Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Recurrence of symptoms of COVID with positive antigen test; Recurrence of symptoms of COVID with positive antigen test; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Recurrence of symptoms of COVID with positive antigen test) and DRUG INEFFECTIVE (Recurrence of symptoms of COVID with positive antigen test) in a 45-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 Asthma, Seasonal allergy and Depression. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) from 01-Jan-2006 to an unknown date, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 24-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient received dose of NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Recurrence of symptoms of COVID with positive antigen test) and DRUG INEFFECTIVE (Recurrence of symptoms of COVID with positive antigen test). At the time of the report, COVID-19 (Recurrence of symptoms of COVID with positive antigen test) and DRUG INEFFECTIVE (Recurrence of symptoms of COVID with positive antigen test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: positive (Positive) Recurrence of symptoms of COVID with positive antigen test. On an unknown date, 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 had allergy from unspecified past drug. It was reported that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. On 15-May-2022 at 04:00, the patient had recurrence of symptoms of COVID with positive antigen test (after taking Paxlovid which started on 04-May-2020 to 09-May-2022 for COVID treatment). No treatment information was provided by the reporter.  Company Comment: This is a spontaneous case concerning  a 45-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Covid-19 and Drug ineffective. The events occurred 201 days after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. It was reported that patient was taking Nirmatrelvir/ritonavir from  04-May-2020 to 09-May-2022., The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a 45-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Covid-19 and Drug ineffective. The events occurred 201 days after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. It was reported that patient was taking Nirmatrelvir/ritonavir from  04-May-2020 to 09-May-2022., The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.