Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: I got a Fever; I had COVID in April and then again in May. I took Paxlovid and the day after I finished I got afever and became sicker than I was initially. The throat, the horrible cold and incredible fatigue set in. On day 10 I tested Neg but am VERY VERY TIRED/T; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had COVID in April and then again in May. I took Paxlovid and the day after I finished I got afever and became sicker than I was initially. The throat, the horrible cold and incredible fatigue set in. On day 10 I tested Neg but am VERY VERY TIRED/T) and PYREXIA (I got a Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included COVID-19 in April 2022. Concurrent medical conditions included Allergy (No product was reported.).   On 08-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022, the patient experienced COVID-19 (I had COVID in April and then again in May. I took Paxlovid and the day after I finished I got afever and became sicker than I was initially. The throat, the horrible cold and incredible fatigue set in. On day 10 I tested Neg but am VERY VERY TIRED/T). On an unknown date, the patient experienced PYREXIA (I got a Fever). At the time of the report, COVID-19 (I had COVID in April and then again in May. I took Paxlovid and the day after I finished I got afever and became sicker than I was initially. The throat, the horrible cold and incredible fatigue set in. On day 10 I tested Neg but am VERY VERY TIRED/T) was resolving and PYREXIA (I got a Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The onset time of 3rd dose of Moderna Vaccine was reported as 03:00 PM. The patient had not received any other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 63-year-old female patient, with co-suspect product Paxlovid, who experienced the unexpected  of COVID-19. The event occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine (Primary doses - Moderna). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however one day after completing treatment, the patient started having oropharyngeal discomfort, nasopharyngitis and fatigue, and tested positive again for COVID-19. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 63-year-old female patient, with co-suspect product Paxlovid, who experienced the unexpected of COVID-19. The event occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine (Primary doses - Moderna). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however one day after completing treatment, the patient started having oropharyngeal discomfort, nasopharyngitis and fatigue, and tested positive again for COVID-19. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.