Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Lack of drug effect; patient tested positive for COVID again after Paxlovid; tested COVID-19 on 04-May-2022; This spontaneous case was reported by a physician and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (patient tested positive for COVID again after Paxlovid) and COVID-19 (tested COVID-19 on 04-May-2022) in a 67-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.    The patient's past medical history included Acid reflux (oesophageal), Thyroid disorder NOS and Irritable bowel syndrome.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose once a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced COVID-19 (tested COVID-19 on 04-May-2022). On 13-May-2022, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (patient tested positive for COVID again after Paxlovid). On 11-May-2022, COVID-19 (tested COVID-19 on 04-May-2022) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (patient tested positive for COVID again after Paxlovid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 11-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Oxygen saturation: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  as per the report Patient ethinicity was Caucasian Patient received the booster some time in the fall.  Soon as patient stopped the medication, then two days later started tested Positive for Covid-19. The patient did experience diarrhea with Paxlovid. The patient was experiencing the following symptoms congestion , sore throat, cough, and body aches . As far as patient knows these symptoms have just  persisted and patient had  diarrhea  with COVID.  Company Comment: This spontaneous case concerns a 67-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of Drug Ineffective, and adverse events of special interest, COVID-19 (2 episodes reported as "tested COVID-19 on 04-May-2022" and "patient tested positive for COVID again after Paxlovid"). The events occurred on an unknown interval (no vaccination date for the 3rd dose of mRNA-1273 vaccine) and approximately 15 months from the second dose of mRNA-1273 (with an interval of 28 days from the 1st dose). As reported, on 04-MAY-2022 patient had tested positive on COVID-19, she was then treated with Nirmatrelvir, Ritonavir (Paxlovid) in which patient felt better and tested negative 7 days later. However, 2 days later patient reported getting sick with symptoms of experiencing congestion, sore throat, cough, and body ache, SARS-CoV-2 test was positive again, no further clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of Drug Ineffective, and adverse events of special interest, COVID-19 (2 episodes reported as "tested COVID-19 on 04-May-2022" and "patient tested positive for COVID again after Paxlovid"). The events occurred on an unknown interval (no vaccination date for the 3rd dose of mRNA-1273 vaccine) and approximately 15 months from the second dose of mRNA-1273 (with an interval of 28 days from the 1st dose). As reported, on 04-MAY-2022 patient had tested positive on COVID-19, she was then treated with Nirmatrelvir, Ritonavir (Paxlovid) in which patient felt better and tested negative 7 days later. However, 2 days later patient reported getting sick with symptoms of experiencing congestion, sore throat, cough, and body ache, SARS-CoV-2 test was positive again, no further clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.