Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Neurological examination normal, Pain in extremity, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: This case was reported by a non-health professional and described the occurrence of leg pain in a 9-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 795Z7, expiry date 30th June 2018). On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced leg pain and back pain. On an unknown date, the outcome of the leg pain and back pain were unknown. It was unknown if the reporter considered the leg pain and back pain to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: No health care professional information provided. The FLULAVAL QUADRIVALENT was administered to an 8 or 9 year old patient. After received FLULAVAL QUADRIVALENT, the patient experienced leg and back pain. On 30th November 2017, the patient visited an endocrinologist and was back at the doctor's office. GlaxoSmithKline representative stated that she will call back with more detailed information after the doctor's visit today. No additional information provided. Follow up information received from the physician via sales representative on 4th December 2017: The patient's demographic details were updated. The patient's past medical history included lack of weight gain. On 15th November 2017, the patient received FLULAVAL QUADRIVALENT (batch number updated). In November 2017, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced middle to upper back pain and bilateral leg pain starting at thigh and going down to ankle unrelieved from over the counter medications. Pain rated as 5 on scale of 1 to 10. In 2017, less than a month after receiving FLULAVAL QUADRIVALENT, the patient experienced hobbling and decrease in leg strength due to pain. The patient did not experience numbness or tingling and reflex was normal. The batch number reported for FLULAVAL QUADRIVALENT (975Z7) did not exist and was updated to 795Z7 as per sales database. Bilateral leg pain and acute middle to upper back pain were not recovered. The outcome of hobbling and decrease in leg strength due to pain were unknown. The emergency or physician visit was required. It was unknown if the reporter considered the leg pain, acute back pain, walking difficulty and lower extremities weakness of to be related to FLULAVAL QUADRIVALENT. Follow up information received from physician on 16th January 2018: The patient demographics were updated. The patient experienced acute back pain which resolved after 2 weeks and bilateral moderate to severe leg pain which was lasting up till the time of reporting. The patient had no fever, no joint pain, swelling and neuromuscular weakness. On 5th December 2017, the patient experienced systemic inflammatory reaction. From 5th December 2017 to 7th December 2017, the patient was admitted to the hospital for work up. The abnormal lab test was elevated sedimentation rate of 28 to 48 on 3 occasions. The neurology comment showed no neuro concerns. The rheumatology consul showed ASO (Antistreptolysin O) and rheumatoid factor and C3 (not further specified) within normal. The outcome of the bilateral moderate to severe leg pain and walking difficulty was not resolved. The reporter suspected it to be a secondary to systemic inflammatory reaction from flu vaccine. The patient was taking NSAIDs (non-steroidal anti-inflammatory drugs) and still had pain. It was unknown if the reporter considered systemic inflammatory reaction to be related to FLULAVAL QUADRIVALENT. The VAERS details were updated.