Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Flushing, Injection site bruising, Injection site induration, Injection site mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number M73CE, expiry date 30th June 2019) for prophylaxis. Concurrent medical conditions included fruit allergy (berries) and drug allergy (rocephin and penicillin). On 11th September 2018, the patient received the 1st dose of FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 11th September 2018, less than an hour after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site swelling, injection site itching, injection site wheal, injection site bruising, injection site lump, injection site induration, flushing and extremities hot feeling of. In September 2018, the patient experienced tongue thick, skin tightness, ocular discomfort, wheezing and nasal congestion. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the injection site swelling and injection site bruising were recovering/resolving and the outcome of the injection site itching, injection site wheal, injection site lump and injection site induration were recovered/resolved and the outcome of the tongue thick, skin tightness, ocular discomfort, wheezing, nasal congestion, flushing and extremities hot feeling of were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site wheal, tongue thick, injection site bruising, skin tightness, ocular discomfort, wheezing, nasal congestion, injection site lump, injection site induration, flushing and extremities hot feeling of to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The case was previously reported to a doctor. The patient received FLUARIX QUADRIVALENT 2018-2019 season on the right deltoid. The Patient stated that within 10 minutes of receiving vaccine, she experienced swelling, itching, and welts at the injection site.  The patient stated that she also felt flushing or hotness in both arms and later that evening, she noticed a bruise (4 inches wide by 3 inches length) at the injection site. The patient stated that within 10 minutes of vaccine, she had a hard knot underneath her skin at the injection site that was like a golf ball. The patient stated that she went to the emergency room within 30 minutes following the injection.  The patient stated that she was prescribed Benadryl, prednisone and hydroxypropionate to took at home. The patient stated that whenever it was time for her to took prednisone, right before she took the medication, her face and eyes felt tight. The patient stated that if she did not take the antihistamine, her tongue feels thicker, she experienced wheezing and her nose felt congested. The patient stated that she would went to an allergist later on the reporting day. The patient stated that when it was time to took the medication, she also felt flushing in both arms between the wrists and the shoulders. The contact details of the physician was reported.