Age: 38.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Pancreatitis
Clinical narrative: Pancreatitis; Breakthrough covid case/Covid 19; This spontaneous case was retrieved on 13-Jul-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number 2338972-1), reported by other healthcare professional and concerned a 38-year-old, male patient.  The patient's concurrent conditions included chronic pancreatitis, chronic alcoholism, alcohol abuse and dependence, gastritis, anxiety, depression, diabetes mellitus (DM), hypertension (HTN), gastroesophageal reflux disease (GERD) and allergy to amoxicillin, allergy to codeine, allergy to penicillin, and allergy to sulpha. The patient's concomitant medications were not reported. The patient's historical vaccines included first two doses of Pfizer BioNTech COVID-19 vaccine (tozinameran) without reported adverse events.  On 28-Jan-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: intramuscular, anatomical location: right arm, indication: not reported). The batch number reported was P100360866.  On the same date, the patient was also vaccinated with non-company co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as 'three', route of administration: intramuscular, anatomical location: left arm, indication: not reported). The batch number reported was FL3198.  On an unspecified date in 2022, an unknown amount of time after receiving Afluria Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient presented to emergency room (ER) with complain of abdominal pain, nausea and vomiting. Also, the patient experienced COVID-19 (reported also as 'breakthrough covid case').   On an unspecified date in May 2022, an unknown amount of time after receiving Afluria Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccine, the patient was hospitalised for pancreatitis for three days and then discharged to rehabilitation.    On 21-Jun-2022, the patient had COVID test, however results were not reported. As reported, the patient had no other COVID symptoms.  On an unspecified date in 2022, the patient recovered from all events.  The reporter did not provide causality assessment.  The events of 'pancreatitis' and 'COVID-19' were considered as serious due to seriousness criterion of hospitalization. Additionally, the event of 'pancreatitis' was considered to be medically significant by a Physician within the Department.  Company comment: A 38-year-old patient experienced pancreatitis and COVID-19 an unknown amount of time after receiving the suspect product Afluria Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine. Underlying medical history was significant for chronic pancreatitis. Underlying medical history chronic alcoholism, alcohol abuse and dependence as well as gastroesophageal reflux disease contributed to the development of the event pancreatitis. Information regarding the related diagnostic findings was not provided. It was not specified whether the patient experienced aggravation of underlying pancreatitis or acute on chronic pancreatitis. Based on strong confounders, causality for the event pancreatitis is assessed as not related. Causality for the event COVID-19 is assessed as not related as well, due to biological implausibility.; Sender's Comments: A 38-year-old patient experienced pancreatitis and COVID-19 an unknown amount of time after receiving the suspect product Afluria Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine. Underlying medical history was significant for chronic pancreatitis. Underlying medical history chronic alcoholism, alcohol abuse and dependence as well as gastroesophageal reflux disease contributed to the development of the event pancreatitis. Information regarding the related diagnostic findings was not provided. It was not specified whether the patient experienced aggravation of underlying pancreatitis or acute on chronic pancreatitis. Based on strong confounders, causality for the event pancreatitis is assessed as not related. Causality for the event COVID-19 is assessed as not related as well, due to biological implausibility.