Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Lip swelling, Musculoskeletal pain, Nasal oedema
Clinical narrative: Initial information received on 25 September 2012 from a consumer, who is also the patient. A 50-year-old female patient received an initial dose of FLUZONE intradermal, lot number UT4473AA, in the left deltoid at approximately 5:30 PM on 25 September 2012. The patient has a lifelong history of seasonal and food allergies and concomitant medications at the time of injection including CLARINEX, PEPCID, and NASONEX. During administration of the vaccine, the patient noticed it hurt and burned. She felt fine walking to her car and driving home, but approximately one hour after injection her nose began to itch and her upper lip and nostril began to swell. She noticed a small bump at the injection site. The patient has a past medical history of lifelong seasonal and food allergies and reported that she "realized what was happening" and subsequently self-medicated for her symptoms with BENADRYL and PEPCID 40 mg. Her shoulder then began to feel hot and the entire shoulder and upper arm area was red and hot and had a lump about the size of a small egg. The patient applied ice for next two hours. She then felt the roof of her mouth begin to itch and took prednisone 30 mg at approximately 7:15 PM. By about 8:15 PM, the roof of her mouth stopped itching and her nostril swelling had decreased. She called a co-worker who is a physician to advise him of what happened and to make sure she did not need to use her EPIPEN or go to the emergency room. Her shoulder continued to ache and feel hot the rest of the night, and began to subside by noon on 26 September 2012, but was not completely gone. As of 26 September 2012, she still had a red area around the injection site the size of a small egg, but not much of a lump. Her upper lip was still swollen. At the time of this report, the patient had not recovered. Follow-up information received on 28 September 2012 from a consumer, who is also the patient. The patient's lip "was still a bit swollen" as of 27 September 2012, but the swelling was down as of 28 September 2012. The injection site remained tender to the touch but stopped aching on the morning of 28 September 2012. On the night of 27 September 2012, the patient reported having a body temperature of "100" (units not provided). Patient was advised that she might have experienced a biphasic reaction. On the morning of 28 September 2012, the patient remained a bit feverish and self-treated with TYLENOL every 4 hours. The patient experienced achy knees on 27 September 2012 and the patient thought it might be due to the Prednisone. Patient was advised that she might have serum sickness. At the time of this report, the patient had not recovered. Follow-up information received on 04 October 2012 from the consumer, patient reported she had no egg allergy. She had skin allergies and hives since childhood from a variety of food and seasonal triggers. She reported she never had a reaction to the intramuscular (IM) vaccine. The patient stated she did not visit a health care professional because she had all the medications she needed to treat herself at home. She stated she is gradually weaning down off the Prednisone, and her last dose five milligrams (mg) will be taken on 06 October 2012. The patient reported all adverse events resolved. Lip swelling (previously reported as resolved on 28 September 2012), nostril swelling and nose itching resolved on 27 September 2012. Her vaccination site reaction resolved on 28 September 2012. Fever and achy knees which began on 27 September 2012, resolved on 30 September 2012. The patient's outcome was reported as recovered. Follow-up information received on 12 October 2012, confirmed that lip swelling, nostril swelling and nose itching resolved on 27 September 2012. The patient confirmed she had no visit to a healthcare provider and the last dose of prednisone (5mg) was 06 October 2012. The patient confirmed she had no egg allergy. The patient's outcome remained recovered. Follow-up information was received 12 November 2012 from a health care professional who reported that the patient recovered on an unknown date. The reporter had no additional information to provide. List of documents held by sender: vaccination record.