Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Malaise, Pain, Pyrexia, Tremor
Clinical narrative: soreness at the injections site/Burning at injection site  at the time of vaccination; second dose 03MAR2022, first 2 years ago; Fever/ around 5 am fever of 100-100.5 degree F; flu like body aches and pain; flu like body aches; felt like he was in a car wreck; help him to sleep; Chills; Uncontrollable Shaking; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included testosterone (Testosterone Injection) for product used for unknown indication.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose approximately 2 years ago and had body aches and pain, refer case US2022AMR045422). Concurrent medical conditions included myopathy.   On 3rd March 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd March 2022, the patient started Testosterone Injection .5 ml at an unknown frequency. On 3rd March 2022, immediately after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too long. In March 2022, the patient experienced malaise and sleeplessness. In March 2022, the patient experienced fever, chills, pain and flu-like aching. In March 2022, the patient experienced tremor. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. In March 2022, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the fever, chills, tremor, pain and flu-like aching were recovered/resolved and the outcome of the malaise, sleeplessness and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site pain, fever, chills, tremor, pain, flu-like aching, malaise and sleeplessness to be related to Shingrix.     Additional details were provided as follows: The patient received a dose of Shingrix in left deltoid later than the recommended interval, which led to lengthening of vaccination schedule. The patient felt burning at the injections site at the time of vaccination. The patient stated that he did not received any other shots that day, but he did received 0.5ml of injectable Testosterone the day before he received his Shingrix shot. 10 hours after receiving the vaccination, at around 1 am, the patient experienced soreness at the injections site, flu like body aches and pain, fever and chills. The patient stated he took Tylenol no 3 to help with the pain and to help him sleep. 14 hours after receiving the vaccination, at around 5 am, the patient experienced uncontrollable shaking and chills and had a fever of 100 to 100.5 degrees F. The patient said that it was very scary, and he had never shooked like that before in his life and was unable to take his temperature, but was basing the temperature he stated on prior experiences of fever. The patient stated that the shaking and chills subsided after 1 hour, but he had to turn the heat up in his house, put on warmer clothes, and ate some yogurt. The body aches and pain lasted another day and a half but he felt like he was in a car wreck less than a week after receiving the vaccination. The patient stated that for the type of MS he had more prone to pain than the average population, and he experienced more than average muscle pain for average activity. The patient provided limited information (unknown lot and expiration date). The reporter consented to follow-up with health care professional (Pharmacy). It was unknown if the reporter considered the injection site pain, fever, chills, tremor, pain, flu-like aching, malaise and sleeplessness to be related to Testosterone injection.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR045422:Same patient, same reporter