Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Nausea, Reaction to preservatives
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received Influenza vaccine Quadrivalent for prophylaxis. Concurrent medical conditions included splenectomy and idiopathic thrombocytopenic purpura. Concomitant products included TYLENOL. On an unknown date, the patient received Influenza vaccine Quadrivalent (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach to be related to Influenza vaccine Quadrivalent. Additional details reported as follows: The age at vaccination was not reported. The reporter approximates that within the past five years there were three yearly occasions in which the symptoms occurred within a few hours after receiving a flu vaccine of unknown name and manufacturer. The patient always had the vaccines administered into her left arm muscle, as she was right-handed. The patient cannot recall exact dosing details. The left arm would be swollen and red around the site of injection, and the area would be 4 inches or greater in diameter. That arm area was painful and would feel hot like it had a fever. The symptoms would last for another day and then resolve. In addition to the left arm symptoms, she also felt sick to her stomach described as feeling like she was getting the flu on one of the three occasions. That symptom diminished the next day after receiving the vaccine. The patient went to the doctor the day after receiving the vaccine when she had the stomach upset. The doctor told her that symptom was likely to have been caused by food poisoning instead of the flu. Once she changed and started getting her annual flu shot at a different retail pharmacy location, she did not have these symptoms and was told that the previous symptoms which had followed her previous flu vaccinations had been due to the preservatives in the vaccine products she had previously received which were no longer now included in the vaccine provided at the retail location. The patient thought the symptoms were due to the preservatives in those past flu vaccine products. This case was linked with case US2018082725 and US2018GSK089039, reported by the same reporter. Follow up information received from consumer on 21st June 2018: The reporter have consent to contact her physician and provided details for the same. The age at vaccination was not reported. The patient's general practitioner was not aware of the issue that the patient had with the past flu vaccines that patient received through hospital. The issue was the preservative in the vaccine. Once the patient called pharmacy for the shot the issue was mostly resolved since they use a non preservative product. Sender's Comments: US2018GSK089040: Previous VAERS submission in paper format