Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of efficacy; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Hydrocodone. Past adverse reactions to the above products included Allergy with Hydrocodone. Concurrent medical conditions included Depression, Anxiety, Obesity, Herpetic vulvovaginitis, Dyslipidemia, Thyroid nodule and Long COVID. Concomitant products included ALBUTEROL [SALBUTAMOL], MELATONIN and VITAMIN D3 for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with NIRMATRELVIR;RITONAVIR (oral) from 26-Apr-2022 to 01-May-2022 for COVID-19 treatment, at a dose of UNK dosage form. At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Two negative COVID-19 tests after finishing treatment, negative (Negative) Two negative COVID-19 tests after finishing treatment and positive (Positive) Positive test again 4 days after finishing antiviral.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had Cold/flu symptoms and were  improving after treatment. Also had side effect of diarrhea.  The Symptoms worsened again the day after finishing treatment with antiviral. Two negative COVID-19 tests after finishing treatment. Positive test again 4 days after finishing antiviral. Device Date : 31May2022 Company comment: This spontaneous case of vaccination failure concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious of COVID-19, approximately a year after the second dose of mRNA-1273 vaccine. As per source document, he received Paxlovid as COVID-19 treatment and symptoms improved after treatment. The Symptoms worsened again the day after finishing treatment with Paxlovid. He had two negative tests after finishing treatment, but retest positive 4 days later. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case of vaccination failure concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious of COVID-19, approximately a year after the second dose of mRNA-1273 vaccine. As per source document, he received Paxlovid as COVID-19 treatment and symptoms improved after treatment. The Symptoms worsened again the day after finishing treatment with Paxlovid. He had two negative tests after finishing treatment, but retest positive 4 days later. The benefit-risk relationship of mRNA-1273 is not affected by this report.