Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphonia, Dysstasia, Erythema multiforme, Hepatic enzyme increased, Influenza like illness
Clinical narrative: Initial information regarding this unsolicited case was received on 08-Dec-2016 from a physician (who is also the patient). This case concerns a 79 year old male patient who experienced an increase in liver enzymes (latency: unknown), after receiving alirocumab (Praluent). The patient had a history of ASCVD. On 19-Sep-2016, the patient initiated treatment with subcutaneous alirocumab 75 mg/ml injection at a dose of 75 mg every other week (lot/batch number and expiration date: unknown) delivered via alirocuamb prefilled pen for pure hypercholesterolemia. The patient reported an increase in liver enzymes (onset date: 2016 and latency: unknown), but was not sure if it was completely due to alirocumab. The patient indicated he would be monitoring his liver enzymes. The patient's last dose should have been on 23-Nov-2016 or 24-Nov-2016. Action taken: no action taken. Treatment with the suspect drug was maintained.  Corrective measures: unknown. Outcome: unknown.  Reporter causality: not sure if it was completely due to alirocumab. Follow up report received from physician in 30-Dec-2016.  This case involves patient who was vaccinated with INFLUENZA VACCINE (Flu Shot), on 16-Nov-2016, received dose of ALIROCUMAB (Praluent) from 30-Aug-2016 to 1-Dec-2016 for every two weeks and ciprofloxacin (Cipro) (Batch number, expiry dates, site and route of administration was not reported) on an unspecified date. Patient had open heart surgery at the end of March 2010, triple bypass, and everything went fine ever since. Patient didn't have a heart attack.  On an unspecified date (reported that it may be started before 20-Nov-2016) patient following vaccination patient had "hoarseness and was constant until about Monday, 26-Dec-2016 or Tuesday 27-Dec-2016. On 20 Nov 2016, four days following vaccination patient experienced flu-like symptoms, "really bad like the flu on steroids. On an unspecified date early December 2016 following vaccination patient woke up with nausea, vomiting, aches all over, malaise, sinus wiped out, and no appetite, but no raging fever, "really wobbly when trying to get up, couldn't stand or walk, just weak, and developed a shaking fever of 102 degrees. On an unspecified date, following vaccination, patient had UTI (it was reported that due to flu like symptoms on 20 Nov 2016, patient thought it was a UTI). On an unspecified date 24 hours after taking Cipro patient had drug rash "erythema multiforme on arms and trunk, but not itchy. Patient reported had lost about thirteen pounds in that two to three week period. At the time of this report, the patient gained three pounds back and stated "he was not at one hundred percent but almost there." Lab test includes on an unspecified date patient performed flu test with negative result, flexible laryngoscopy with normal results, and on 14-Nov-2016 flexible cystoscopy. On 22-Nov-2016 urine tested but had not heard back so patient went to get urine re-tested on 25-Nov-2016 and it was normal. Other lab test includes alanine aminotransferase (ALT): 87, alkaline phosphatase (Alk phos): 159, aspartate aminotransferase (AST) 43, and total bilirubin 2.1. Outcome of UTI, flu like symptoms was not reported. patient was recovering from hoarseness (it was reported that it was 99 percent resolved).  Patient was recovered from other events.   Upon internal review the case was considered as serious because of important medical event: drug rash "erythema multiforme on arms and trunk, but not itchy. It was reported that flu shot could have contributed to the symptoms.; Sender's Comments: This case concerns a 79-year-old male patient with history of receiving Praluent 75 mg subcutaneous injection every two weeks for "pure hypercholesterolemia and ASCVD on 30Aug2016 (Exact starting date was unknown), who also received influenza vaccine (manufacturer unknown) on 16Nov2016 and experienced flu-like symptoms, nausea, vomiting, aches all over, malaise, sinus wiped out, and no appetite, really wobbly when trying to get up, couldn't stand or walk, just weak, and developed a shaking fever of 102 degrees, UTI patient also experienced hoarseness, drug rash to Cipro(given for the UTI) rash was "erythema multiforme on his arms and trunk, but not itchy and elevated liver enzymes. Time to onset (approx.. 4days) is compatible with the role of vaccine. Patient also had a history of open heart surgery, triple bypass and total bilirubin has always been in the upper limits of normal. However, very limited information is provided in this case. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies, exact time to onset are needed to further assess this case. Based on the available information, the role of the vaccine cannot be evaluated.