Age: 43.0
Sex: F
Vaccine: FLUR3
Symptoms: Lip swelling, Palpitations, Pharyngeal oedema, Rash, Swollen tongue
Clinical narrative: This is an initial report of a serious adverse event, received on 06/Dec/2013, following receipt of FLUBLOK. Subject, 43 year old, 230 lb, 64 inch, female received FLUBLOK Intramuscular on 03/Dec/2013. She was vaccinated at community hospital and her provider informed her that he/she administered FLUBLOK lot #340503F. The dose of FLUBLOK administered was obtained from another hospital. No information on the method of transport of the vaccine was provided. The patient self-reported the event to the Protein Sciences website. On or about Day 0 of receiving FLUBLOK - 03/Dec/2013 at approximately 7:00 PM -- the subject reported experiencing swelling of the eyes, lips, tongue and throat, a headache, increased blood pressure, rash above the right eye, difficulty breathing and "racing" of the heart. Prior to receiving FLUBLOK, the patient reported that she took two BENADRYL capsules to prevent or lessen any allergic reaction she might have. The patient also reported experiencing anxiety and a racing heart prior to receiving the influenza vaccination. The patient reported that this was the first flu vaccine she had ever received, due to the fact that she is highly allergic" to eggs. Within minutes of receiving the vaccination the patient's tongue felt swollen, a few hours later she developed a headache but continued to work. Near the end of her shift at work she took two TAGAMET as recommended by the staff nursing supervisor at her place of employment. After leaving work and arriving at home on 4/Dec/2013, the patient took two more BENADRYL and she reports she felt miserable with a racing heart and increased blood pressure. At 3:00 PM on 4/Dec/2013, the patient noticed a rash above her right eye and her eyes, lips and tongue appeared very swollen. She began having difficulty breathing on her way into work on 4/Dec/2013 which caused her to use her inhaler (condition for which the inhaler was prescribed was not reported). Upon her arrival at work, a staff member recommended that she go to the emergency room. In the emergency room the patient received intravenous SOLUMEDROL, ZYRTEC, a breathing treatment, and intravenous fluid bolus (doses not reported). When her throat improved, she was treated with ibuprofen. At the request of her nursing supervisor, the patient did not go home alone, but stayed in a vacant hospital room overnight for observation. On the morning of 5/Dec/2013, the patient reported that she had improved, but still felt swollen so she returned to the emergency room before returning home. In the emergency room, the patient was given prescriptions for an EPI-PEN and prednisone taper. She was instructed to continue taking ZYRTEC and to use BENADRYL and TAGAMET if needed for a flare of the reaction. The patient followed up with her primary healthcare physician on 10/Dec/2013. It was reported at that time all of the events had resolved except that her tongue remained slightly swollen. The primary health care physician prescribed another five day course of prednisone which the patient reports completing on 14/Dec/2013 and 15/Dec/2013. At the time of this report, the patient reported that her tongue remains slightly swollen. She plans to follow-up with her primary healthcare physician. Medical/surgical history reported a severe allergy to eggs. Illnesses at the time of vaccination were not reported. Laboratory and/or other relevant test results were not reported. Concomitant medications were not reported. The events are considered serious as they are significant medical events that caused the patient to visit an emergency room for symptomatic treatment and unexpected, based on the FLUBLOK Package Insert. Further medical follow-up information is unavailable at the time of this report. This report was received from a consumer therefore; no medical confirmation or assessment of causality is available.