Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Coronary arterial stent insertion, Coronary artery stenosis, Diarrhoea, Fall, Headache
Clinical narrative: Based on the additional information received on 18-Oct-2016 by a consumer via patient support program, the reporter causality was updated from "Not reported" to "Unknown" and a new company suspect of "influenza vaccine" was added to the case. Initial information regarding this sponsored solicited case was reported on 04-Oct-2016 by a consumer via patient support program. This case involves a 72-year-old female patient whose widow maker was 99% blocked, low sodium, low potassium, pain in her legs and arms, nausea, vomiting, angina attack, oxygen level dropped, fell and good bruises, very sick, low grade fever, severe headache, diarrhea and blood pressure increased to 200/100 all after an unknown duration after starting Praluent and influenza vaccine. No past drugs, other relevant medical history or concomitant medications were reported. On 16-Sep-2016, the patient commenced treatment with subcutaneous alirocumab at a dose of 75 mg every other week (strength: 75 mg, form: unknown, batch/lot number and expiry date: 6F040A 31-MAR-2017) for pure hypercholesterolemia administered with alirocumab prefilled pen. In 2016, the patient received influenza vaccine (dosing details, lot/batch number and expiry date: unknown) for an unknown indication. On unknown dates, after unspecified latency, the patient had stents put in on the 8th because her widow maker was 99% blocked. Three days later, she went back into the hospital with low sodium and potassium. She said it was really bad, and she wasn't sure she was going to make it. She was there for 4 days with pain in her legs and arms, nausea and vomiting, an angina attack, and her face was pulling. Her oxygen level dropped while she was in the ER, and the nurse had to put her on oxygen. She also fell while in the hospital and got some good bruises. The patient reported she had a flu shot and her blood pressure was very high for about 24 hours. Reportedly, for a few days after receiving the flu shot, her blood pressure increased to 200/100 (onset and latency: unknown) and she doubled up on the blood pressure medicines. The patient was in the hospital September the 8th, 2016. She did not know what happen, but she became very sick, had a severe headache (Sep-2016: unknown latency) and a low grade fever. After she was admitted, she had vomiting and Diarrhea (Sep-2016: unknown latency for both) and the potassium and sodium level was critically low (2016: unknown latency for both). She also had a heart stent placed during the hospital stay. No action was taken and therapy with suspect was maintained (teriflunomide); Action taken for influenza vaccine was unknown. Corrective treatment: Not reported. Outcome: Unknown for blood pressure increased, diarrhea, severe headache, low grade fever, low potassium, low sodium and coronary arterial blockage; Not applicable for fall; Recovered from rest all the events. Reporter's causality: Not reported. Company's causality: Not Associated. Additional information received on 18-Oct-2016 by a consumer via patient support program: therapy details updated; new company suspect vaccine added: influenza vaccine; new events added, low grade fever, severe headache, diarrhea and blood pressure increased; event details updated for coronary arterial blockage, low sodium, low potassium and vomiting reporter causality updated to unknown. Narrative amended. Sender's Comments: Sanofi company comment dated 18-10-16- This case concerns a 72-years-old female patient who coronary arterial blockage, low sodium, low potassium, vomiting, low grade fever, severe headache and diarrhea while on Alirocumab. The causal role of the drug with the event cannot be assessed due to lack of adequate information about patient's past medical history, concomitant medications and concurrent conditions. However, patient's elderly age and underlying condition of hypercholesterolemia are the confounders for the same.