Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Paxlovid rebound. Patient tested positive for COVID via PCR 5/10; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Paxlovid rebound. Patient tested positive for COVID via PCR 5/10) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Psoriatic arthritis, Hashimoto's thyroiditis, Drug allergy, Drug allergy and Penicillin allergy. Concomitant products included ESTRADIOL from 30-Jun-2021 to an unknown date, MEDROXYPROGESTERONE (PROVERA [MEDROXYPROGESTERONE]) from 06-Apr-2022 to an unknown date and PHENTERMINE from 25-Apr-2022 to an unknown date for an unknown indication.   On 19-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 05-May-2022, the patient experienced COVID-19 (Paxlovid rebound. Patient tested positive for COVID via PCR 5/10). At the time of the report, COVID-19 (Paxlovid rebound. Patient tested positive for COVID via PCR 5/10) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 28-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.   On 23-May-2022, COVID symptoms returned. The patient was on antibiotics from 23-May-2022 to 28-May-2022 with no improvement. Isolation was continued and the patient was given OTC medications.  Company comment: This spontaneous case concerns a 36 years female, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 52 days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-may-2022 to 15-may-2022.Patient.After 8 days of paxlovid symptom started,patient is on antibiotic no improvement, She was tested positive 13 days after the treatment with Paxlovid. 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 36 years female, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 52 days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-may-2022 to 15-may-2022.Patient.After 8 days of paxlovid symptom started,patient is on antibiotic no improvement, She was tested positive 13 days after the treatment with Paxlovid. 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.