Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2014US000925 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (reference number: 508024) website on 06 Jan 2014: This report refers to a 28-year-old female patient. Her medical history included allergies to penicillin, sulfa, WELLBUTRIN, Bupropion, CELEXA; Health Conditions: bipolar, depression, generalized anxiety disorder, panic with agoraphobia, social phobia, features of OCD, asthma, reflux, carpal tunnel (left wrist) and periarthritis in foot/ankle. This polymedicated patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in to the left arm on 26 Sep 2013. Within 10 minutes of getting flu shot, the site itched really badly, she thought it may have been from the Band Aid as she was latex sensitive (although latex had not ever affected her that quickly). She removed the Band Aid at the time itching started. The place where she got the vaccine was about a one and a half to two hour drive from her home. By the time she reached home late that afternoon, she had a swollen large egg shaped red mark below the injection site. She did not think much of it, but had never had this before. Within 48 hours later, the swelling had spread to 3 inches below the injection site and 4 1/4 inches going backwards on her arm from where it had started. Within 72 hours, it spread to 3 inches down from the injection site and 5 inches around the arm. She had a flu shot on a Thursday and on Saturday her mother called the pharmacy to report the symptoms and see if it was normal. The pharmacist said they had never heard of it getting that large and swelling to that extreme and said to put ice on it and to seek medical attention, if the reaction was not better the next day. After the mother spoke with the pharmacist, they visited a couple pharmacies and showed the reaction. They were advised to try ice as much as the patient was comfortable with and to seek medical attention by noon Sunday if no improvement was seen. She only had occasional itching and burning prior to icing the site, but after starting to ice it, she noticed that when the ice was removed from the arm, the itching came back and was almost unbearable. When the ice was put back on, the itching reduced a bit. By 10-11 am on Sunday, the itching was really bad, so she went to ER. The doctor said it was a localized reaction. She was advised to take BENADRYL orally. She told the doctor that she took BENADRYL orally for years due to seasonal allergies and was doing so and it did not help the flu shot reaction. The doctor advised to use topical BENADRYL and ice the affected area 20 minutes on and 20 minutes off. She also had a bruise that was nowhere near the injection site and it went around her arm and was a couple inches long. It was exactly 3 weeks and 1 day at the time of reporting, since she had the flu shot, and she still had a huge mark on her arm and also until about 1 week ago she still experienced some itching. She still got occasional itching, but nothing severe. Final outcome of the events was reported as condition unchanged as on 18 Oct 2013. No further information about seriousness and causality was provided.