Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Blood thyroid stimulating hormone increased, Chemotherapy, Computerised tomogram abnormal, Fatigue
Clinical narrative: This spontaneous case, initially received on 01-Nov-2016, was reported by a non health professional and concerns a male patient. Weight: not provided; Height: not provided. Past medical history included diabetes, hiatal hernia and acid reflux. Drug history includes YERVOY (indication: melanoma, reaction: stomach upset, itching, rash, weight loss) and penicillin (reaction: hives). At the time of the event the patient had malignant melanoma. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: Chemotherapeutics (KEYTRUDA), Indication: Melanoma. Adverse reactions/events and outcomes: On an unknown date, the patient experienced fatigue after starting chemotherapeutics (KEYTRUDA). On an unknown date, the patient experienced itching and a mild rash mainly on his torso and legs 'which comes and goes'. He stated that itching was a little more intense but tolerable after the first 3-4 infusions and the rash was on his chest and arms also. Lately, the patient has not seen much of the rash, but the itching was more steady. The patient stated that after his last infusion on 07-Oct-2016, he felt a little more unwell. The outcome was reported a not recovered. Treatment was not given for the AE (adverse event). Relevant test results: CT scan: After receiving chemotherapeutics (KEYTRUDA), every CT scan has shown that the spots in his lungs are stable or decreased in size. Additional information was received on 12-Jan-2017. On 04-Nov-2016, the patient reported that rash had resolved but the itching was more or less steady thing. He was still experiencing fatigue since starting KEYTRUDA. His TSH was high. On 01-Nov-2016, his thyroid function test was repeated and the result was normal. On 21-Nov-2016, it was reported that the itching continued but was not bad and was tolerable. the patient took CLARITIN for seasonal allergies which started on an unknown date before starting KEYTRUDA. The patient felt that gliclazide helped reducing the itchiness. The patient was still experiencing fatigue since starting KEYTRUDA but it was not debilitating. The patient just lied down and rested when he was fatigued and he recovered from fatigue. Some days he felt more tired and other days he was not very tired. He reported that his feet and legs were a little achy a few days after each infusion. Once he gets up and walks around, the achiness in his feet and legs goes away. The spots on his back have been stable. On an unspecified date, the patient had a CT scan which showed that the spots on his back and his lungs were the same or slightly smaller. On 15-Dec-2016, the patient reported that his feet and legs ache in the morning since starting KEYTRUDA but after he walks around, the achiness goes away. He stated that his side effects were minimal and did not feel like he was sick. On 05-Jan-2017, the patient reported that on an unspecified date, he had a CT scan and it showed that the areas along the chest were the same, no growth and another area was slightly smaller. Nothing was developing in the lung. Since an unspecified date on 2013, he had a small area on the hilum of one lung that had increased in size slightly but his oncologist was not concerned. On unspecified dates, his blood pressure was slightly elevated. It could be that his blood pressure medication ZIAC needed to be adjusted.