Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: lack of drug effect; test positive with faint line on rapid test; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (test positive with faint line on rapid test) and DRUG INEFFECTIVE (lack of drug effect) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient  was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Previously administered products included for Product used for unknown indication: Tetracyclene. Past adverse reactions to the above products included Allergy with Tetracyclene. Concomitant products included XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]), ATORVASTATIN and TIMOLOL for an unknown indication.   On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced BREAKTHROUGH COVID-19 (test positive with faint line on rapid test). On an unknown date, the patient experienced DRUG INEFFECTIVE (lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 09-May-2022 for COVID-19 immunisation, at an unspecified dose and frequency. At the time of the report, BREAKTHROUGH COVID-19 (test positive with faint line on rapid test) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive with faint line (Positive) Positive with faint line on rapid test. On 11-May-2022, SARS-CoV-2 test: positive with faint line (Positive) Positive with faint line on rapid test. On 12-May-2022, SARS-CoV-2 test: positive with faint line (Positive) Positive with faint line on rapid test. On 13-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative on rapid test. On 14-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative on rapid test. On 16-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative on rapid test. On 18-May-2022, SARS-CoV-2 test: positive (Positive) tested positive on rapid test.         The patient took unknown concomitant medication (which had active ingredients as Sudafed, Wal act, timolol, atorvastatin).  Completed Paxlovid doses on May 9. Continued to test positive with faint line on rapid test until May 13. Tested negative on rapid test May 13 and 14 and 16. Nasal congestion symptoms started to return May 17 and tested positive on rapid test May 18. Tested twice to be sure.  Company comment: This case concerns a 74-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 breakthrough 6 months after the third dose of mRNA-1273. Diagnosis included SARS-CoV-2 test positive, which turned negative and then positive again after treatment with nirmatrelvir, ritonavir. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 74-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 breakthrough 6 months after the third dose of mRNA-1273. Diagnosis included SARS-CoV-2 test positive, which turned negative and then positive again after treatment with nirmatrelvir, ritonavir. The benefit-risk relationship of mRNA-1273 is not affected by this report.