Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, General physical health deterioration, Headache, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 50-year-old female patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine (Flu vaccination without any reaction). Concurrent medical conditions included hypothyroidism. Concomitant products included Vitamin D3, spironolactone and ARMOUR THYROID. On 11th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 12th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site tenderness, injection site swelling, injection site erythema, injection site induration and fatigue. On 13th October 2016, the patient experienced nausea, headache, vertigo and general physical health deterioration. On an unknown date, the outcome of the injection site tenderness, injection site swelling, fatigue and headache were recovering/resolving and the outcome of the injection site erythema, injection site induration, nausea and vertigo were recovered/resolved and the outcome of the general physical health deterioration was unknown. The reporter considered the injection site tenderness, injection site swelling, injection site erythema, injection site induration, fatigue, nausea, headache, vertigo and general physical health deterioration to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient had receive the flu vaccine for years without any reaction. The reporter stated that she was administered a dose of FLUARIX QUADRIVALENT after 6 PM on left deltoid. The next day, about 24 hours later, the patient came back from a run, and her daughter noticed that her arm was red and swollen around the injection site. The patient had a hard lump directly at the injection site, and the redness and swelling extended beyond the lump, but did not leave her upper arm. Her arm was also a little sore, and she felt fatigued so she went to bed. On 13th October 2016, the patient woke up and still felt fatigued and her arm had really started hurting, Around noon the patient stated going downhill. The patient experienced extreme vertigo accompanied by nausea. The fatigue had become extreme and she had a headache. The symptoms were so bad that when the patient contacted her health care professional they sent her to the emergency room, where the patient got treatment. The patient started improving after the visit to the emergency room and was sent home that evening. During the night the patient started feeling better, but would get some vertigo and nausea if she moved her head. At the time of reporting the patient was feeling much better. The patient still had some fatigue and a headache, but the vertigo and nausea have resolved. The lump at the injection site had gone away over the course of the day. There was still a little swelling and tenderness at the injection site, but it was much improved compared to day before. It was thought by the patient's health care professional and the emergency room physicians that this was a reaction to the vaccine. It was also thought the nausea was caused by the vertigo.