Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: Covid symptoms returned on May 13, 2022 including congestion, sneezing, runny nose and fatigue.; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid symptoms returned on May 13, 2022 including congestion, sneezing, runny nose and fatigue.) and DRUG INEFFECTIVE (Lack of efficacy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 024M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and High cholesterol. Concomitant products included LOSARTAN and EZETIMIBE from an unknown date to 03-May-2022 for an unknown indication.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid symptoms returned on May 13, 2022 including congestion, sneezing, runny nose and fatigue.) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 07-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid symptoms returned on May 13, 2022 including congestion, sneezing, runny nose and fatigue.) had not resolved and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, Blood pressure measurement: 187/67 (High) 187/67.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included unspecified medication for blood pressure and high cholesterol. On an unknown date, patient started with Rovastatin and stopped on 03-May-2022.  Patient's Covid symptoms returned on 13-May-2022, which included congestion, sneezing, runny nose and fatigue.  No treatment medications were provided.  Company comment- This spontaneous case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred at an unknown time with regards to the mRNA-1273 vaccination. Additionally, Drug ineffective was also reported.  Patient noted an elevated blood pressure 6 months and 3 weeks after vaccination with a third dose of mRNA-1273. 3 days after, she noted return of covid symptoms such as congestion, sneezing, runny nose and fatigue. Outcome of the events was not resolved at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred at an unknown time with regards to the mRNA-1273 vaccination. Additionally, Drug ineffective was also reported.  Patient noted an elevated blood pressure 6 months and 3 weeks after vaccination with a third dose of mRNA-1273. 3 days after, she noted return of covid symptoms such as congestion, sneezing, runny nose and fatigue. Outcome of the events was not resolved at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.