Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pancreatitis chronic, Paraesthesia
Clinical narrative: pancreas affected / Severe chronic pancreatitis; major joint pain and tingling and dropping all through the legs and feet; soreness; major joint pain and tingling and dropping all through the legs and feet; This spontaneous case was reported by a patient and describes the occurrence of PANCREATITIS CHRONIC (pancreas affected / Severe chronic pancreatitis) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020h22a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Batch No. 041b21a.) on 01-May-2021, Moderna COVID-19 Vaccine (Dose 2, Batch No. 001c21a.) on 29-May-2021, Moderna COVID-19 Vaccine (Dose 3 and Batch No. 039j21a.) on 30-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Drug allergy (Patient had a allergy to Gabapentin which had not used for a year and never took it again.). Concomitant products included HYDROMORPHONE HYDROCHLORIDE (DILAUDID), METFORMIN, FENOFIBRATE, SIMVASTATIN (STATIN [SIMVASTATIN]), PANTOPRAZOLE and INSULIN for an unknown indication.    On 16-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS CHRONIC (pancreas affected / Severe chronic pancreatitis) (seriousness criterion medically significant), PARAESTHESIA (major joint pain and tingling and dropping all through the legs and feet), PAIN (soreness) and ARTHRALGIA (major joint pain and tingling and dropping all through the legs and feet). At the time of the report, PANCREATITIS CHRONIC (pancreas affected / Severe chronic pancreatitis), PARAESTHESIA (major joint pain and tingling and dropping all through the legs and feet), PAIN (soreness) and ARTHRALGIA (major joint pain and tingling and dropping all through the legs and feet) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Reportedly, following vaccination with the 4th dose patient started to experience since 2 weeks ago soreness, his pancreas affected, major joint pain and tingling and dropping all through the legs and feet, patient was experiencing it every day. Patient stated he never had this side effect before. Patient had a Severe chronic pancreatitis and because of that patient was experiencing pain.  Patient received pain medication as a treatment medication for different situations and it does stopped it.  Company comment: This is a spontaneous case regarding a 63-year-old male patient, previously vaccinated with 3 doses of mRNA-1273 with a correct interval between doses, who experienced unexpected and medically significant event of chronic pancreatitis after receiving fourth dose of  mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). Onset date of the event was not provided, latency cannot be assessed. Relevant concomitant products included hydromorphone hydrochloride, metformin, fenofibrate, simvastatin, pantoprazole and insulin for an unknown indication. According to the report, following vaccination with the 4th dose, patient started to experience soreness, his pancreas affected, major joint pain and tingling and dropping all through the legs and feet. Patient stated he never had this side effect before. He reported that he had severe chronic pancreatitis and because of that he experienced pain. Treatment included unspecified pain medication. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concomitant product hydromorphone hydrochloride remains a confounding factor for arthralgia and paresthesia. Concomitant product simvastatin remains a confounding factor for pancreatitis and arthralgia. Concomitant products pantoprazole and fenofibrate remain confounding factors for pancreatitis. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case regarding a 63-year-old male patient, previously vaccinated with 3 doses of mRNA-1273 with a correct interval between doses, who experienced medically significant event of chronic pancreatitis after receiving fourth dose of  mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). Onset date of the event was not provided, latency cannot be assessed. Relevant concomitant products included hydromorphone hydrochloride, metformin, fenofibrate, simvastatin, pantoprazole and insulin for an unknown indication. According to the report, following vaccination with the 4th dose, patient started to experience soreness, his pancreas affected, major joint pain and tingling and dropping all through the legs and feet. Patient stated he never had this side effect before. He reported that he had severe chronic pancreatitis and because of that he experienced pain. Treatment included unspecified pain medication. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concomitant product hydromorphone hydrochloride remains a confounding factor for arthralgia and paresthesia. Concomitant product simvastatin remains a confounding factor for pancreatitis and arthralgia. Concomitant products pantoprazole and fenofibrate remain confounding factors for pancreatitis. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.