Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: "Finished Paxlovid on 29May2022. Tested negative on 01Jun2022. Symptoms returned 03Jun2022. Tested positive on 04Jun2022. All tests were rapid antigen tests.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 ("Finished Paxlovid on 29May2022. Tested negative on 01Jun2022. Symptoms returned 03Jun2022. Tested positive on 04Jun2022. All tests were rapid antigen tests.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 028A21A and 048F21A) for an unknown indication.     The patient's past medical history included Prostate cancer (prostate cancer in 2012) in 2012. Concurrent medical conditions included Hypothyroidism and Drug allergy (Drug name not reported). Concomitant products included LEVOTHYROXINE, TAMSULOSIN, TADALAFIL, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRINE), MAGNESIUM and COLECALCIFEROL (D3) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 ("Finished Paxlovid on 29May2022. Tested negative on 01Jun2022. Symptoms returned 03Jun2022. Tested positive on 04Jun2022. All tests were rapid antigen tests.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 ("Finished Paxlovid on 29May2022. Tested negative on 01Jun2022. Symptoms returned 03Jun2022. Tested positive on 04Jun2022. All tests were rapid antigen tests.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2022, SARS-CoV-2 test: negative (Negative) Negative, Rapid antigen test. On 04-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive, Rapid antigen test.         It was reported that patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had previously received a COVID-19 Vaccine. It was reported that the patient had finished Paxlovid on 29-May-2022. Tested negative on 01-Jun-2022. Symptoms returned on 03-Jun-2022. Tested positive on 04-Jun-2022. All tests were rapid antigen tests with Device Date a 04-Jun-2022.  Company Comment: This spontaneous case concerns a 73-year-old, male patient with relevant medical history of prostate cancer (unknown status) and concomitant use of Atorvastatin and Aspirin for unknown indications, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The infection occurred approximately 7 months after receiving mRNA-1273 as primary COVID-19 vaccine series and booster dose, wherein he was treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid). The patient recovered and tested negative, using rapid antigen test, after treatment. However, 2 days after the initial negative, the patient noted recurrence of unspecified symptoms. He then underwent another rapid antigen test which revealed a positive result. Clinical course during recurrence of symptoms and treatment administered after were not provided in the case. The patient's elderly age and history of prostate cancer remain as risk factors to contracting the infection. Additionally, intake of Atorvastatin and Aspirin could be suggestive of a high cardiovascular risk which may also have increased the patient's susceptibility to the COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old, male patient with relevant medical history of prostate cancer (unknown status) and concomitant use of Atorvastatin and Aspirin for unknown indications, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The infection occurred approximately 7 months after receiving mRNA-1273 as primary COVID-19 vaccine series and booster dose, wherein he was treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid). The patient recovered and tested negative, using rapid antigen test, after treatment. However, 2 days after the initial negative, the patient noted recurrence of unspecified symptoms. He then underwent another rapid antigen test which revealed a positive result. Clinical course during recurrence of symptoms and treatment administered after were not provided in the case. The patient's elderly age and history of prostate cancer remain as risk factors to contracting the infection. Additionally, intake of Atorvastatin and Aspirin could be suggestive of a high cardiovascular risk which may also have increased the patient's susceptibility to the COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.