Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspnoea, Electrocardiogram abnormal, Eosinophil percentage increased, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: A serious clinical trial report of allergic reaction with bronchospasm has been received from an investigator concerning a 39-year-old male, (subject number 7409052) who is enrolled in study. Medical history included smoking (currently four cigarettes per day) and a ruptured diverticulum with colostomy which was anastomosed eight weeks later in 2005. The subject did not have a history of asthma, lung disease or allergies. He was not allergic to eggs. Concomitant medications included PERCOCET as needed for lower back pain from a previous fall and TYLENOL on 22-Mar-2009 for a toothache. On 24-Mar-2009 at 1159, the subject received a dose of FLUMIST (MEDI3250). On 26-Mar-2009, at approximately 0200, the subject went to emergency room via ambulance complaining that he felt his throat tighten up and had shortness or breath which had been going on for 12 hours adn sharp chest pain which "comes and goes". On physical examination, he was in moderate respiratory distress and had inspiratory and expiratory wheezes and a respiratory rate of 20. He was admitted on 26-Mar-2009 and was treated with intravenous methylprednisolone, nebulizers and IV antibiotics. A computed axial tomography scan showed no evidence of pulmonary embolism and a nonspecific right lower lobe lung nodule not visualized on the prior study. Chest X-ray posterior-anterior and lateral showed no acute parenchymal disease. Blood chemistry was remarkable for a decreased potassium level (3.2 mmol/L). Blood gas results were partial pressure of oxygen 73.8mmHg on 26-Mar-2009 and 65mmHg on 27-Mar-2009, partial pressure of carbon dioxide 40.5mmHg on 26-Mar-2009 and 38mmHg on 27-Mar-2009 and bicarbonate 23.1 mM/L on 26-Mar-2009 and 23.4 mM/L on 27-Mar-2009. The investigator indicated an allergic reaction was the etiology of the event. The subject was discharged on 28-Mar-2009. He was discharged on a prednisone taper and azithromycin. The event of allergic reaction with bronchospasm resolved on 29-Mar-2009 and the subject completely recovered on 02-Apr-2009. The investigator assessed the event of allergic reaction with bronchospasm as possibly related to FLUMIST (MEDI3250). The sponsor also assessed the event of allergic reaction with bronchospasm as possibly related to FLUMIST (MEDI3250). Analysis of Similar Events: A search of the safety database was performed on 08-Apr-2009 for case reports with he preferred terms of "Hypersensitivity," "Type I Hypersensitivity," "Anaphylactic reaction," and "Anaphylactoid reaction." The search yielded twelve case reports of hypersensitivity and four case reports of Anaphylactic reaction after the administration of FLUMIST/CAIV-T. None of the identified cases led to a fatal outcome. Four of these cases were from clinical trials; three of which were assessed as not-related to FLUMIST but rather due to other allergen (SEPTRA, food, and gourds). The fourth case that was assessed as possibly-related to study. The remaining 12 cases were from post-marketing reports, five of which were classified as serious (three spontaneous case reports of anaphylactic reaction, one spontaneous case report of hypersensitivity, and one investigator-initiated trial case report of hypersensitivity. These serious cases are briefly describe below. MEDI-0001207. This spontaneous case involves a 32-year old female who developed an "anaphylactic reaction" characterized by numbness of her tongue, lips and throat, as well as difficulty breathing, approximately 15-20 minutes after receiving FLUMIST. She had a BP of 106/66, pulse rate of 76, and respiratory rate of 16. Lung exam was negative for wheezing. Pulse oximetry was 98% on room air. She was treated with 0.3 ml of epinephrine (1:1000). Patient then felt chest pain and had a sensation that her throat was closing. She was transported to the emergency room where she was treated with BENADRYL and observed for 4-6 hours. She was discharged from the ER on the same day. MEDI-0006112. This is a spontaneous report of an 11-year old male with history of allergy to sulfa drugs, who received FLUMIST and a series of allergy shots (for cat, dog, birch, maple, oak, grass, ragweed, dust, mite, and mold) at the same time. Twenty minutes later, the child had an anaphylactic reaction including tightness of the throat, swollen eyes, hives, wheezing, and sneezing. He was given epinephrine and BENADRYL. The events resolved on the same day. MEDI-0006152. A spontaneous report regarding a 9-year old male who experienced an anaphylaxis reaction, described as wheezing, shortness of breath, facial edema and facial mottling, within 5 minutes of receiving FLUMIST adn VARIVAX vaccines. No additional information regarding treatment or outcome was provided at the time of the report. MEDI-0003849. This spontaneous report involved a 32-year old male who received FLUMIST from a military clinic. Three days later, he developed flea-bite like rashes on his ankles, and had burning pain sensation. He was diagnosed with scabies and was treated with Permethrin cream. The rashes progressed to other parts of his body, accompanied by edema of the forearms, legs, and hands. He was treated with oral prednisone, cetirizine, loratadine, and ranitidine, but no improvement was noted. He was subsequently transferred to a hospital, where micropustules were noted on his knuckles, arms and thigh. A skin biopsy was performed and revealed "acute generalized exanthematous pustulosis." He was treated with triamcinolone body wrap, as well as oral cetirizine, loratadine, and diphenhydramine. Improvements were noted one day after the body wrap was administered. In addition to FLUMIST, the reporter also considered the possibility of drug reaction to the earlier treatments received for the rash as the cause of the reported event. This case from an investigator-initiated trial involved a 34 year-old female patient who complained of tongue numbness and swelling, as well as becoming itchy and splotchy within one hour of FLUMIST vaccination. She was treated with diphenhydramine and the events resolved. The seven non-serious cases presented with typical allergic-reaction type signs and symptoms such as rashes, urticaria, erythema, itching, swelling, numbness, and sweating. Three were reported to have resolved, while outcome was not provided in the remaining four cases. MEDI-0008275 is the only case of hypersensitivity noted in the safety database after the administration of FLUMIST (MEDI3250).