Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Gallbladder hypofunction, Impaired quality of life, Investigation
Clinical narrative: affecting his mental health; Found that his gall bladder was only functioning at 2%; unable to go to school; severe pain (abdomen); This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose 1, single (Lot number: EN0164) at the age of 12 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: ABDOMINAL PAIN (disability) with onset 2021, outcome "not recovered", described as "severe pain (abdomen)"; IMPAIRED QUALITY OF LIFE (disability) with onset 05Jan2023, outcome "unknown", described as "unable to go to school"; GALLBLADDER HYPOFUNCTION (disability, medically significant) with onset 13Mar2023, outcome "recovered with sequelae" (13Mar2023), described as "Found that his gall bladder was only functioning at 2%"; MENTAL IMPAIRMENT (disability, medically significant), outcome "not recovered", described as "affecting his mental health". The patient underwent the following laboratory tests and procedures: Abdominal pain: 8 out of 10, notes: He is an 8 out of 10 constantly and it is not controlled; Computerised tomogram: Unknown results; multiple tests: Unknown results. Therapeutic measures were taken as a result of gallbladder hypofunction, abdominal pain.  Clinical course: The patient other conditions and other products was reported as no. Caller stated that she about the Pfizer Covid vaccine. Has the lot number of EN0164. Is a pediatric nurse. Called about her son. Since the Pfizer Covid vaccine he has had severe abdominal pain. Started after the vaccine. Got worst. Went to the doctors and doctors. Went in to the doctors had multiple tests. No further details provided. Found that his gall bladder was only functioning at 2%. On 28Mar2023 had a cholecystectomy after two years of pain. Is still continuing to have affects from it. Still in a lot of pain. Looked up the timeline and it started after he had the Pfizer Covid vaccine. Was from the first vaccine. Only had one. Wanted to know if they have experienced this happening with children in this vaccine. Found that his gall bladder was only functioning at 2%: Found this on 13Mar2023. Is still having issues. Recovered with lasting effects. Treatment: Had to get his gallbladder removed. Had a upper/lower GI. No further details provided. Was on a lot of medications. Is still going to the doctors and getting tests. Cholecystectomy: Had it on 28Mar2023. Recovered with lasting effects of being unable to go to school and in severe pain. Is on a lot of medications. Is in a lot of pain. Is never free of pain. Treatment: Is still seeing his surgeon. Has to go in for a CT next week. Continue doctors appointments and tests. Severe pain: Clarified that it was in his abdomen. Started in 2021 shortly after the vaccine and got disabling in Dec2022. He is an 8 out of 10 constantly and it is not controlled. The lowest they can get it to is a 6 and that is not normal. Is ongoing. Is persisting. Treatment: Have him on pain medicine Norco and Ultram. Gives him Aleve and Zofran. Unable to go to school: Started since 05Jan2023. Has missed about 100 days. Have basically force him to go. When he goes usually get a call from the school nurse that he is in severe pain. Attempted to clarify dates; dates captured as he has been going to school these last 10 days. Recovered with lasting effects of probably going to fail the eight grade which is affecting his mental health. Treatment: Has been to specialists, surgeon, his pediatrician many times. Affecting his mental: Started this year after holiday when he started getting the severe pain. Date unspecified. Is ongoing. Treatment: None.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (ABDOMINAL PAIN, IMPAIRED QUALITY OF LIFE,GALLBLADDER HYPOFUNCTION,,MENTAL IMPAIRMENT) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.