Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Malaise, Pyrexia
Clinical narrative: She felt sick; She felt sick with fever; Low pressure; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (She felt sick), PYREXIA (She felt sick with fever) and DISCOMFORT (Low pressure) in a 63-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.    No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-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) 40 milligram. On an unknown date, the patient experienced MALAISE (She felt sick) (seriousness criterion hospitalization), PYREXIA (She felt sick with fever) (seriousness criterion hospitalization) and DISCOMFORT (Low pressure) (seriousness criterion hospitalization). At the time of the report, MALAISE (She felt sick), PYREXIA (She felt sick with fever) and DISCOMFORT (Low pressure) outcome was unknown.            No concomitant medication was provided. No treatment information was mentioned.  When patient took covid vaccine she felt sick with fever and was hospitalized, she had low pressure.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 63-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Rheumatoid Arthritis, who experienced the unexpected, serious (hospitalization) events of malaise (feeling sick), pyrexia and discomfort. The events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira and the event onset dates were not provided, hence, the onset latency could not be assessed. The events occurred unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that after vaccination, the patient felt sick with fever, had 'low pressure', and was hospitalized. No further clinical information (including details about hospitalization and treatment) was available for medical review. The outcomes of the events were unknown at the time of the report. The history of co-suspect administration of Humira remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Rheumatoid Arthritis, who experienced the unexpected, serious (hospitalization) events of malaise (feeling sick), pyrexia and discomfort. The events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira and the event onset dates were not provided, hence, the onset latency could not be assessed. The events occurred unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that after vaccination, the patient felt sick with fever, had 'low pressure', and was hospitalized. No further clinical information (including details about hospitalization and treatment) was available for medical review. The outcomes of the events were unknown at the time of the report. The history of co-suspect administration of Humira remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.