Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Urine ketone body present, White blood cell count increased
Clinical narrative: Initial report received on 20 September 2014 and follow up information received on 23 September 2014 and 25 September 2014 from an investigator participating in a study. A 10 year-old female subject was diagnosed with appendicitis on 15 September 2014 i.e. 21 days after receiving first intramuscular dose of the study vaccine MENVEO in right deltoid on 25 August 2014 (batch number: A14040). The event appeared after visit 01. The subject's medical history was not reported. The subject had concomitant therapies however the details were not provided. The subject's parent called and stated that the subject complained of abdominal pain on 15 September 2014. The subject was taken to a hospital and was admitted with appendicitis on 15 September 2014. No lab data was reported. Appendectomy was performed on 15 September 2014. The event of appendicitis was resolved on 15 September 2014. The subject was discharged from the hospital on 18 September 2014. According to the investigator, the event was not related to the study vaccine or trial procedures. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 08 November 2014. The start date of the event was changed to 16 September 2014 i.e. 22 days after the subject received study vaccine (previously reported as 15 September 2014). The subject had no concomitant medication. The subject was hospitalized on 16 September 2014 (previously reported as 15 September 2014). The subject's parent informed that the subject complained of abdominal pain on 15 September 2014. The subject was taken to a hospital and was admitted with Appendicitis. An appendectomy was performed on 16 September 2014. The subject's corrective treatment included laparoscopic appendectomy. The stop date of the event was changed to 17 September 2014 (previously reported as 16 September 2014). The subject was discharged from the hospital on 17 September 2014 (previously reported as 18 September 2014). Follow up information received on 24 November 2014 and 25 November 2014: The batch number of first dose of study vaccine MENVEO was M14040 (previously reported as A14040). The subject had symptom of abdominal pain started on 15 September 2014. The event of appendicitis was resolved on 16 September 2014 (previously reported as 17 September 2014) along with symptom of abdominal pain was resolved on 16 November 2014. Follow-up information received on 04 December 2014: In corrective treatment, it was updated that the subject had unspecified intravenous antibiotics of unknown milligrams. Addendum on 4 Dec 2014: significant correction performed to enter the modifier as company which was blank previously. Follow up information received on 20 January 2015: The subject had no medical history or risk factors. The lab investigations were reported as CT (Computed tomography) Scan of abdomen appendix with contrast on 16 September 2014 showed acute appendicitis with appendicolith without evidence of perforation or abscess formation. Complete blood count on 16 September 2014 was normal except WBC (white blood cells) 20.7, hemoglobin 12.0, segmented neutrophils 86, lymphocytes 5, absolute 17802. Basic Metabolic Panel was normal except Creatinine 0.38, Glucose 117, CRP (C-reactive protein) 2.50. Urine complete was normal except: Clarity Hazy, Blood/hemoglobin = trace, Ketones = 1+.