Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Burning sensation, Inappropriate schedule of product administration, Myalgia, Pain, Paraesthesia
Clinical narrative: Drug dose administration interval too short; Intense burning sensation in all extremities (both hands and feet); Tingling; Described the pain as 'internal burning and felt like muscles were on fire'; This case was reported by a pharmacist via sales rep and described the occurrence of burning sensation in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis and cyanocobalamin (Vitamin B12 Injection) solution for injection for an unknown indication.   The patient's past medical history included pain, numbness and mixed sensory & motor neuropathy (in both feet). Previously administered products included Gabapentin (couldn't tolerate it) and Norco. Concurrent medical conditions included diabetes.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th October 2019, the patient received the 2nd dose of Shingrix. On 11th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, the patient started Vitamin B12 Injection at an unknown dose and frequency. On an unknown date, less than 3 months after receiving Shingrix, Fluarix Quadrivalent 2019-2020 season and Vitamin B12 Injection and not applicable after receiving Shingrix, the patient experienced burning sensation, tingling, pain and drug dose administration interval too short. The patient was treated with hydrocodone bitartrate + paracetamol (Norco). On an unknown date, the outcome of the burning sensation, tingling and pain were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the burning sensation, tingling and pain to be related to Shingrix, Fluarix Quadrivalent 2019-2020 season and Vitamin B12 Injection.  Additional details were provided as follows: The health care professional asked whether there had been any report of patient getting a mild version of shingles after receiving Shingrix. The patient received Fluarix in the left deltoid and Vitamin B 12 injection in the right deltoid. The patient reported tingling, intense internal burning sensation in all extremities(both hands and feet) and felt like her muscle were on fire. The patient thought that was due to the Shingrix and rated the pain as a 9/10 which lasted for 1 and a half day. On 3rd October 2019, the patient thought she should get 2nd dose of Shingrix. The patient had Norco at home and took some. The patient said that the pain lasted 1 and a half days and described the pain as internal burning and felt like her muscles were on fire. On 13th October 2019, the patient received 2nd dose of Shingrix which was earlier than the recommended schedule, which led to drug dose interval too short. The Health care professional assumed everything was alright. The reporter agreed to follow-up by GlaxoSmithKline.