Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Onychomycosis, Pancreatitis, Stress, Uveitis
Clinical narrative: Pancreatitis; Autoimmune Disorder; Uveitis flare up; Crohn's aggravated; Chest heaviness; Stress; Blood pressure high; Cluster headaches; Fungal infection of nail; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (Pancreatitis), AUTOIMMUNE DISORDER (Autoimmune Disorder), UVEITIS (Uveitis flare up) and CROHN'S DISEASE (Crohn's aggravated) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication.    Concomitant products included COVID-19 VACCINE for COVID-19 vaccination.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 01-Dec-2021, the patient experienced CLUSTER HEADACHE (Cluster headaches), ONYCHOMYCOSIS (Fungal infection of nail) and HYPERTENSION (Blood pressure high). On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), AUTOIMMUNE DISORDER (Autoimmune Disorder) (seriousness criterion medically significant), UVEITIS (Uveitis flare up) (seriousness criterion medically significant), CROHN'S DISEASE (Crohn's aggravated) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest heaviness) and STRESS (Stress). At the time of the report, PANCREATITIS (Pancreatitis), AUTOIMMUNE DISORDER (Autoimmune Disorder), UVEITIS (Uveitis flare up), CROHN'S DISEASE (Crohn's aggravated), CHEST DISCOMFORT (Chest heaviness) and STRESS (Stress) had not resolved and CLUSTER HEADACHE (Cluster headaches), ONYCHOMYCOSIS (Fungal infection of nail) and HYPERTENSION (Blood pressure high) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. Intramuscular COVID-19 Vaccine was administered as concomitant.  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 59  year  old, female patient, in treatment with Ibrutinib (unknown indication), who received a dose of mRNA  1273 vaccine and experienced the unexpected, serious medically significant events of pancreatitis (AESI), autoimmune disorder, uveitis (described as "uveitis flare up") and Crohn´s disease (described as "Crohn´s flare up"). Vaccination date and onset date of the events were not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient was under lot of stress and had an autoimmune reaction which caused a uveitis flare up, Crohn´s flare up and pancreatitis. No further details were provided for medical reviewing. Co  suspect product Ibrutinib remains as confounder. Pancreatitis and uveitis could be related to Crohn´s disease (flaring of symptoms is part of the natural course of Crohn´s disease; however, no medical history was provided). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow up received by safety on 18-Apr-2022 has Email and contains Significant information- Events updated.; Sender's Comments: This spontaneous case concerns a 59  year  old, female patient, in treatment with Ibrutinib (unknown indication), who received a dose of mRNA  1273 vaccine and experienced the unexpected, serious medically significant events of pancreatitis (AESI), autoimmune disorder, uveitis (described as "uveitis flare up") and Crohn´s disease (described as "Crohn´s flare up"). Vaccination date and onset date of the events were not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient was under lot of stress and had an autoimmune reaction which caused a uveitis flare up, Crohn´s flare up and pancreatitis. No further details were provided for medical reviewing. Co  suspect product Ibrutinib remains as confounder. Pancreatitis and uveitis could be related to Crohn´s disease (flaring of symptoms is part of the natural course of Crohn´s disease; however, no medical history was provided). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.