Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Probably rebound case of COVID after finishing PAXLOVID; Initial positive COVID test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial positive COVID test) and COVID-19 (Probably rebound case of COVID after finishing PAXLOVID) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.  Concurrent medical conditions included Metastatic breast cancer and Drug allergy. Concomitant products included ALPELISIB (PIQRAY) from 13-Apr-2021 to an unknown date, ESCITALOPRAM OXALATE (LEXAPRO), GABAPENTIN and OMEPRAZOLE for an unknown indication.  On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced COVID-19 (Initial positive COVID test). On 31-May-2022, the patient experienced COVID-19 (Probably rebound case of COVID after finishing PAXLOVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Initial positive COVID test) and COVID-19 (Probably rebound case of COVID after finishing PAXLOVID) was resolving.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive.  It was reported that the patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. Patient probably had rebound case of COVID after finishing PAXLOVID. Initial positive COVID test on May 12, took PAXLOID May 14 - 18. The symptoms were improved. Again tested positive on 31-May-2022. The awareness date was reported as 31-May-2022.  Company comment: This spontaneous case concerns a 44-year-old, female patient with relevant medical history of Metastatic Breast cancer, who experienced the unexpected, non-serious AESI of COVID-19 (LLT: COVID-19) and COVID-19 (LLT: COVID-19 recurrent). The event COVID-19 (LLT: COVID-19) occurred approximately 7 months after receiving the third dose of the mRNA-1273 vaccine. The event COVID-19 (LLT: COVID-19 recurrent) occurred approximately 8 months after receiving the third dose of the mRNA-1273 vaccine. The patient initially tested positive for SARS-CoV-2 on 12May2022. No symptoms were reported. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 14May2022 to 18May2022. It was reported that the symptoms (unspecified) had improved. However, the patient again tested positive for SARS-CoV-2 13 days after treatment with Paxlovid. No treatment was provided for the event COVID-19 recurrent. The medical history of Metastatic Breast cancer, which is a known risk factor for COVID-19, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old, female patient with relevant medical history of Metastatic Breast cancer, who experienced the unexpected, non-serious AESI of COVID-19 (LLT: COVID-19) and COVID-19 (LLT: COVID-19 recurrent). The event COVID-19 (LLT: COVID-19) occurred approximately 7 months after receiving the third dose of the mRNA-1273 vaccine. The event COVID-19 (LLT: COVID-19 recurrent) occurred approximately 8 months after receiving the third dose of the mRNA-1273 vaccine. The patient initially tested positive for SARS-CoV-2 on 12May2022. No symptoms were reported. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 14May2022 to 18May2022. It was reported that the symptoms (unspecified) had improved. However, the patient again tested positive for SARS-CoV-2 13 days after treatment with Paxlovid. No treatment was provided for the event COVID-19 recurrent. The medical history of Metastatic Breast cancer, which is a known risk factor for COVID-19, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.