Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from patient's mother via Regulatory Authority referring to a 14 month old male patient. The patient's medical history included an unspecified peroxisomal disorder, verified as the indication. As further testing was inconclusive (the patient was heterozygous for NPCI, GPBAR1, NOTCH2, and PEX 10); congenital bicuspid aortic valve; increased liver function test (GGT, INR, bilirubin, alkaline phosphatase, AST (aspartate aminotransferase), ALT (alanine aminotransferase). On 17-AUG-2017 the liver tests results were found to be ALT 228 U/L, AST 257 U/L, alkaline phosphatase 744 U/L]); bilateral congenital total and subtotal cataracts and congenital nuclear cataracts; congenital nystagmus; Elschnig pearls following cataract surgery; gastrostomy tube placement (was taking formula both orally and by G-tube); abnormal eye movements; low birth weight; bilateral deprivation amblyopia; bilateral aphakia; malnutrition; cholestasis; chronic liver disease; and failure to thrive. The patient also experienced the following historical events, prior to 17-APR-2018: a serious adverse event of G-tube site inflammation and the non-serious adverse events of: inflammation, positive test for RSV (respiratory syncytial virus); diarrhea with watery and green stools, abnormal stool odor, coughing that led to vomiting, five ounce weight loss from being sick, cold symptoms, triglyceride level of l00, double car infection, irritation and inflammation in his stomach, AST mildly elevated, Unspecified liver enzymes increase, fluctuating weight, and croup. The patient's height was not reported. On 09-OCT-2017, the patient's weight was 14 pounds and 13.5 ounces. On 29-SEP-2017, the patient started treatment with CHOLBAM 50 MG, 50 MG, twice daily via an unspecified route, for an unspecified peroxisomal disorder. Prior to event onset, on 19-OCT-2017, the patient's liver enzymes were still elevated, though decreased from baseline: ALT 176 U/L, AST 135 U/L, alkaline phosphatase at 386 U/L, GGT (gamma-glutamyltransferase), was also elevated but was slowly trending down. On 19-OCT-2017, the INR (international normalized ratio) and bilirubin levels were normal. On 26-DEC-2017, the ALT level was "slightly elevated" (value unknown). AST was slightly elevated (date unknown) and in February 2018, unspecified liver enzymes were elevated. On an unspecified date in February 2018, the patient's labs showed an elevated ALT level at 96 (units not specified) and an increased AST level at 76 (units not specified). In March 2018, both levels increased to ALT of 218 and AST of 81. In addition, the patient's GGT was elevated to 47 (units not specified). The patient had not yet had any of his 1-year vaccines and the pediatrician recommended he get one at a time, not to overload the liver. As of 26-FEB-2018, the patient's weight was 18 pounds, 9 ounces. On 17-APR-2018, the patient was vaccinated with M-M-R II (Lot #, expiration date, dose and frequency unknown) for an prophylaxis. On 20-APR-2018, the patient's ALT was 976 (units not reported) and AST was 484 (Units not reported). Treatment with CHOLBAM was stopped and treatment with the unspecified vitamins were adjusted to every other day. The patient's mother was taking him to get labs drawn every three days, and on 23-APR-2018, the ALT was 1012 (Units not reported) and the AST was 428 (Units not reported). On 28-APR-2018, the patient broke out in a smooth, "measles rash" all over his body. As of 02-MAY-2018, the ALT level was improved to 798 (Units not reported) and the AST was slightly improved to 411 (Units not reported). The GGT level was still elevated at 90 (Units not reported). The status of the rash was not reported. The patient's mother was planning to re-start CHOLBAM the evening of 02-MAY-2018, at 50 MG for one week, at which point the physician would re-evaluate. The outcome of the events was not reported. The causality assessment was not reported.