Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Eye swelling, Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 6-year-old female patient who received FLUARIX QUADRIVALENT (batch number 572KT, expiry date 26th May 2018). Co-suspect products included ZANTAC unknown for an unknown indication and BENADRYL for an unknown indication. On 27th January 2018, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, the patient started ZANTAC at an unknown dose and frequency and BENADRYL at an unknown dose and frequency. On 28th January 2018, 1 days after receiving FLUARIX QUADRIVALENT and not applicable after starting ZANTAC, the patient experienced injection site pain and injection site swelling. On 3rd February 2018, the patient experienced hives. On 7th February 2018, the patient experienced fever. In February 2018, the patient experienced upset stomach, facial swelling, eye swelling, feeling hot and overdose. The patient was treated with ZYRTEC. The action taken with ZANTAC was unknown (Dechallenge was unknown). Rechallenge with ZANTAC was unknown. The action taken with Benadryl was unknown (Dechallenge was unknown). Rechallenge with BENADRYL was unknown. On an unknown date, the outcome of the hives and upset stomach were not recovered/not resolved and the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the fever was recovering/resolving and the outcome of the facial swelling, eye swelling, feeling hot and overdose were unknown. The reporter considered the hives, fever, injection site swelling, facial swelling and eye swelling to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the upset stomach and feeling hot to be related to FLUARIX QUADRIVALENT. The reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. The reporter considered the upset stomach to be possibly related to ZANTAC. It was unknown if the reporter considered the fever and feeling hot to be related to ZANTAC. Additional details were reported as follows: This case was reported by the patient's mother. The patient received FLUARIX QUADRIVALENT in right deltoid at 14:30. The next day, the patient's her entire deltoid was swollen and sore. BENADRYL cream was rubbed on the patient's arm and the symptoms were resolved after a couple of days. After 7 days of vaccination, the patient developed hives, mostly of her scalp, forehead and behind her ears. On 4th February 2018, the hives spread to her shoulders and back. On 5th February 2018, the hives had spread to cover her entire back. The hives continued to get worse each day, and had been moving around. For example her back cleared up, but her face swelled to the point that her eyes were almost swollen shut. She did not had any problems with her airways. She saw the pediatrician on 5th February 2018 and on 7th February 2018. She visited an allergist on 7th February 2018. The hives were hot to the touch, but no fever was documented until 7th February 2018, when she had a temperature of 102 degree C. After seeing the allergist, she was now taking large doses of BENADRYL, ZYRTEC and ZANTAC. The reporter mentioned that, the patient was taking doses 4 to 6 times the on the counter (OTC) dose for BENADRYL and ZANTAC, which led to overdose and it caused her daughter to have an upset stomach. The patient's fever was down to 100.8 and the swelling in her face was decreased. She was now able to open her eyes and move her eyebrows, though there was still swelling below her eyes. At the time of report, the hives are mostly on her arms, hands, legs and feet, though not the palms of her hands or soles of her feet. The reporter described it like the hives were moving from top to bottom and back to front down her daughter's body. The patient required emergency visit. The reporter considered the upset stomach to be possibly related to BENADRYL. It was unknown if the reporter considered the fever and feeling hot to be related to BENADRYL.