Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Constipation, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not like the way Humira made the patient feel), COVID-19 (Tested positive for COVID-19 had been progressively getting worse) and CONSTIPATION (Constipation) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In 2022, the patient experienced COVID-19 (Tested positive for COVID-19 had been progressively getting worse). On an unknown date, the patient experienced FEELING ABNORMAL (Did not like the way Humira made the patient feel) and CONSTIPATION (Constipation). At the time of the report, FEELING ABNORMAL (Did not like the way Humira made the patient feel) and CONSTIPATION (Constipation) outcome was unknown and COVID-19 (Tested positive for COVID-19 had been progressively getting worse) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) positive. Concomitant medication was not reported. The reporters causality with respect to Humira for events COVID-19 virus test positive, constipation, COVID-19 aggravated and feeling abnormal were not reported, not reported, probable and probable respectively. Action taken for Humira with respect to event feeling abnormal was drug discontinued and de challenge was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medication was not reported. Company comment: This spontaneous case concerns a 57-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of administration of second and third dose of mRNA-1273 and onset of the event was not specified, hence latency could not be assessed. Within the current year, patient took a SARS-CoV-2 test which yielded a positive result. The patient was reported to be also taking Humira for unspecified indication, dechallenge was done with unknown results. Details of concomitant medications, medical history, clinical course and treatment were not provided. The event has not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 57-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of administration of second and third dose of mRNA-1273 and onset of the event was not specified, hence latency could not be assessed. Within the current year, patient took a SARS-CoV-2 test which yielded a positive result. The patient was reported to be also taking Humira for unspecified indication, dechallenge was done with unknown results. Details of concomitant medications, medical history, clinical course and treatment were not provided. The event has not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.