Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: HOSPITALIZATION; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (HOSPITALIZATION) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HOSPITALISATION (HOSPITALIZATION) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to HOSPITALISATION. At the time of the report, HOSPITALISATION (HOSPITALIZATION) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  Reportedly, patient was hospitalized while taking Humira. She was in the hospital for five days and then six weeks in nursing hospital.  The reporter's causality for the event(s) of HOSPITALIZATION with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment information was provided.  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 an elderly, female patient with history of co-suspect administration of Humira (adalimumab) for unknown indication, who experienced the unexpected, serious event of hospitalisation. The event occurred unknown number of days after receiving Humira and unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the administration dates of Humira and the mRNA-1273 vaccine were not reported while the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient was hospitalized while receiving Humira. She was in the hospital for 5 days and then 6 weeks in the nursing hospital. No further clinical information (including symptoms, details about hospitalization, laboratory test/s and treatment) was available for medical review. The 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 an elderly, female patient with history of co-suspect administration of Humira (adalimumab) for unknown indication, who experienced the unexpected, serious event of hospitalisation. The event occurred unknown number of days after receiving Humira and unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the administration dates of Humira and the mRNA-1273 vaccine were not reported while the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient was hospitalized while receiving Humira. She was in the hospital for 5 days and then 6 weeks in the nursing hospital. No further clinical information (including symptoms, details about hospitalization, laboratory test/s and treatment) was available for medical review. The co-suspect administration of Humira remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.