Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, C-reactive protein, Headache, Ultrasound abdomen, White blood cell count
Clinical narrative: Appendicitis (vomited once, had overall malaise and specific lower right abdominal pain); headache; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis (vomited once, had overall malaise and specific lower right abdominal pain)) in a 12-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032169) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 50 microgram. On 22-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced HEADACHE (headache). On 27-Nov-2023, the patient experienced APPENDICITIS (Appendicitis (vomited once, had overall malaise and specific lower right abdominal pain)) (seriousness criterion medically significant). The patient was treated with Surgery (appendectomy) for Appendicitis. On 28-Nov-2023, APPENDICITIS (Appendicitis (vomited once, had overall malaise and specific lower right abdominal pain)) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2023, C-reactive protein: elevated. On 27-Nov-2023, Ultrasound abdomen: appendicitis. On 27-Nov-2023, White blood cell count: elevated.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 22-Nov-2023, The day the patient received the Covid booster, she vomited once (that night) and had a headache and overall malaise. She improved the next day. Four days later, she had specific lower right abdominal pain that was worse with moving, improved slightly with warm packs. The appendix was not perforated or ruptured but there was clear appendicitis upon removal of the appendix and further pathology. The patient did not experience any additional symptoms/events. patient had no risk factor.  Company comment-This is a spontaneous case concerning a 12-year-old female patient with no medical history reported who experienced the unexpected and serious (medically significant) AESI appendicitis 5 days after a dose of SPIKEVAX 2023-2024 vaccine, given as a booster dose of COVID vaccine schedule, was administered. It was reported the day the patient received the COVID booster, she vomited once (that night) and had a headache and overall malaise. She improved the next day. Four days later, she had specific lower right abdominal pain that was worse with moving, improved slightly with warm packs. Five days after vaccination, her mother brought her to Urgent Care, she was sent to the Emergency Department. Ultrasound was performed on the appendix, and lab work as well. CRP was elevated, as well as white blood cells with a left shift. She had markers indicative of appendicitis, and as a result, she underwent an appendectomy. The appendix was not perforated or ruptured but there was clear appendicitis upon removal of the appendix and further pathology. The event appendicitis was assessed as not related to SPIKEVAX 2023-2024 vaccine due to nature of the event. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report.