Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Patient tested positive Covid-19 after her second dose; patient tested positive for covid on 27dec2021 3 months later after she received her second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Patient tested positive Covid-19 after her second dose) and DRUG INEFFECTIVE (patient tested positive for covid on 27dec2021 3 months later after she received her second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia since 29-Mar-2019, Hypothyroidism since 22-Oct-2019 and Type 2 diabetes mellitus since 04-Jun-2018. Concomitant products included ATORVASTATIN from 29-Mar-2019 to an unknown date, LEVOTHYROXINE from 22-Oct-2019 to an unknown date and METFORMIN from 04-Jun-2018 to an unknown date for an unknown indication.   On 23-Aug-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2021 at 1:54 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Dec-2021, the patient experienced COVID-19 (Patient tested positive Covid-19 after her second dose) and DRUG INEFFECTIVE (patient tested positive for covid on 27dec2021 3 months later after she received her second dose). At the time of the report, COVID-19 (Patient tested positive Covid-19 after her second dose) and DRUG INEFFECTIVE (patient tested positive for covid on 27dec2021 3 months later after she received her second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no allergies to medication, food and other products. Also no acute illness at time of vaccination and up to one month before. No treatment medication was reported. Patient did not consider adverse event most likely caused by Moderna vaccine. Patient consider the event did not cause the patient to seek medical case and there was no there potential causes. Patient did not experienced similar event in the past. Patient experienced mild symptoms.  Company comment: This spontaneous case concerns a 57-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI Covid-19, 98 days after the second dose of mRNA-1273. Additionally, Drug ineffective was also reported. SARS-CoV-2 antibody test was positive. At the time of reporting, the event outcome was unknown. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-503459 (Patient Link).; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI Covid-19, 98 days after the second dose of mRNA-1273. Additionally, Drug ineffective was also reported. SARS-CoV-2 antibody test was positive. At the time of reporting, the event outcome was unknown. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.