Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Paxlovid day zero thru day 4, original symptom returns day 9 and additional symptoms occur on days 10 & 11.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Paxlovid day zero thru day 4, original symptom returns day 9 and additional symptoms occur on days 10 & 11.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient did not had any other medications/products within 2 weeks of starting COVID-19 treatment.  Concurrent medical conditions included Paroxysmal atrial fibrillation, Hypercholesterolaemia (high cholesterol), Acid reflux (esophageal) (acid reflux) and Latex allergy (possibly latex skin irritation).   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 12:45 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Paxlovid day zero thru day 4, original symptom returns day 9 and additional symptoms occur on days 10 & 11.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Paxlovid day zero thru day 4, original symptom returns day 9 and additional symptoms occur on days 10 & 11.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: positive (Positive) symptom returns day 9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Patient stated that Paxlovid day zero thru day 4, original symptom returns day 9 and additional symptoms occur on days 10 & 11. Patient stated she previously received a COVID-19 Vaccine. Device Date : 02Jun2022  Company comment: This spontaneous case concerns a 78 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 1 month and 13 days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the third dose with mRNA-1273 vaccine about 5 months ago, with no reported adverse events. The patient was started on Paxlovid for COVID-19 infection from day zero though day 4.  The symptoms returned on day 9 and additional symptoms occurred on days 10 & 11. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 78 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 1 month and 13 days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the third dose with mRNA-1273 vaccine about 5 months ago, with no reported adverse events. The patient was started on Paxlovid for COVID-19 infection from day zero though day 4.  The symptoms returned on day 9 and additional symptoms occurred on days 10 & 11. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.