Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Chills, Cough, Feeling abnormal, Headache
Clinical narrative: Based on the additional information received on 07-Apr-2016 from the patient, a company suspect drug -influenza vaccine and a non-company suspect drug pneumococcal vaccine has been added. Based on the additional information received on 18-Nov-2015, the case was upgraded from non serious to serious as a serious event "chest cold" was added. Initial information regarding this sponsored solicited case was received on 21-Oct-2015 from a consumer (patient) via patient support program. This case involved a 77 years old elderly female patient who experienced burning each time on administration/ burning while injection went in, 21 days and chest cold 65 days after; flu unspecified time after, pneumonia, cold symptoms few months after, shoulder pain/ pain in the muscle of the shoulder and believed had a torn tendon, 06 months after receiving treatment with PRALUENT and unspecified duration after influenza vaccine and pneumococcal vaccine. Medical history included CABG, other forms of chronic ischemic heart disease and 200% blocked arteries. No past drugs and concomitant medications were reported. On 24-Aug-2015, the patient received her first alirocumab 75mg/ml injection at a dose of 75 mg every two weeks via subcutaneous route via alirocumab prefilled pen (lot number and expiry date: unknown) for mixed hyperlipidemia and high cholesterol. 21 days later after her second injection on 14-Sep-2015, the patient reported that it was burning. The patient received her third alirocumab injection on 28-Sep-2015 and fourth alirocumab injection on 12-Oct-2015 and reported that it was burning each time on administration. On 28-Oct-2015 (latency: 65 days), patient reported that she had a chest cold with fever and chills. Patient thought that she got it on a cruise due to others around her coughing. Symptoms were still ongoing and she had gotten antibiotics as corrective treatment from her family doctor. Reportedly, she has the flu and for about 3 days she has experienced headache, chills, fever, chest congestion, and that she just feels rotten. She reports that her doctor put her on alirocumab because she has high cholesterol and 200% blocked arteries. Also, she had a CABG that failed in the past. She states that she would not want to give the injection more than twice a week because it 'burns like heck' and when asked how long she was on it she had to ask her sister and states that 'my sister's my memory'. Patient reported that during every injection except for one, she had experienced burning while the injection went in and stopped when injection completed. Some injections burnt worse than others. Patient reported that she received an influenza vaccine (flu shot) the beginning of Dec-2015 (dosage regimen, lot/batch no. and expiry date not provided) and the next day in Dec-2015, few months after initiating the therapy with alirocumab, she developed cold symptoms with cough, scratchy throat and fever. It was reported that she had not fully recovered and the doctor advised to get the pneumococcal shot which patient received on 06-Jan-2016 (dosage regimen, lot/batch no. and expiry date not provided) for an unspecified indication. Reportedly, she developed cold symptoms following that shot also. Symptoms became severe and the patient was diagnosed with pneumonia on 22-Feb-2016 and started on LEVAQUIN for 10 days. Symptoms were resolved with the antibiotic but the patient developed shoulder pain on 07-Mar-2016 (latency: 06 months). Reports told that a side effect of the antibiotic was spontaneous torn tendons within 6 months. Around 07-Mar-2016 developed pain in the muscles of the shoulder and believed had a torn tendon because pain was coming down arm. Patient was following up with MD. Therapy with alirocumab remained ongoing as planned (no action taken in response to the event). Action taken and therapy status was unknown with influenza vaccine and pneumococcal vaccine. Outcome: recovered/ resolved for 'it has been burning each time on administration' and not recovered for "chest cold", 'pneumonia', 'flu', 'cold symptoms', 'cough' and 'shoulder pain/ pain in the muscle of the shoulder and believes has a torn tendon'. Seriousness criteria: "chest cold" and "pneumonia" were considered as important medical events. Reporter causality: unknown for 'chest cold' and 'it has been burning each time on administration/ burning while injection goes' in with alirocumab, Associated for 'pneumonia', 'cold symptoms' and 'shoulder pain/ pain in the muscle of the shoulder and believes has a torn tendon' with alirocumab, not reported for 'flu' with alirocumab and not reported for all the events with influenza vaccine. Company causality: associated for " it has been burning each time on administration/ burning while injection goes in " with alirocumab, and not associated for "chest cold", 'pneumonia', 'flu', 'cold symptoms' and 'shoulder pain/ pain in the muscle of the shoulder and believes has a torn tendon' with alirocumab and not associated for all the events with influenza vaccine. Based on the additional information received on 18-Nov-2015 from consumer: Case was upgraded from non serious to serious as a serious event "chest cold" was added. Overall company causality was updated from associated to not associated. Therapy details updated. Narrative amended accordingly. Additional information was received from the patient via the patient support program on 15-Feb-2016: medical history added. Indications of alirocumab added. Event of flu with symptoms added. Symptom of chest congestion added. Clinical course updated and text was updated accordingly. Additional information was received on 07-Apr-2016 from the patient: Added events of 'pneumonia', 'cold symptoms' and 'shoulder pain/ pain in the muscle of the shoulder and believes has a torn tendon', updated as reported event term from 'it has been burning each time on administration' to 'it has been burning each time on administration/ burning while injection goes in', added company suspect - influenza vaccine and non-company suspect drug - pneumococcal vaccine, updated medical history and updated indication of suspect drug - alirocumab, updated clinical course and amended the text accordingly. Sender's Comments: Sanofi company comment for follow-up dated 07-04-2016: This case concerns an elderly female patient who developed chest cold and pneumonia while on therapy with Alirocumab. The causal role of Alirocumab is assessed as not associated due to lack of detailed information about patient's medical history, family history, concomitant medications and past drugs.