Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Adnexa uteri cyst, Alanine aminotransferase increased, Amylase decreased, Aspartate aminotransferase increased
Clinical narrative: Pancreatitis; Not able to eat much; The pain ended up being in the center of upper abdomen right under patient ribcage; Lymphocyte count decreased; Monocyte count decreased; Neutrophil count increased; Urine ketone body present; White blood cells urine positive; Alanine aminotransferase increased; Amylase decreased; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Gamma-glutamyl transferase increased; Diverticulum intestinal; Gastrointestinal wall thickening; Pancreatic cyst; Adnexa uteri cyst; Didn't get much sleep; This spontaneous case, initially received on 17-Dec-2024, was reported by a non-health professional and concerns an adult female patient.  Past medical history included Unable to eat, Sensitive oral reaction to walnuts, Sensitive oral reaction to bananas, Covid-19 vaccination, Computerised tomogram Pancreas, Scan with contrast, Computerised tomogram abdomen, Magnetic resonance imaging. At the time of the event the patient had Penicillin allergy. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug On 04-Oct-2024, the patient received Flucelvax (TIV) for Product used for unknown indication, Dose 1, Route of administration: intramuscular, Lot number: 946618.  Non-company suspect drugs (captured as procedure in structured fields of medical history section due to limitations of WHO Drug Browser).  Non-company suspect drugs: Novavax COVID-19 Vaccine, Adjuvanted 2024-2025 Formula (SARS-CoV-2 Spike protein (Omicron Variant JN. 1), (SARS-CoV-2 Spike protein (Omicron JN. 1 Subvariant) 0.5 ml (s) (injection) (6024 MF), Route of administration: intramuscular, Lot number: 6024MF012   Adverse reactions/events and outcomes:  On 05-Oct-2024, the patient experienced Didn't get much sleep (outcome: Unknown). On 07-Oct-2024, the patient experienced Diverticulum intestinal (outcome: Unknown), Gastrointestinal wall thickening (outcome: Unknown), Pancreatic cyst (outcome: Unknown), Adnexa uteri cyst (outcome: Unknown). On 07-Oct-2024, the patient experienced Pancreatitis (Medically Significant, outcome: Recovered / Resolved). Associated symptoms included: Not able to eat much, The pain ended up being in the center of upper abdomen right under patient ribcage, Lymphocyte count decreased, Monocyte count decreased, Neutrophil count increased, Urine ketone body present, White blood cells urine positive, Alanine aminotransferase increased, Amylase decreased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Gamma-glutamyl transferase increased.  The patient woke up at 2am Saturday morning with severe stomach pain. The patient didn't get much sleep after that, and the pain ended up being in the center of upper abdomen right under patient ribcage. It was bad enough that patient was not able to eat much but had no fever. The pain persisted throughout the weekend and at 8am on 07-Oct-2024, patient called primary care, they didn't have an appt until the afternoon, so patient went immediately to urgent care. They sent to the emergency room (ER). At the ER, patient had a CT scan and bloodwork along with an IV of hydration. The CT scan showed pancreatitis and LFT were elevated. They sent patient home with a STAT appt to see a Gl physician the following morning. They scheduled appointment for LFT again on Thursday with an MRI in a few weeks. Patient LFT on thursday were even more elevated so they scheduled for an MRCP with and without contrast the same day. This test showed pancreatitis but nothing in gallbladder (the CT scan had showed a normal gallbladder as well). They then scheduled with a general surgeon to get her opinion on next steps and had patient repeat LFT the following week. Those came back at normal and following levels. Patient did go to a surgeon appt where she said that nothing showed gallbladder involvement, but they scheduled patient for an ultrasound just in case. They said it was related to my vaccinations. The ultrasound came back completely normal and showed that pancreatitis had resolved, and gallbladder was completely normal.   Relevant lab tests included:  On 07-Oct-2024, UA POC (Result: All normal except Urine Leukocyte Esterase TRACE), Lipase (Result: Normal), comprehensive metabolic panel (Result: All in normal range except ALT (SGPT) 69), CBC with differential  lab (Result: All normal except Neutrophils 79.2, Lymphocytes 10.2, Monocytes Absolute 0.87), CT abdomen pelvis w IV cont and wo po cont(Result: The liver, spleen, and adrenal glands are within normal limits. Infiltrative changes are identified in the retroperitoneal fat posterior to the pancreatic head. Correlation with serum amylase and lipase is recommended. Acute pancreatitis was considered. There was a 4.0 cm left adnexal region cyst which may represent a large ovarian cyst. Diverticulosis was noted throughout the colon. There was no evidence of diverticulitis. No free fluid is noted. The bladder is within normal limits. No adenopathy was noted, urinalysis POC (Result: Urine Specific Gravity Value less than equal to l .005Low, Urine Ketone Value 15, abnormal),  On 10-Oct-2024, hepatic function panel (Result: All normal except: Alkaline Phosphatase 163, AST (SCOT) 49, ALT (SGPT) 134, Gamma GT 159, Lipase serum (Result: Normal), Amylase serum (Result: 26 Low). MR MRCP W/WO Contrast (Result: Peripancreatic inflammatory changes most predominantly centered at the pancreaticoduodenal groove that is most suggestive of groove pancreatitis without imaging findings of necrosis. Thickening of the descending portion of the duodenum may be secondarily involved. No solid pancreatic lesion. A tiny cyst is noted in the anterior pancreatic head which likely reflects an indolent lesion of epithelial origin (IPMN).   Radiology suggest one-year follow-up. No biliary duct dilatation or choledocholithiasis. MRCP images are motion degraded. Narrative MRCP with and without contrast History: Elevated LFTs, abnormal CT pancreas, evaluate for resolution of pancreatitis and evaluate for mass. Technique: Multiplanar multisequence MR imaging was obtained of the abdomen with and without intravenous contrast. Contrast: 14 ml Dotarem intravenously. Comparison: 07-Oct-2024. Findings: LOWER CHEST: Limited view of the lower chest was unremarkable. LIVER: No significant loss of signal on out of phase imaging to suggest steatosis. No solid or suspicious hepatic lesion. No features of cirrhosis. BILIARY: The MRCP images are motion degraded. There was no biliary duct dilatation. The gallbladder was present with no pericholecystic inflammation or imaging findings of acute cholecystitis. No findings to suggest choledocholithiasis on the basis of the coronal and axial T 2 haste images. SPLEEN: Normal in size and signal characteristics. No focal lesions. PANCREAS: There are mild peripancreatic inflammatory changes predominantly centered around  the pancreaticoduodenal groove. There was no main pancreatic duct dilatation. No solid pancreatic lesion. There was a minute cyst along the anterior inferior aspect of the pancreatic head measuring. 3 mm (image 25 series 4 and image 30 series 3).   On 10-Oct-2024, there was othemise homogeneous enhancement  of the pancreas. (Continues to Results Of Tests section).  On 18-Oct-2024, hepatic function panel (Result: All normal except Gamma GT 85 high) and us abdomen complete(Result: Impression LEFT renal cyst. No acute pathology.   Narrative Procedure: us abdomen complete on 30-Oct-2024 Comparison: CT ABD Pelv. On 07-Oct-2024 (acute pancreatitis), MR Mrcp 10-Oct-2024 Reason for Study: Recent Acute Pancreatitis, Concern for Gallstones Clinical History: None Technique: 2D-Color Doppler Liver: 15. 7 Size: Normal Echotexture: Normal Other Liver Findings: None Gallbladder: Findings: None Wall thickness: 2 mm Wall findings: None No tenderness over GB Bile ducts: CHD: 2 mm Findings: None CBD Prox: 3 mm CBD Dist: 2 mm Findings: None Pancreas: Findings: None Right Kidney: 10.8 x 4.5 x 4.8 cm Size: Normal Echotexture: Normal Other Right Kidney Findings: No hydronephrosis Left Kidney: 11.7 x 4.5 x 4.4 cm Size: Normal Echotexture: Normal Other Left Kidney Findings: No hydronephrosis, Cyst LK Single Cyst 1.4 x 1.2 x 1.0 cm mid pole simple Spleen: 10.3 cm Size: Normal size Other Spleen Findings: None IVC: Normal Aorta: Normal. Abdominal cavity: Free fluid: None, Test Date: 30-Oct-2024).   Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events Adnexa uteri cyst, Didn't get much sleep, Diverticulum intestinal, Gastrointestinal wall thickening, Pancreatic cyst, Pancreatitis as non-serious and related to the administration of Flucelvax (TIV). The event Pancreatitis upgraded to serious (Medically Significant) as important medical event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Of note, concomitant administration of COVID-19 vaccine might act as contributing factor for the events.