Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hypersomnia, Inflammation, Pruritus, Pyrexia
Clinical narrative: Based upon follow up information received on 23 FEBRUARY 2015, the cases considered as medically confirmed. Initial unsolicited report received from a Consumer (patient) on 19 JAN 2015. This case is linked to case number 2015SA014179 (same patient). A 56-year-old female patient, had received a 0.5 ml dose of FLUZONE QIV (lot number: UI158AB, expiry date 30 JUN 2015, route and dose  number not reported) in right deltoid on 27 OCT 2014. The patient had no illness at the time of vaccination. The patient had pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as reacted to preservatives in eye solutions for contact lens. The patient did not have any reaction to eggs - eat them all the time. The patient did not receive any previous dose of FLUZONE QIV. The patient had received a daily meds are LEXAPRO 5mp and topical ESTRIOL (plant based and ESTRODIAL 2mg) as a concomitant medications. On 27 OCT 2014 i.e. 10 hours after vaccination patient started to exhibit hives with no anaphylaxis. The patient called physician and started BENADRYL "2" every 4 hours at 7 hours hives covered all of my trunk back and front and by 10 hours after onset patient legs where cover almost to the ankles out extremities with spots and from the knees and elbows in solid raised inflammation fighting the skin. It was reported that with BENADRYL by 24 hours cover from earlobes to ankles, severe itching. The patient took ATARAX every 4 hours with CLARITIN. The patient condition persisted for a total of 5 days with a spike in fever to 100.5 and 2  hours later a fever drop and hives began to dissipate by 5 hours by 50%  by 24 hours 80%. Patient extremely tired and then slept for 24  hours. The patient took ATARAX one more day then it felt too strong - took BENADRYL one day then CLARITIN one more time as a corrective treatment. Laboratory investigations were not reported. It was reported that the patient took about a week to fully recover. Documents held by sender: none. Follow up information was received from a healthcare professional on 23 FEBRUARY 2015: The patient had medical history of high cholesterol, anxiety, post-menopausal. Mitral valve prolapse, breast exam in LA, smoker more than 10 year, allergies adhesive: raised red welts. The patient was on concomitant medication with red yeast rice 600 mg capsule 4 cap(s) once a day, Co !-10 100 mg oral capsule 1 tab once daily. The patient had received the dose of FLUZONE QIV vaccine via intramuscular route. The patient developed diffuse urticarial throughout on 27 OCTOBER 2014, large erythematous warm non blanching plaques over chest, abdomen, back, legs, arms and head on an unspecified date. Follow up information was received from a healthcare professional on 06 APRIL 2015. On the same date of vaccination, patient was covered in hives - face, neck, chest, abdomen, back, extremities. They were pretty itchy. Patient still having hives. The patient was taking 50 mg BENADRYL as directed several times a day. Patient did not have any current illness. No fevers although has felt chilled. No congestion, headache, sore throat, coughing etc. No mouth sores, sore throat or airway issues. No chest pain, SOB or wheezing. It was reported that patient was advised to do one more day of BENADRYL (confirm 25 mg of every 4-6 hours). Physician advised the patient to also start CLARITIN 10 mg daily and continue for 1 week.  Hives after flu shot: patient had no respiratory symptoms and was advised to take 50 mg of BENADRYL and LORATIDINE 10 mg daily. It was reported that several years ago she had flu shot and felt chilled and "off" for next several days. It had been "years and years" before receiving another. Last year one had and did well. It was reported that the patient was allergic to NSAID and has stomach upset as medical history. Concomitant medication included ESTRADIOL 2 mg on an unknown date. Treatment for hives not specified included ATARAX 25 mg, 1 tablet, oral, four times a day for 14 days, 56, Refills 1.