Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Obstructive airways disorder, Swollen tongue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 63-year-old female patient who received FLUARIX quadrivalent (batch number 3L7MZ, expiry date 30th June 2016). Co-suspect products included amlodipine + benazepril for cardiomyopathy. Previously administered products included Shingles vaccine with an associated reaction of injection site reaction (received it in June 2015 and experienced local reaction at the injection site that lasted for a week for which, the patient was treated with antihistamine). Flu trivalent vaccine (received last year and did not experience any adverse event) and Flu vaccine (the patient received flu shot for years and never had any reaction to any prior flu vaccination or any other medication). Concurrent medical conditions included cholesterol and cardiomyopathy. Concomitant products included simvastatin, MELANX, low dose aspirin and vitamins. On 16th October 2015, the patient received FLUARIX quadrivalent. In 2010, the patient started amlodipine + benazepril at an unknown dose and frequency. On 16th October 2015, 7 hrs 30 min after receiving FLUARIX quadrivalent, the patient experienced injection site pain and joint pain. On 17th October 2015, the patient experienced allergic reaction, swallowing difficult and airways obstruction. On an unknown date, the patient experienced swollen tongue and injection site warmth. The patient was treated with acetaminophen, epinephrine hydrochloride, SOLU-MEDROL injection, famotidine injection, BENADRYL injection and prednisone. Amlodipine + benazepril was discontinued on 16th October 2015 (Dechallenge was positive). Rechallenge with amlodipine + benazepril was unknown. On 17th October 2015, the outcome of the allergic reaction, injection site pain, joint pain, swollen tongue, swallowing difficult, airways obstruction and injection site warmth were recovered/resolved. It was unknown if the reporter considered the allergic reaction, injection site pain, joint pain, swollen tongue, swallowing difficult, airways obstruction and injection site warmth to be related to FLUARIX quadrivalent. Additional details provided were as follows: The patient was a nurse practitioner and vaccinated herself with FLUARIX quadrivalent on 16th October 2015 at 12:30. Same day at 16:00, 3 hours and 30 minutes after vaccination, the patient noted her joints were aching. Also the same night at 8:00pm, 7 hours and 30 minutes after vaccination her arm started hurting (injection site pain) which lasted for 4 hours. No redness was present. Before going to bed the patient took 2500mg tablets of generic acetaminophen and 81mg aspirin, simvastating 20mg, METANX and her vitamins. On 17th October 2015, patient woke up around 7:30 am, 19 hours after vaccination and could not move tongue as it was swollen 4 times than the normal size. On 17th October 2015, 1 day after vaccination, the patient was seen at local emergency room due to swelling of tongue occluding airway, and difficulty swallowing saliva, she noted her lungs were OK. When patient arrived at the emergency room at 8:57 she could barely speak and the patient was told that she was having an allergic reaction. On 17th October 2015, at 08:57 am, 20 hours and 27 minutes after vaccination, the patient's injection site was warm, but was not red. The patient was treated with epinephrine hydrochloride 0.15 mg, intramuscular, SOLU-MEDROL 125mg IV push, Famotidine 20mg IV push and generic BENADRYL 50mg IV push. The symptoms abated. The emergency room physician placed patient on a 5 day course of prednisone 60 mg. The patient ended up taking 40mg on day 1 and day 2, 30 mg on day 3, 20 mg on day 4 and 10mg on day 5. The patient was in the emergency room from 8:57 am until discharge at 1:30 pm same day. The patient had 2 glasses of white wine with her dinner and is not sure if this interacted with the vaccine or not. The patient was taking Amlodipine plus Benazepril combo for 5 years for cardiomyopathy without any difficulty. The emergency room physician discontinued the combo and stated that the adverse events as possible reaction to this drug. The patient's last dose of combo was at 7:30am the morning of vaccination.