Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid symptoms returned three days after I tested; Covid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid symptoms) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083F23A, 036A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Patient had no allergy.  Concurrent medical conditions included Blood pressure high and High cholesterol.   On 05-Feb-2021 at 3:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 17-Apr-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid symptoms) (seriousness criterion medically significant). On an unknown date, the patient experienced DRUG INEFFECTIVE (Covid symptoms returned three days after I tested). The patient was treated with AZITHROMYCIN on 30-Apr-2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid symptoms) had resolved and DRUG INEFFECTIVE (Covid symptoms returned three days after I tested) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  It was reported that the patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment.  COVID symptoms returned three days after she tested negative, eight days after she completed Paxlovid.  The patient had previously received a COVID-19 Vaccine. Company Comment: This spontaneous case concerns a 76 year old  female patient  with relevant  medical history  of hypertension  and high cholesterol , who experienced serious ( Medically significant ) , unexpected  , ADR  of Covid 19 which occurred  One year,  one month  and 14 days   post -vaccination with the 2nd dose of mRNA-1273 vaccine. The dose 1 and dose 3  Covid 19 vaccine of this patient were also mRNA-1273 vaccine.  Event of Drug ineffective  was also reported for this case. The signs and symptoms of the Covid 19 of this patient was not reported . She was treated with  NIRMATRELVIR, RITONAVIR (Paxlovid ) with unspecified dose and frequency  ( a non-company oral anti-viral treatment for Covid 19) course of treatment completed .  However   COVID symptoms returned three days after she tested negative, eight days after she completed Paxlovid. She was given Azithromycin on April 30, 2022.   Outcome of the events was reported as resolved. The age of this patient , the above mentioned medical conditions are considered as confounders for the events. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76 year old  female patient  with relevant  medical history  of hypertension  and high cholesterol , who experienced serious ( Medically significant ) , unexpected  , AESI  of Covid 19 which occurred  One year,  one month  and 14 days   post -vaccination with the 2nd dose of mRNA-1273 vaccine. The dose 1 and dose 3  Covid 19 vaccine of this patient were also mRNA-1273 vaccine.  Event of Drug ineffective  was also reported for this case. The signs and symptoms of the Covid 19 of this patient was not reported . She was treated with  NIRMATRELVIR, RITONAVIR (Paxlovid ) with unspecified dose and frequency  ( a non-company oral anti-viral treatment for Covid 19) course of treatment completed .  However   COVID symptoms returned three days after she tested negative, eight days after she completed Paxlovid. She was given Azithromycin on April 30, 2022.   Outcome of the events was reported as resolved. The age of this patient , the above mentioned medical conditions are considered as confounders for the events. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.