Patients First Day 8.. On 20-May-2022, SARS-CoV-2 test: negative (Negative) Tested Negative 20 May 2022-Day 9.. On 21-May-2022, SARS-CoV-2 test: positive (Positive) Tested Positive 21 May 2022- Day 10..         It was reported that patient tested positive on 11 May 2022, Began Paxlovid on Day 0. Completed Paxlovid on 15 May 2022(Day 4). Tested negative on 19 May 2022-Home test and Patients Day 8 tested negative 20 May 2022-Nomi Health Day 9 tested positive 21 May 2022-Day 10.  Company Comment: This spontaneous case concerns a 73-year-old, female patient with a long-term diagnosis of Non-Hodgkin's lymphoma on Ibrutinib (Imbruvica) therapy, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred approximately a month after receiving the second booster dose of mRNA-1273, wherein she contracted COVID-19 infection and was treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid). After completion of treatment, the patient reported testing positive in COVID-19 test after 2 negative results, which was 11 days after initial positive test. The accompanying symptoms after the positive test post-therapy and exact COVID-19 tests, whether rapid antigen or PCR, conducted were not provided in the case. The patient's immunocompromised status due to concurrent malignancy and treatment with Ibrutinib, her elderly age and the ongoing COVID-19 pandemic remain as confounders for contracting the infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old, female patient with a long-term diagnosis of Non-Hodgkin's lymphoma on Ibrutinib (Imbruvica) therapy, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred approximately a month after receiving the second booster dose of mRNA-1273, wherein she contracted COVID-19 infection and was treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid). After completion of treatment, the patient reported testing positive in COVID-19 test after 2 negative results, which was 11 days after initial positive test. The accompanying symptoms after the positive test post-therapy and exact COVID-19 tests, whether rapid antigen or PCR, conducted were not provided in the case. The patient's immunocompromised status due to concurrent malignancy and treatment with Ibrutinib, her elderly age and the ongoing COVID-19 pandemic remain as confounders for contracting the infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.