Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Pancreatitis, Vaccine positive rechallenge
Clinical narrative: Diagnosed with pancreatitis 4 days after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (Diagnosed with pancreatitis 4 days after second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084M20A, 013L20A and 002F21A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised. Concurrent medical conditions included Headache. Concomitant products included AMITRIPTYLINE for Headache, BUPROPION HYDROCHLORIDE (WELLBUTRIN), SERTRALINE HYDROCHLORIDE (ZOLOFT), FOLIC ACID, VITAMIN D3, DENOSUMAB (PROLIA) and RITUXIMAB (RITUXAN) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PANCREATITIS (Diagnosed with pancreatitis 4 days after second dose) (seriousness criterion medically significant). At the time of the report, PANCREATITIS (Diagnosed with pancreatitis 4 days after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: diagnosed with pancreatitis (abnormal) diagnosed with pancreatitis.         Patient was advice to take the third dose by their rheumatologist because she was immunocompromised. Four days after the second dose patient was diagnosed with pancreatitis and this was confirmed by blood work. Treatment drugs included pain medications and nausea medications.  Company Comment: This is a Spontaneous case concerning a 71-year-old, female patient with medical history of immunocompromised, who experienced the unexpected serious AESI of Pancreatitis. The event occurred approximately 4 days after the second dose of mRNA 1273 vaccine. The re-challenge is positive since the patient experienced Pancreatitis 3 days after the first dose and also 2 days after the third dose of the mRNA 1273 vaccine (confirmed by blood workup).  The medical history of immunocompromised is a confounder for the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395624, MOD-2021-395647 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Added lab data, dosage detail of vaccine, concomitant medications, treatment medication.; Sender's Comments: This is a Spontaneous case concerning a 71-year-old, female patient with medical history of immunocompromised, who experienced the unexpected serious AESI of Pancreatitis. The event occurred approximately 4 days after the second dose of mRNA 1273 vaccine. The re-challenge is positive since the patient experienced Pancreatitis 3 days after the first dose and also 2 days after the third dose of the mRNA 1273 vaccine (confirmed by blood workup).  The medical history of immunocompromised is a confounder for the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.