Sex: M
Vaccine: COVID19
Symptoms: Body temperature, C-reactive protein, Fatigue, Full blood count, Investigation
Clinical narrative: fatigue; This spontaneous report received from a patient concerned a 54-year-old male. The patient's weight was 240 pounds and height was 69 inches. The patient's past medical history included: appendicitis, and appendectomy in 2001 and concurrent conditions included: abstains from alcohol (on thanks giving day the patient had one glass of wine), nonsmoker, hypertension which was controlled with medication, and allergy to flagyl. The patient did not had any drug abuse or illicit drug use. The Patient mentioned he never had pancreatitis previously. The Patient did not have trauma, injury and infections and lives as active lifestyle. The Patient had no illness at the time of vaccination and had no adverse event after any previous vaccinations. The Patient did not had history of allergies to vaccine and food. The Patient did not had any preexisting acute illness 30 days prior to vaccinations. There was no history of hospitalization in the Last 30 days, and the cause, and had no family history of any diseases (relevant to vaccination, that is clotting disorders, autoimmune disorders, cardio-vascular) or allergies. On unspecified dates in Apr2021, the patient previously received the series bnt 162 (manufacturer: Pfizer) (form of admin, route of admin and batch number: unknown expiry: unknown) dose was not reported, for prophylactic vaccination (dose number in series 1).  On an unspecified date, following vaccination with non-company vaccine bnt 162 the patient experienced fatigue (Dose number in series 1)  The outcome of fatigue was not reported.  On 18Nov2021 patient received non company suspect vaccine: influenza vaccine (form of admin, route of admin, and batch number unknown expiry: unknown) dose was not reported, for prophylactic vaccination. On the same day booster vaccine was administered with flu vaccine.  On 18Nov2021 the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination on left arm (dose number in series 2) .The batch number was not reported and has been requested. No concomitant medications were reported. 12 to 24 hours after vaccination, the patient experienced fever, chills and fatigue (dose number in series 2). Concomitant medications included lisinopril for hypertension.  On 28Nov2021 the patient began experiencing severe epigastric pain around 12pm.That same evening at 7 or 8 pm, patient went to local hospital emergency room (ER) since the pain was not resolving. The patient was seen and treated for acute pancreatitis (dose number in series 2) with treatment medications which included: pain medications (unspecified) and an antiemetic (Unspecified) . Laboratory data included: CAT (computed tomography) scan abdominal which confirmed acute pancreatitis diagnosis. Laboratory data included: Amylase level (NR: not provided) pretty much.   On 29Nov2021(Monday) at 1 am, the patient was discharged from the emergency room (ER). At the time of discharge, the patient was given hard copy and the patient did not see the repeat lab, only received the message that they were within normal limits. On 30Nov2021 (Tuesday) the patient followed up with gastroenterologist who confirmed the diagnosis of acute pancreatitis but unsure of the cause. It was reported by the patient that he recovered and was on a low fat Diet. On 10Dec2021(Friday) patient had repeated amylase level lab test which came back normal. The patient has a scheduled for an abdominal MRI (Magnetic resonance imaging) for 20Dec2021 for further evaluation of the cause. It was reported that patient felt better, not sure if issue was with pancreas because patient had been having back pain and had consultation. This had happened in the past radiates to that place in his back. On an unspecified date patient underwent with lab tests: Complete blood count, Lipase, Erythrocyte sedimentation rate, C-reactive protein, Hepatic enzyme, Renal function test, stool routine, abdominal ultrasound with normal result.  The action taken with covid19 vaccine ad26. cov2 .s,and influenza vaccine was not applicable.  The patient recovered from acute pancreatitis, and the outcome of fatigue, chills, fever and back pain was not reported.   This report was serious (Other Medically Important Condition).  Additional information (addendum) was received from (telephone communication Log) on 22Dec2021. The following information was updated and incorporated into the case narrative: reporter contact and past event fatigue added and relevant fields updated. Upon review following information was amended: number of days hospitalized removed for event acute Company Remarks (Sender's comments)   V2: This follow up adds information about reporter, past event fatigue and relevant fields updated. This does not alter the previous causality assessment of the reported event.  #-covid-19 vaccine ad26. cov2. S-Acute pancreatitis. This event s is considered unassessable. The event s has a compatible/ suggestive temporal relationship, is unlabeled and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200062167 Same patient, same drug, different dose