Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Affective disorder, Aggression, Agitation, Condition aggravated
Clinical narrative: This case was reported by a physician participating in a study conducted by Pfizer and described the occurrence of mood disorder exacerbation in a 12-year-old male subject who was vaccinated with DTaP, (manufactured unspecified), meningococcal b c (non-gsk) as part of clinical study for Pfizer. The study conducted by Pfizer is to assess the safety, tolerability and immunogenicity of MCV4, TDAP and RLP2086 when administered concomitantly in healthy subjects aged to 10 to less than 13 years old." Co-suspect medication included THORAZINE, CATAPRES, DEPAKOTE, DESYREL, VYVANSE and PROZAC. Concurrent medical conditions included attention deficit hyperactivity disorder, enuresis, gastroesophageal reflux disease, mood disorder with previous hospitalizations and obesity. On 9 April 2013 the subject received blinded therapy at "1DF, intramuscular single dose of immunization [unspecified dose of DTaP (intramuscular), unspecified dose of meningococcal (Non-GSK) (intramuscular), The patient previously received a dose of blinded therapy at 11-years old on 09 October 2012". On 21 September 2013, 5 months after vaccination with DTPa and meningococcal (Non-GSK), 6 months after starting THORAZINE, 92 days after starting DEPAKOTE, 19 months after starting CATAPRES, 96 days after starting DESYREL, 6 months after starting VYVANSE and 10 months after starting PROZAC, the subject experienced mood disorder, condition aggravated, combative, agitation and violence. The subject was not recovered from the adverse events and was not been discharged from hospital. Per Pfizer the investigator considered there was a reasonable possibility that the events combative, agitated and violent were related to CATAPRES or DEPAKOTE or DESYREL or VYVANSE or PROZAC or THORAZINE, but not related to study drug and clinical trial procedure." On 05 October 2013 it was reported by investigator via Pfizer "that the patient was hospitalized on 21 September due to subject being combative, agitated and violent". "The subject was brought to the Emergency department on 21 September 2013 and subsequently admitted to the Pediatric Psychiatric Unit. Subject presented being combative, agitated and violent. As per hospital notes the subject presented mood disorder exacerbation. He participated in individual and group therapy; and was follow-up with outpatient psychiatrist. Subject was discharged from the hospital to home on 27 September 2013 recovered in stable condition. Medications were adjusted during the hospitalization as follows: CATAPRES continued at 0.2 milligrams nightly oral throughout the hospitalization and to be ongoing. Additional dose was added during the hospitalization and to be ongoing of 0.1 milligram (half tablet) twice a day. DEPAKOTE 250 milligrams continued and dose reduced from three times a day to two times a day during the hospitalization and to be ongoing. DESYREL continued at 12.5 milligrams nightly oral throughout the hospitalization and to be ongoing. VYVANSE at 40 milligrams every evening oral and 20 milligrams at noon oral both discontinued during the hospitalization and both to remain discontinued after discharge. PROZAC continued to 10 milligrams daily oral throughout the hospitalization and to be ongoing. THORAZINE continued at 20 milligrams three times a day oral throughout the hospitalization and to be ongoing. Additional dose of 25 milligrams every eight hours as needed for agitation or aggressive behavior throughout the hospitalization and to be ongoing. None relevant test were performed." "New SAE provided as "Mood Disorder Exacerbation" with onset date 21 September 2013, seriousness criteria provided as hospitalization/ prolongation of hospitalization, status of SAE at the time of last observation was provided as recovered with recovery date of 27 September 2013." "As per investigator there was not a reasonable possibility that the event Mood Disorder Exacerbation was related to study drug and clinical trial procedure but related to concomitant drugs: CATAPRES, DEPAKOTE, DESYREL, VYVANSE, PROZAC and THORAZINE." On 10 October 2013 it was reported by investigator via Pfizer that "oral VYVANSE at 40 milligram every evening and 20 milligrams at noon was discontinued on 24 September 2013. CATAPRES dose was increased. THORAZINE at 20 milligrams three times a day oral continued throughout the hospitalization and to be ongoing. Additional dose of 25 milligram every eight hours oral as needed for agitation or aggressive behavior continued throughout the hospitalizations and to be ongoing." At the time of reporting the events were unresolved.