Age: 75.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Heart rate increased, Hernia, Hypertension, Injection site pain, Insomnia
Clinical narrative: Arm hurt at the site of injection; Hurt, high up on shoulder in muscle; Pain spread to neck, right side, can't hold straight; Feels tight; Pain keeps him up at night, can't sleep; Cardiac effects, tachycardia/He said he can feel a feeling in his chest; Blood pressure elevated/when the pain shoots up his blood pressure goes up but this comes and goes; Pain is debilitating; Not really sharp in morning; Headache; Nauseous; Double hernia; sciatic; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   Previously administered products included COVID-19 Vaccine (received 1st dose on an unknown date and had a reaction was flat on his back) and COVID-19 Vaccine (received 2nd dose on an unknown date and stated not as bad). Concomitant products included COVID-19 VACCINE.   On 7th July 2022, the patient received the 1st dose of Shingrix and TETANUS VACCINE. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, shoulder pain, neck pain, stiffness, sleeplessness, tachycardia, blood pressure high, weakness, feeling abnormal, headache, nausea, hernia, sciatica and muscle pain. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Physical Therapy). On an unknown date, the outcome of the injection site pain, shoulder pain and nausea were not recovered/not resolved and the outcome of the neck pain, stiffness, sleeplessness, tachycardia, blood pressure high, weakness, feeling abnormal, headache, hernia, sciatica and muscle pain were unknown.   The reporter considered the injection site pain, shoulder pain, neck pain, stiffness, sleeplessness, tachycardia, blood pressure high, weakness, feeling abnormal, headache, nausea, hernia, sciatica and muscle pain to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 19-Sep-2022 Reporter's Comments: The case was self reported by the patient. The reporter did not have the lot number of the Shingrix so reporter provided the information from the pharmacy where patient got the shot. The patient received a dose of Shingrix into right arm and within a few days of 07th July 2022 the Tetanus vaccinated arm felt okay but the Shingrix shot, not okay, it still hurt at the site of the injection.  The patient thought he/she would give it some more time. Even towards the end of the month, it was still annoying to the patient.  The patient reported that It was high up on the shoulder, in the muscle and then in August (unspecified year) something happened that he/she thought was unusual. The pain began to spread up the top of his/her shoulder to base point of his/her neck on the right side and a little behind it and it had been painful like that now till he/she seen to PCP (primary care physician) a week and a half ago and the patient was referred to a physical therapist.  The reporter reported that he/she had been going to physical therapy. The patient had first appointment and it did not seem to be helping. The only thing that seemed to helping his/her was Tylenol and ice located on back toward the top of shoulder and down the radiation to the arm just below to the arm just below the top of the arm. Not to the elbow or wrist.  The patient stated his physical therapist stated the patient felt tight.  The patient stated that the pain kept him up at night and indicated that if he did not sleep on ice then he could not sleep.  The patient said the pain was so bad he could not hold his head (neck) up straight some times during the day and he had never experienced anything like this before. The patient also indicated that the pain was causing some cardiac effects (tachycardia).  The patient could felt feeling in his chest and said normally his heart rate/pulse was below 70 but he had seen it shoot up to 95 or 98 or 107 and also his blood pressure had been elevated when the pain shoots up his blood pressure gone up but this comes and goes. The patient never experienced anything like this day in and day out and he did not think his pain was related to Shingrix.  The patient clarified that he thought it was a rotator cuff issue but he did not think that was the case because he had full range of motion in the arm and his strength and ability to squeeze was not affected/was good. It was just the pain. The neck/shoulder pain was debilitating.  The patient said he was in a lot of pain during certain times of the day.  The reporter said that he was reading about possible side effects of Shingrix and that there were some he could related to he stated, in the morning when he woke up he was not really sharp and he felt a headache and he was slightly nauseous. The patient stated that not enough to keep me from eating or drinking. No vomiting. The patient stated he was slightly nauseous right now. The patient had double hernia and had sciatic epidural.  The patient had gone to the doctor more times this year than the past 5 years all together. It was unknown if the reporter considered the injection site pain, shoulder pain, neck pain,stiffness, sleeplessness, tachycardia, blood pressure high, weakness, feeling abnormal, headache, nausea, hernia and sciatica to be related to Tetanus vaccine.