Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; EXPOSED TO A COVID POSITIVE PERSON; Headache; Received second dose on 15-Jan-2021 and Booster dose on 12-Apr-2021 less than 5 month window period; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (EXPOSED TO A COVID POSITIVE PERSON), COVID-19 (COVID-19 virus test positive), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose on 15-Jan-2021 and Booster dose on 12-Apr-2021 less than 5 month window period) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 10-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose on 15-Jan-2021 and Booster dose on 12-Apr-2021 less than 5 month window period). In August 2022, the patient experienced HEADACHE (Headache). On 23-Aug-2022, the patient experienced EXPOSURE TO SARS-COV-2 (EXPOSED TO A COVID POSITIVE PERSON). On 24-Aug-2022, the patient experienced COVID-19 (COVID-19 virus test positive). At the time of the report, EXPOSURE TO SARS-COV-2 (EXPOSED TO A COVID POSITIVE PERSON), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose on 15-Jan-2021 and Booster dose on 12-Apr-2021 less than 5 month window period) outcome was unknown and COVID-19 (COVID-19 virus test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. The reporter's causality for the events of was exposed to a covid positive person/tested positive onset date 23-Aug-2022 and headache was not provided. The reporter's causality for the event of was exposed to a covid positive person/tested positive onset 24-Aug-2022 with HUMIRA(ADALIMUMAB) was no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 58-years-old female patient, with  medical history  of  Rheumatoid arthritis under treatment with ADALIMUMAB who experienced the unexpected events of Covid-19 (AESI), exposure to sars-cov-2, inappropriate schedule of product administration and other expected event 132 days after 3rd. dose of  mRNA-1273 vaccine.  On 24-Aug-2022, SARS-CoV-2 test Positive The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to MOD-2022-637436 (Patient Link).; Sender's Comments: This spontaneous case concerns a 58-years-old female patient, with  medical history  of  Rheumatoid arthritis under treatment with ADALIMUMAB who experienced the unexpected events of Covid-19 (AESI), exposure to sars-cov-2, inappropriate schedule of product administration and other expected event 132 days after 3rd. dose of  mRNA-1273 vaccine.  On 24-Aug-2022, SARS-CoV-2 test Positive The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.