Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pancreatitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (each time I get pancreatitis/diagnosed with pancreatitis one day after third dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 084M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included AMITRIPTYLINE for Headache, BUPROPION HYDROCHLORIDE (WELLBUTRIN), SERTRALINE HYDROCHLORIDE (ZOLOFT), FOLIC ACID, COLECALCIFEROL (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 20-Nov-2021, the patient experienced PANCREATITIS (each time I get pancreatitis/diagnosed with pancreatitis one day after third dose) (seriousness criteria hospitalization and medically significant). At the time of the report, PANCREATITIS (each time I get pancreatitis/diagnosed with pancreatitis one day after third dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Blood test: abnormal (abnormal) Blood work detected pancreatitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was treated with pain and Nausea Medication.  Company's comment: This is a Spontaneous case concerning a 71-year-old, female patient with medical history of immunosupresion under treatment with denosumab and rituximab and also receiving bupropion, amitryptiline and sertraline,  who experienced the unexpected serious (hospitalization and medically confirmed and AESI) event of Pancreatitis. The event occurred approximately one day after the third dose of mRNA 1273 vaccine. This was confirmed by blood workup and patient is currently hospitalized due to it. Patient experianced Pancreatitis 3 days after the first dose and also 4 days after the second dose of the mRNA 1273 vaccine (confirmed by blood workup).  The medical history of imunosupression is a confounder for the event and the drugs bupropion and denosumab are co suspects.   The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395640, MOD-2021-395647 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up received contains added reporter information, patient demographic details, lab details, Suspect vaccine details added, concomitant medication added, Start date of event added, Hospitalization criteria for event added and Added Treatment medication in narrative.; Sender's Comments: This is a Spontaneous case concerning a 71-year-old, female patient with medical history of immunosupresion under treatment with denosumab and rituximab and also receiving bupropion, amitryptiline and sertraline,  who experienced the unexpected serious (hospitalization and medically confirmed and AESI) event of Pancreatitis. The event occurred approximately one day after the third dose of mRNA 1273 vaccine. This was confirmed by blood workup and patient is currently hospitalized due to it. Patient experianced Pancreatitis 3 days after the first dose and also 4 days after the second dose of the mRNA 1273 vaccine (confirmed by blood workup).  The medical history of imunosupression is a confounder for the event and the drugs bupropion and denosumab are co suspects.   The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.