Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received second dose on: 24Feb2021, Diagnosed with COVID19 on 29Oct2021; COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION FAILURE (Received second dose on: 24Feb2021, Diagnosed with COVID19 on 29Oct2021) and COVID-19 (COVID-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia. Concomitant products included SOTALOL and APIXABAN (ELIQUIS) for Arrhythmia, LEVOTHYROXINE, VITAMIN D [VITAMIN D NOS] and FOLIC ACID (FOLATE) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION FAILURE (Received second dose on: 24Feb2021, Diagnosed with COVID19 on 29Oct2021) and COVID-19 (COVID-19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in October 2021 at an unspecified dose and frequency and PHENYLEPHRINE HYDROCHLORIDE (EPHRINE [PHENYLEPHRINE HYDROCHLORIDE]) in October 2021 at a dose of UNK UNK, as necessary. At the time of the report, VACCINATION FAILURE (Received second dose on: 24Feb2021, Diagnosed with COVID19 on 29Oct2021) outcome was unknown and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Medication also included monoclonal antibody from Regeneron. It was considered a case of mild COVID19 but was given monoclonal antibody from Regeneron. The patient did not require hospitalization. The patient was not well for a couple of days and flu like symptoms persisted for weeks. The patient only feels perfectly fine today 21-Nov-2021.  This is a spontaneous case concerning a 72-year-old, female patient with no relevant medical history, who experienced the unexpected, non serious, AESI event of Covid-19 and unexpected, non serious event of vaccination failure. The patient received mRNA-1273 vaccine for dose 1 and dose 2 with appropriate dosage interval of 28 days. The events Covid-19 and vaccination failure occurred 247 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old, female patient with no relevant medical history, who experienced the unexpected, non serious, AESI event of Covid-19 and unexpected, non serious event of vaccination failure. The patient received mRNA-1273 vaccine for dose 1 and dose 2 with appropriate dosage interval of 28 days. The events Covid-19 and vaccination failure occurred 247 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.