Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19 recurrent; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 recurrent) and COVID-19 (COVID-19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Overweight. Concomitant products included PRAVASTATIN for an unknown indication.   On 30-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 09-May-2022, the patient experienced COVID-19 (COVID-19). In May 2022, the patient experienced COVID-19 (COVID-19 recurrent). On 13-May-2022, COVID-19 (COVID-19) had resolved. At the time of the report, COVID-19 (COVID-19 recurrent) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: positive (Positive) Very positive test. On 13-May-2022, SARS-CoV-2 test: negative (Negative) Negative. In May 2022, Body temperature: 101 (High) 101 F. On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported have started getting COVID symptoms Sun (08-May-2022), On 09-May-2022 patient tested very positive and started Paxlovid. Symptoms were fever to 101F, cough, body aches, sinus symptoms and sneezing. Patient stated that started feeling much better within 24-48 hours and was minimally symptomatic with negative rapid test on last day of Paxlovid, Friday,13-May-2022. Within 2-3 days after Paxlovid finished started to get symptoms of reinfection: no fever, but plus body aches, cough, severe sinus and cold symptoms. It felt like a new infection as it started with nasal and sinus burning like an early cold. Symptoms  were significantly present with markedly positive rapid test on Sat, 21-May-2022, at the time of report. Company comment: This is a spontaneous case concerning a 63-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) and COVID-19(Covid-19 recurrent) which occurred 1 month 9 days after receiving the fourth dose of mRNA-1273 vaccine. The patient developed COVID symptoms on 09-May-2022 and tested very positive and started with Paxlovid treatment. Symptoms were fever to 101F, cough, body aches, sinus symptoms and sneezing, were better within 24-48 hours and was minimally symptomatic with negative rapid test on last day of Paxlovid, 13-May-2022. Within 2-3 days after completed Paxlovid started to get symptoms of body aches, cough, severe sinus cold symptoms without fever. Symptoms were significantly present with markedly positive rapid test on 21-May-2022, at the time of report. SARS-CoV-2 test was positive as on 09-May-2022 and 21-May-2022. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case concerning a 63-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) and COVID-19(Covid-19 recurrent) which occurred 1 month 9 days after receiving the fourth dose of mRNA-1273 vaccine. The patient developed COVID symptoms on 09-May-2022 and tested very positive and started with Paxlovid treatment. Symptoms were fever to 101F, cough, body aches, sinus symptoms and sneezing, were better within 24-48 hours and was minimally symptomatic with negative rapid test on last day of Paxlovid, 13-May-2022. Within 2-3 days after completed Paxlovid started to get symptoms of body aches, cough, severe sinus cold symptoms without fever. Symptoms were significantly present with markedly positive rapid test on 21-May-2022, at the time of report. SARS-CoV-2 test was positive as on 09-May-2022 and 21-May-2022. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.