Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Bone pain, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bone pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (on 11th April 2018, vaccinated with the first dose (refer case US2018GSK163698)). On 22nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 23rd August 2018, the patient experienced pain in arm. On 25th August 2018, the patient experienced chills, tiredness and feeling abnormal. On 27th August 2018, the patient experienced bone pain, queasy, neck pain, back pain and general body pain. The patient was treated with paracetamol (Tylenol) and atropa belladonna (Belladona). On an unknown date, the outcome of the bone pain, chills, neck pain, back pain, feeling abnormal and general body pain were recovered/resolved and the outcome of the influenza-like symptoms was recovering/resolving and the outcome of the pain in arm was resolved with sequelae and the outcome of the queasy was not recovered/not resolved and the outcome of the tiredness was unknown. It was unknown if the reporter considered the bone pain, influenza-like symptoms, chills, pain in arm, queasy, tiredness, neck pain, back pain, feeling abnormal and general body pain to be related to SHINGRIX. Additional information was reported as follows: On 22nd August 2018 around 3 pm, the patient was vaccinated with her 2nd dose on the left arm. On 23rd August 2018, the next day after vaccination the patient experienced soreness in her arm. In August 2018, the weekend following the vaccination the patient started to begin feeling like she had flu. On 25th August 2018 Saturday, the patient felt tired, had chills, and just didn't felt like herself. However on 26th August 2018 Sunday, the patient felt pretty good. On 27th August 2018 Monday, the patient was able to run errands as usual but she had a queasy stomach. On 28th August 2018 Tuesday, she had a queasy stomach, apart from it chills started again, she experienced bone aching which also included back pain and neck pain and on the same day she again felt like she had flu. The patient also checked her body temperature, which that it was normal. On 28th August 2018, the patient called her healthcare professional and he suggested to take Tylenol as it was needed and also to make sure that she was hydrated as it sounds like it could be reacting to the SHINGRIX shot. On 29th August 2018 Wednesday later that night, the patient's stomach remained queasy. The patient stated that the queasiness experienced by her was not diarrhea but food goes right through her and she goes about 4 to 5 times a day. On the morning of reporting, the patient called her healthcare professional again and he recommended her to go to a clinic. On the day of reporting, the patient started using an expired Belladonna medicine at 9 am and again at 13 pm. At the time of reporting the patient's stomach was feeling better. The patient had carried out her blood work and her annual physical before receiving the 2nd dose of SHINGRIX that showed normal results. The patient reported these adverse events to the pharmacy and her doctor's office. No further information was provided.