Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID symptoms (nasal/head congestion/night sweats) almost completely gone after first 3 days of Paxlovid) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 013M20A and 011L2A) for COVID-19 vaccination. Patient had unknown drug allergy. Concurrent medical conditions included Hypertension and Hyperlipidemia. Concomitant products included HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ), VITAMIN D3, BUPROPION, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), SIMVASTATIN and FAMOTIDINE for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (COVID symptoms (nasal/head congestion/night sweats) almost completely gone after first 3 days of Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 27-Apr-2022 to 01-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID symptoms (nasal/head congestion/night sweats) almost completely gone after first 3 days of Paxlovid) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient took unknown other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Patient had Rebound COVID symptoms (nasal/head congestion/night sweats) almost completely gone after first 3 days of Paxlovid. Company comment: This spontaneous case concerns a 54-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 27-April-2022 to 01-may-2022. It reported that Covid symptoms (nasal/head congestion/night sweats) completely gone after 3 days of Paxlovid. Approximately 4 days after completing the Paxlovid, symptoms came back lasting around 7 days. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 54-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 27-April-2022 to 01-May-2022. It reported that Covid symptoms (nasal/head congestion/night sweats) completely gone after 3 days of Paxlovid. Approximately 4 days after completing the Paxlovid, symptoms came back lasting around 7 days. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.