Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On day 9 I also tested positive on a rapid test; On day 6 after starting Paxlovid, I felt much better and tested negative on a rapid test/also tested positive on PCR test on day 1 and 7; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (On day 9 I also tested positive on a rapid test), COVID-19 (On day 6 after starting Paxlovid, I felt much better and tested negative on a rapid test/also tested positive on PCR test on day 1 and 7) and DRUG INEFFECTIVE (Lack of drug effect) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 007B21A and 015M20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hypertension and Type II diabetes mellitus. Concomitant products included SIMVASTATIN from 01-Oct-2021 to 06-May-2022, LOSARTAN POTASSIUM from 01-Jan-2020 to an unknown date, METFORMIN from 01-Jan-2020 to an unknown date, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 01-Jan-2020 to an unknown date, SEMAGLUTIDE (OZEMPIC) from 01-Jan-2020 to an unknown date, PANTOPRAZOLE from 01-Jan-2021 to an unknown date, BIFIDOBACTERIUM INFANTIS (ALIGN) from 01-Jan-2021 to an unknown date and CENTRUM SELECT 50+ for an unknown indication.   On 24-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-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 31-Oct-2021 at 7:00 PM, 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. In May 2022, the patient experienced COVID-19 (On day 6 after starting Paxlovid, I felt much better and tested negative on a rapid test/also tested positive on PCR test on day 1 and 7) and DRUG INEFFECTIVE (Lack of drug effect). On 15-May-2022 at 1:00 PM, the patient experienced COVID-19 (On day 9 I also tested positive on a rapid test). In May 2022, COVID-19 (On day 6 after starting Paxlovid, I felt much better and tested negative on a rapid test/also tested positive on PCR test on day 1 and 7) had resolved. At the time of the report, COVID-19 (On day 9 I also tested positive on a rapid test) was resolving 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) On day 6 tested  Negative, positive (Positive) on day 1 tested positive PCR, positive (Positive) on day 7 tested positive PCR and. On 15-May-2022, SARS-CoV-2 test positive (Positive) On day 9 tested very dark positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported on day 6 after starting Paxlovid he felt much better tested negative on a rapid test. On day 9 he started feeling severe nasal congestion and exhaustion which continued on day 10 and then much better on day 10. On day 9 patient also tested positive on a rapid test, very quick and very dark positive. Patient also tested positive on PCR test on day 1 and 7  Device date was reported 17-May-2022 Company comment: This spontaneous case concerns a 62-year-old male patient with medical history of Diabetes Mellitus II and Hypertension, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (reported as COVID-19 and COVID-19 recurrent). Additionally, Drug ineffective was also reported. The event COVID-19 (reported as COVID-19) occurred 196 days after administration of third dose of mRNA-1273, the initial two doses of mRNA-1273 were given approximately 7 months prior, the interval between the two doses is 28 days. The exact date of onset of the event COVID-19 (reported as COVID-19 recurrent) was not specified in respect to administration of a dose of mRNA-1273, hence latency could not be assessed. On May 15, 2022, patient took a SARS-CoV-2 which turned a positive result. The patient started Paxlovid 8 days prior to the event, it has been reported that on day 6 of treatment, symptoms have resolved and had a negative SARS-CoV-2 test but on day 9 of treatment, he had nasal congestion and exhaustion he took a SARS-CoV-2 test and revealed a positive result. The patient's medical history of Diabetes Mellitus II and Hypertension could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old male patient with medical history of Diabetes Mellitus II and Hypertension, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (reported as COVID-19 and COVID-19 recurrent). Additionally, Drug ineffective was also reported. The event COVID-19 (reported as COVID-19) occurred 196 days after administration of third dose of mRNA-1273, the initial two doses of mRNA-1273 were given approximately 7 months prior, the interval between the two doses is 28 days. The exact date of onset of the event COVID-19 (reported as COVID-19 recurrent) was not specified in respect to administration of a dose of mRNA-1273, hence latency could not be assessed. On May 15, 2022, patient took a SARS-CoV-2 which turned a positive result. The patient started Paxlovid 8 days prior to the event, it has been reported that on day 6 of treatment, symptoms have resolved and had a negative SARS-CoV-2 test but on day 9 of treatment, he had nasal congestion and exhaustion he took a SARS-CoV-2 test and revealed a positive result. The patient's medical history of Diabetes Mellitus II and Hypertension could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.