Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The line on the first Covid rapid test taken was faintly positive/Symptoms returned on 15-May-2022 and tested postitive; Lack of efficacy; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The line on the first Covid rapid test taken was faintly positive/Symptoms returned on 15-May-2022 and tested postitive) and DRUG INEFFECTIVE (Lack of efficacy) in a 70-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.    Patient had no drug allergies. The patient previously received a COVID-19 vaccine.  Concomitant products included LISINOPRIL, ESTROGENS ESTERIFIED, METHYLTESTOSTERONE (ESTRATEST HS) and DOXYCYCLINE for an unknown indication.   On 20-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 05-May-2022, the patient experienced COVID-19 (The line on the first Covid rapid test taken was faintly positive/Symptoms returned on 15-May-2022 and tested postitive) and DRUG INEFFECTIVE (Lack of efficacy). On 19-May-2022, COVID-19 (The line on the first Covid rapid test taken was faintly positive/Symptoms returned on 15-May-2022 and tested postitive) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, SARS-CoV-2 test: positive (Positive) The line on the first Covid-19 rapid test was faintly positive.. On 12-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 15-May-2022, SARS-CoV-2 test: positive (Positive) The positive line on the rapid test was much stronger in color than it was for the first test for Covid-19..         Concomitant medications included Lupin (Lisinopril) and Ani (Estratest HS).  The patent was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The device date was reported as 19-May-2022.  Company Comment:  This spontaneous case concerns a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with positive SARS-COV-2 test), that occurred 6 months and 6 days after receiving the third dose of mRNA-1273 vaccine.  Additionally, Drug ineffective was also included as an event. Patient had tested negative 3 days after completion of COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid).  However, patient experienced return of COVID-19 symptoms 3 days later (6 days after completion of COVID-19 treatment) and had a positive SARS-CoV-2 test. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart, which falls within the recommended dosing schedule. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with positive SARS-COV-2 test), that occurred 6 months and 6 days after receiving the third dose of mRNA-1273 vaccine.  Additionally, Drug ineffective was also included as an event. Patient had tested negative 3 days after completion of COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid).  However, patient experienced return of COVID-19 symptoms 3 days later (6 days after completion of COVID-19 treatment) and had a positive SARS-CoV-2 test. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart, which falls within the recommended dosing schedule. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.