Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Head discomfort, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Tenderness at injection site/Burning sensation when needle went in; Felt like dragged down by a weight/Felt like hit by a bus; Feel very tired, tiredness; Feel shaky; Extreme muscle pain/body blows to his muscles from being so sore; Extreme dizziness; Way off balance, very difficult time standing; way off balance; Nausea, abdominal queasiness; Severe loss of appetite; 99.9% decreased energy; Intense/crushing cranial pressure on brain; body blows to his muscles from being so sore; Extreme difficulty to do anything (get up and move around); This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (received 1st dose of Shingrix in September 2022, refer case US2023AMR003789) and Covid-19 vaccine with an associated reaction of fatigue.   On 9th January 2023, the patient received the 2nd dose of Shingrix. On 9th January 2023, immediately after receiving Shingrix, the patient experienced injection site pain and feeling abnormal. In January 2023, the patient experienced tiredness, tremor, generalized muscle aches, dizziness, difficulty in standing, balance disorder, nausea, appetite lost, energy decreased, head pressure, general body pain and activities of daily living impaired. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, feeling abnormal, tiredness, tremor, generalized muscle aches, dizziness, difficulty in standing, balance disorder, nausea, appetite lost, energy decreased and general body pain were recovering/resolving and the outcome of the head pressure and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, feeling abnormal, tiredness, tremor, generalized muscle aches, dizziness, difficulty in standing, balance disorder, nausea, appetite lost, energy decreased, head pressure, general body pain and activities of daily living impaired to be related to Shingrix.  Linked case(s) involving the same patient:US2023AMR003789   Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The patient reported that he received Shingrix injection in his left arm.  The patient stated that about an hour after he received the injection, he felt like he was being dragged down by a weight.  The patient stated that later that night, he began to feel very tired throughout the evening.  The patient stated that when he woke up this morning (reporting day), the side effects were becoming severe.  He stated that when he tried to get up this morning, he had extreme difficulty trying to do anything.  The patient stated that he began to feel shaky, had extreme muscle pain from head to toe and experienced extreme dizziness to where he was way off balance and had a very difficult time standing.  The patient also stated that he experienced nausea, severe loss of appetite, abdominal queasiness, and 99.9 percent decreased energy and tiredness.  The patient described having crushed cranial pressure on the brain.  The patient described that he felt like he was having body blown to his muscles from being so sore and he described the feeling that he felt like he was hit by a bus.  The patient also noted that when he received the Shingrix injection, he felt a burning sensation when the needle went in. However, he stated that aside from tenderness, there was no reaction at the injection site.  The patient stated that if he had health issues, he did not think he would have survived.  The patient stated he was improving little by little, but still did not want to get up and move around and was still having intense cranial pressure.  No additional adverse event information provided.; Sender's Comments:  US-GSK-US2023AMR003789:Same reporter