Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site discomfort, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of streptococcal sore throat in a 35-year-old female patient who received FLULAVAL QUADRIVALENT. On 2nd November 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (subcutaneous). On 2nd November 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced bursitis, injection site cyst, joint pain, numbness, tingling, injected limb mobility decreased, burning sensation, injection site pain and intramuscular formulation administered by other route. On 5th January 2017, the patient experienced streptococcal sore throat and nausea. In January 2017, the patient experienced gastrointestinal disorder and diarrhea. The patient was treated with diclofenac, CELEBREX and MEDROL. On an unknown date, the outcome of the streptococcal sore throat was recovering/resolving and the outcome of the bursitis, injection site cyst, injected limb mobility decreased, burning sensation, gastrointestinal disorder, diarrhea, nausea, injection site pain and intramuscular formulation administered by other route were unknown and the outcome of the joint pain, numbness and tingling were unchanged. The reporter considered the streptococcal sore throat, bursitis, injection site cyst, joint pain, numbness and tingling to be related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the injected limb mobility decreased, burning sensation, gastrointestinal disorder, diarrhea, nausea and injection site pain to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The patient never had any injury or any medical problems before. The patient received the vaccine subcutaneously, which lead to incorrect route of vaccination. When the patient received the vaccine shot in left arm it hurt so bad. Ever since that shot, patient experienced pain in my joint, limited range of motion, burning in my arm, numbness in my wrist, tingling and numbness in my fingertips. The patient had joint pain all the time with every movement, unbearable point in shoulder joint, unbearable burning pain in deltoids. X-ray was performed and MRI (magnetic resonance imaging) showed mild to moderate bursitis and tiny cysts in lesser tuberosity of the humerus one month after vaccination. The patient had trouble ever since flu shot was administered and felt like there was something wrong with me all over, sensation in my feet, legs and in my other arm. She felt like a tingly feeling in both legs and arms which was new since vaccination. She had been seen by my PCP (physician), an orthopedist, and a chiropractor. That past week at chiropractor visit she received therapy ultrasound on my shoulder by a nurse when she directed the therapy at a certain spot that was a new pain in that area. She was diagnosed with strep throat on February 18 (around that date). She was given diclofenac and experienced nausea while taking it and when it ran out that was when she got strep throat, right after she stopped taking diclofenac. The patient went to amusement park and her family was sharing water and she was the only one who ended up with strep throat. Patient also experienced GI (gastrointestinal) problems, specifically diarrhea and nausea. The orthopedic physician directed her to stop diclofenac and start taking CELEBREX which she took for three or four days but then experienced nausea again, so stopped CELEBREX. Patient was referred to manufacturer of diclofenac and CELEBREX. The patient suspected maladministration.