Report A0371557A describes a severe allergic reaction in a 53 year old female who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix). The vaccinee had no known drug allergies and had not experienced any adverse events following previous vaccinations. on 6/12/02, around 11:30, the vaccinee received her first injection of Twinrix (lot HAB218B6; expiration date 12/11/03) as part of a work up for fatty liver. She was, apparently, antibody negative for hepatitis. Within on hour, the vaccinee telephoned the physician's office and reported that she had mild shortness of breath and felt as though her face was sunburned. She reportedly attributed these symptoms to anxiety. During the telephone conversation, she reported that her face was flushed. This erythema subsequently spread to include, in sequence, the upper and lower extremities, and became pruritic. She was advised to go to the emergency room, and she started to drive herself there. A couple of blocks from the hospital, she started developing shortness of breath and a severe persistent cough. She broke out in hives, and she almost felt like she was sunburned. She did not feel that her tongue was enlarged or swollen, but did feel like there was a lump in her throat. Her voice was hoarser than normal. She was almost constantly coughing. She stated she did have a mild cough prior to this, but stated that it was much worse. She did not have any nausea or vomiting. She felt like she had some swelling around her eyes. At the emergency room, her temperature was 99 degrees F, pulse 119 beats/minute, respiratory rate 26 breaths/minute, blood pressure 194/97 mm Hg. The emergency room stated that the patient was in obvious distress. She is constantly coughing. She is congested and wheezing. She is very erythematous. She had mild per-orbital edema on examination. Examination of the lungs revealed diminished breath sounds throughout. She sounds tight. Hives with erythema were observed on her extremities, back and abdomen. Her face was erythematous. Oxygen saturation on room air was 96%. She was administered 2 liters oxygen/minute and her oxygen saturation increased to 98%. Chest x-ray taken on 6/12/02 revealed hypoinflation and bibasilar atelectasis. The emergency room physician made a diagnosis of severe allergic reaction. The vaccinee was treated with intravenous diphenhydramine 50 mg. She was observed in the emergency department for over 2.5 hours and did greatly improve. By 15:00 she was very much better. Her voice was back to normal. She was able to take sips of water. She no longer had a cough. On repeat lung examination, she still had slightly diminished breath sounds, but there was no wheezing at that time. Her lungs were much more open. She stated that she still had a mild feeling like a lump in her throat, but stated she felt this way when she gets a cold and she had begun feeling that way prior to the allergic reaction. The patient was discharged from the emergency room. She was given a prescription for prednisone and an Epipen and was told to buy over the counter benadryl and pepcid and take these through the next few days. Her symptoms resolved as of 6/12/02. The reporter stated that the allergic reactionwas not related to Twinrix; however, the Twinrix immunization series was discontinued. The vaccine provider considered the events to be life-threatening.