Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Hypokalaemia, Hyponatraemia, Influenza like illness, Nausea
Clinical narrative: Initial report was received from a healthcare professional through another manufacturer on 11 December 2012 under manufacturer control number 17098781. The following information was taken verbatim from the report: "This case was received from Institute (Cross Reference No: 5608). A clinical investigator reported that a 62-year-old male patient was hospitalized for nausea (grade III), vomiting (grade III) and hyponatremia (grade IV) on 26-Oct-2012, while enrolled in the study involving ipilimumab for melanoma. The patient also received acetaminophen, influenza virus vaccine, ondansetron and ibuprofen which were considered as suspect drugs. The patient was diagnosed with melanoma in Aug-2009 but had a recurrence in Apr-2012. The primary site of disease was noted in the right suprasternal area. Sites of metastatic disease included lymph node. The patient had not received any prior therapies. The patient was randomized to Arm A to receive ipilimumab. On 20-Jun-2012, the patient was initiated on study therapy with with intravenous ipilimumab 10mg/kg (over 90 minutes, once in every 3 weeks x 4 doses). The patient had received the total dose of 10mg of ipilimumab. He recently completed his induction course of ipilimumab on 22-Aug-2012. The patient had completed 4 induction courses of ipilimumab therapy. The patient had normal labs at last follow up appointment post ipilimumab on 24-Oct-2012. On the same day, the patient's baseline value of sodium was 135mmol/L. On 26-Oct-2012, the patient complained of lightheadedness and dizziness, nausea (grade III) and vomiting (grade III) and occurred almost every hour, also identified to have hyponatremia (grade IV) and hypokalemia. The patient also experienced grade I flu like symptoms. During admission patient was hydrated, CT of the brain done and did not show any acute intracranial abnormality, abdominal exam was benign. The patient presented to the emergency room on 28-Oct-2012 with resolving frontal headaches, fevers and chills. On the same day, patient's blood sodium level was 118mmol/L. Headache, hyponatremia, nausea and vomiting were resolved on 30-Oct-2012. On the same day, the patient's blood sodium level was 125mmol/L. The patient was not removed from the protocol due to the events. The patient's pre-existing condition included viral infection. Investigator reported that there were no other contributing causes for the events. According to the investigator, flu like symptoms was unrelated to ipilimumab, melanoma, acetaminophen, ibuprofen, ondansetron, but possibly related to influenza virus vaccine. The events of hyponatremia, nausea and vomiting were unrelated to melanoma. Investigator's causality assessment: Hyponatremia was unrelated to ipilimumab, acetaminophen and ibuprofen, but possibly related to influenza virus vaccine and ondansetron. Nausea was unrelated to ipilimumab and ondansetron, but possibly related to acetaminophen, influenza virus vaccine, and ibuprofen. Vomiting was unrelated to ipilimumab, acetaminophen, ibuprofen and ondansetron, but possibly related to influenza virus vaccine. Documents held by sender: None.