Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19 prior to Paxlovid treatment) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Depression, Seasonal allergy, Overweight and Allergy NOS. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), MULTIVITAMINS [VITAMINS NOS], VITAMIN D NOS and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency; PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19 prior to Paxlovid treatment) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Tested negative for three days and positive (Positive) tested positive for 5 additional day.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that patient was isolation for 5 more days.  Pfizer have permission to contact about this report but does not have permission to contact the patient's healthcare provider. The device date was reported as 31-May-2022  Company Comment: This spontaneous case concerns a 38-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 18 th to 22 nd May-2022 and tested negative three days after Paxlovid, however tested positive 5 days later with symptoms of congestion and headache. 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 38-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI  of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 18 th to 22 nd May-2022 and tested negative three days after Paxlovid, however tested positive 5 days later with symptoms of congestion and headache. 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.