Age: 83.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Frequent bowel movements, Immediate post-injection reaction, Injection site haemorrhage, Myalgia, Pain
Clinical narrative: Upon internal review on 15-Jan-2016; information about suspect product has been amended. Influenza vaccine was added as an additional company suspect. Based upon the follow up information received from the patient via the patient support program on 17-Dec-2015, the reporter causality was updated from not associated to unknown and company causality was updated from associated to not associated. Based on the follow up information received on 24-Nov-2015 the reporter causality was updated from unknown to not associated and company causality was updated from not associated to associated. Initial information regarding a clinically sponsored solicited case was received on 08-Oct-2015 from a patient via a program. This case concerns an 82 years old male patient who experienced injection site bleeding, lightheaded, abdominal cramping/ stomach cramps, increased bowel movements, upset stomach and muscle pain and soreness on the same day, diarrhea after an unknown duration and face "broke out with red spots" after few months of receiving treatment with PRALUENT and all unspecified time after receiving influenza vaccine. The patient had medical history of heart disease, COPD and asthma. The patient had allergy to NEOSPORIN, iodine, IVP dye and ZYCLARA. Concomitant drugs included IMDUR, PLAVIX, Aspirin and atenolol, all for heart disease. On 24-Sep-2015, the patient received his first injection with alirocumab at a dose of 75 mg every other week subcutaneously (lot/batch number: 5F005AC and expiry date unspecified) for mixed hyperlipidemia, high cholesterol, raised LDL and intermediate coronary syndrome. After first injection, patient stated that he experienced bleeding at the injection site immediately after the injection (date: 24-Sep-2015; latency: same day), lightheaded for 2-3 hours after the injection, abdominal cramping and increased bowel movements for several days after the injection. On 24-Sep-2015 (same day), the patient experienced upset stomach and had muscle pain and soreness to some extent. Upon follow up, it was stated that the patient took alirocumab 03-Dec-2015 and then had influenza vaccine (route, form, dose, frequency, strength, lot/batch number, expiration date and indication not provided). He experienced stomach cramps and on an unknown date in Dec-2015, face "broke out with red spots" and diarrhea for 2 days. Previous alirocumab shot caused mild diarrhea (onset date and latency: unknown) since an unknown date in Dec-2015. Action taken: unknown for influenza vaccine and no action taken for alirocumab. It was not reported if any corrective treatment had been required. Outcome: unknown for abdominal cramping/stomach cramps and face "broke out with red spots", not recovered for muscle pain and soreness and Recovered for all other events. Reporter causality: with alirocumab: not associated for lightheaded, increased bowel movements, injection site bleeding, Unknown for abdominal cramping/stomach cramps, face "broke out with red spots" and diarrhea and not reported for muscle pain and soreness. With influenza vaccine: not reported. Company causality: with alirocumab: associated for injection site bleeding and not associated for all other events. With influenza vaccine: not associated. Additional information was received from the patient via the patient support program on 24-Nov-2015: Height and weight of the patient was added. Medical history, past drugs and allergy history added. Reporter causality was updated from unknown to not associated and company causality was updated from not associated to associated. Indication of alirocumab added as raised LDL. Therapy start date and event onset dates was updated from 23-Sep-2015 to 24-Sep-2015. Clinical course updated and text was updated accordingly. Additional information was received from the patient via the patient support program on 17-Dec-2015: Indications were updated. Event term was updated for abdominal cramping. New events of red blotches and diarrhea were added. Reporter causality and company causality were updated. Text was amended accordingly. Addendum: information about suspect product has been amended. Influenza vaccine was added as an additional company suspect. Additional information was received on 01-Mar-2016: New events and concomitant medications were added and text was amended accordingly.