Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: was not feeling so great took the rapid test twice which both resulted positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (was not feeling so great took the rapid test twice which both resulted positive) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: JANSSEN COVID-19 VACCINE (batch number 1808980) and JANSSEN COVID-19 VACCINE (batch number 1808980). Past adverse reactions to the above products included Suspected COVID-19 with JANSSEN COVID-19 VACCINE; and Vaccination failure with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Heart disease, unspecified.    In December 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (was not feeling so great took the rapid test twice which both resulted positive). At the time of the report, COVID-19 (was not feeling so great took the rapid test twice which both resulted positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 29 Dec 2021, the patient had COVID symptoms and started feeling better. By 01 Jan 2022 was not feeling so great but not terrible, so the patient took the rapid test twice which both resulted positive experienced suspected covid-19 infection, and suspected clinical vaccination failure and the doctor started giving Paxlovid antiviral which the reporter took for three days and had some side effects that were not extreme like nausea. Overall patient was not feeling good. The patient also experienced suspected COVID-19 infection, and suspected clinical vaccination failure.  Company comment: This Spontaneous case concerns a 74-year-old, patient of unknown gender, with medical history heart disease unspecified, who experienced the unexpected, non-serious and AESI of COVID-19. Time to onset from vaccination with a dose of of mRNA-1273 vaccine, considered as the second dose of the patient's COVID-19 vaccination schedule, was not reported, as event and vaccination dates are not available. The patient reported that was not feeling well, hence took two rapid test that resulted positive on January 1st 2022. It was reported that the patient received previously as first dose a dose of Janssen's COVID-19 vaccine. The medical history heart disease unspecified remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Reporter's Comments: VO: 20220123706-?ovid-19 vaccine ad26.cov2.9- Suspected clinical vaccination failure. This event (s) is considered not related. The event (s) has a compatible/ suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event (8) than the drug. Specifically: SPECIAL SITUATIONS.; Sender's Comments: This Spontaneous case concerns a 74-year-old, patient of unknown gender, with medical history heart disease unspecified, who experienced the unexpected, non-serious and AESI of COVID-19. Time to onset from vaccination with a dose of of mRNA-1273 vaccine, considered as the second dose of the patient's COVID-19 vaccination schedule, was not reported, as event and vaccination dates are not available. The patient reported that was not feeling well, hence took two rapid test that resulted positive on January 1st 2022. It was reported that the patient received previously as first dose a dose of Janssen's COVID-19 vaccine. The medical history heart disease unspecified remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.