Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, C-reactive protein increased, Chills, Diarrhoea, Gastroenteritis
Clinical narrative: gastroenteritis; scan showed thickening of his cecum and terminal ileum; Increased C-reactive protein; Increased white blood cell count; Diarrhea very watery; Nausea; Numbness in hands and feet; tingling hands and feet; Chills; Stomachache; This non-serious case was reported by a physician via call center representative and described the occurrence of gastroenteritis bacterial in a 25-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 1st dose on an unknown date) and Hepatitis B vaccine (received 2nd dose on an unknown date).   On 12-AUG-2024, the patient received the 3rd dose of Engerix B. On 12-AUG-2024, 3 hrs after receiving Engerix B, the patient experienced stomach pain (Verbatim: Stomachache), nausea (Verbatim: Nausea), numbness in hand (Verbatim: Numbness in hands and feet), tingling of extremity (Verbatim: tingling hands and feet) and chills (Verbatim: Chills). On 13-AUG-2024, the patient experienced watery diarrhea (Verbatim: Diarrhea very watery). On an unknown date, the patient experienced gastroenteritis bacterial (Verbatim: gastroenteritis), gastrointestinal wall thickening (Verbatim: scan showed thickening of his cecum and terminal ileum), c-reactive protein increased (Verbatim: Increased C-reactive protein) and white blood cell count increased (Verbatim: Increased white blood cell count). The outcome of the gastroenteritis bacterial, c-reactive protein increased and white blood cell count increased were not reported and the outcome of the gastrointestinal wall thickening, stomach pain, watery diarrhea, nausea, numbness in hand, tingling of extremity and chills were unknown.   The reporter considered the gastroenteritis bacterial to be unrelated to Engerix B. It was unknown if the reporter considered the gastrointestinal wall thickening, stomach pain, watery diarrhea, nausea, numbness in hand, tingling of extremity, chills, c-reactive protein increased and white blood cell count increased to be related to Engerix B.     The company considered the gastroenteritis bacterial to be unrelated to Engerix B. It was unknown if the company considered the gastrointestinal wall thickening, stomach pain, watery diarrhea, nausea, numbness in hand, tingling of extremity, chills, c-reactive protein increased and white blood cell count increased to be related to Engerix B.   Additional Information: GSK receipt date: 15-AUG-2024 and 19-AUG-2024 Physician explained that his 25 year old son received a third dose of Engerix-B on August 12th 2024 (unknown lot number and expiration date). Caller was not sure but remembered that his son received maybe 2 prior Hepatitis B vaccines when he was a child but he did not know the brand, date of administration, or lot numbers. Physician explained that his son experienced very bad complications after getting the Engerix-B booster, a couple hours after the administration felt tingling and numbness in hands and feet. 3 hours later started with chills, nausea and stomachache. The next morning on August 13th 2024 started with Diarrhea and it went very watery, and diarrhea, chills and stomach pain happened every 2 to 4 hours. On August 15th 2024 patient went to Emergency Room and a Computer Tomography scan showed thickening of his cecum and terminal ileum, patient showed increased white blood cell count and increased C-reactive protein. Emergency room Visit Required The patient was diagnosed with confirmed bacterial gastroenteritis, so not vaccine related.