Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Recurrent Covid symptoms very similar to the previous ones onset 5 days after completing full course of Paxlovid and with a positive home antigen test the next day (6 days from finishing Paxlovid).; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Recurrent Covid symptoms very similar to the previous ones onset 5 days after completing full course of Paxlovid and with a positive home antigen test the next day (6 days from finishing Paxlovid).) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 016B21A and 039905) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Osteoporosis and Drug allergy (The patient had allergy to unknown past drug). Concomitant products included HYDROCHLOROTHIAZIDE from May 2020 to an unknown date, VITAMIN B12 NOS from January 2018 to an unknown date, VITAMIN D NOS from January 2012 to an unknown date, CALCIUM from January 2012 to an unknown date and VITAMIN B COMPLEX from January 2021 to an unknown date for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022 at 9:30 AM, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 09-May-2022 at 9:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Recurrent Covid symptoms very similar to the previous ones onset 5 days after completing full course of Paxlovid and with a positive home antigen test the next day (6 days from finishing Paxlovid).). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Recurrent Covid symptoms very similar to the previous ones onset 5 days after completing full course of Paxlovid and with a positive home antigen test the next day (6 days from finishing Paxlovid).) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Reporter reported that recurrent Covid-19 symptoms appeared five days after completing full course of Paxlovid with a positive home antigen test the next day. Both initial and recurrent symptoms had been mild and still persist. The symptoms included, sore throat, congestion, rhinorrhea, myalgias, headache, fatigue and poor appetite. It was also reported that the initial symptoms had started on 9-May-2022 with positive antigen test and diagnosis of COVID on 10-May-22 which seemingly resolved by about 19-May-2022. Did not repeat antigen test at that time. However symptoms had recurred two days later. COMPANY COMMENT: This is an spontaneous case concerning a 66-years-old female patient with medical history of Osteoporosis and Drug allergy, Concomitant products included HYDROCHLOROTHIAZIDE, VITAMIN B12, VITAMIN D, CALCIUM, VITAMIN B COMPLEX, received dose of mRNA-1273 on 24-Feb, 24-Mar and 02-Nov-2021, on 13-Apr-2022 received fourth dose of TOZINAMERAN COVID-19 vaccine, PAXLOVID from 11-May-2022 to 16-May-2022 for COVID-19 treatment who experienced the unexpected AESI event of COVID-19  (seriousness criterion medically significant) 159 days after  3rd  dose of  mRNA-1273 vaccine. On 10-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 66-years-old female patient with medical history of Osteoporosis and Drug allergy, Concomitant products included HYDROCHLOROTHIAZIDE, VITAMIN B12, VITAMIN D, CALCIUM, VITAMIN B COMPLEX, received dose of mRNA-1273 on 24-Feb, 24-Mar and 02-Nov-2021, on 13-Apr-2022 received fourth dose of TOZINAMERAN COVID-19 vaccine, PAXLOVID from 11-May-2022 to 16-May-2022 for COVID-19 treatment who experienced the unexpected AESI event of COVID-19  (seriousness criterion medically significant) 159 days after  3rd  dose of  mRNA-1273 vaccine. On 10-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.