Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site warmth, Malaise, Nausea
Clinical narrative: Shooting jabbing pain from stomach to chest when breathing in or yawning; chest pain while yawning; chest pain while breathing; Headache; weak; clammy; Not feeling well; Bedridden; Fatigue in middle of back; Right arm developed a large rectangle very hot red spot from the top of arm at the injection site to elbow; Right arm developed a large rectangle very hot red spot from the top of arm at the injection site to elbow; Both arms became cold off; Getting pressure behind her head which would come and go intermittently; nausea; Pressure at the center bottom chest area between her breast which became unbearable; breathing difficulty; Belch when she ate or drank water; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number Y2D94, expiry date 30th September 2021) for prophylaxis.   Concurrent medical conditions included fibromyalgia. Concomitant products included omeprazole (Prilosec) and steroids nos (Steroids).   On 12th September 2019, the patient received the 1st dose of Shingrix. On 13th September 2019, 1 days after receiving Shingrix, the patient experienced fatigue, localized erythema, skin warm, coldness of limbs, head pressure, nausea, chest pressure, difficulty breathing, belching and bedridden. On 16th September 2019, the patient experienced weakness, clamminess and feeling unwell. On 28th September 2019, the patient experienced stomach pain, chest pain, painful respiration and headache. On an unknown date, the outcome of the fatigue, localized erythema, skin warm, coldness of limbs, head pressure, nausea, chest pressure, difficulty breathing, belching, weakness, clamminess, feeling unwell, stomach pain, chest pain, painful respiration, bedridden and headache were unknown.   It was unknown if the reporter considered the fatigue, localized erythema, skin warm, coldness of limbs, head pressure, nausea, chest pressure, difficulty breathing, belching, weakness, clamminess, feeling unwell, stomach pain, chest pain, painful respiration, bedridden and headache to be related to Shingrix.  Additional information received were as follows: The day after receiving Shingrix, the patient experienced fatigue in her middle back, her right arm developed a large rectangle very hot red spot from the top of her arm at the injection site to her elbow. The patient's both arms became cold off and on and she started getting pressure behind her head which would come and go intermittently. The patient also experienced nausea and developed pressure at the center bottom chest area between her breast which became unbearable and caused breathing difficulty.  The chest pressure also caused her to belch when she ate or drank water.  On 16 Sep 2019, 4 days after receiving Shingrix,while visiting a family member in the hospital, the patient felt very weak and clammy and not feeling well. The hospitalist and nurse at the hospital advised that she should go to the emergency room. In the emergency room, the patient received an echo cardiogram and blood work, she was also sent to x-ray for a mid back x-ray.  All the tests came back negative.  On 24th September 2019, the patient spoke with her physician and was sent for a frontal chest x-ray which was negative.   On 25th September 2019, the patient saw the physician the day after and was prescribed a steroid and Prilosec. The patient's physician advised for her not to get the second Shingrix injection. The day before reporting date and the day before, 16 days after receiving Shingrix, the patient reported feeling fine in the morning but at about 1pm the symptoms return, it started with the fatigue in her back and spreads to the base of her skull and then to the front of her head. The patient also experienced headache, nausea, coldness in her arms and feeling clammy. The mid chest pressure was still there but her breathing had improved.  The patient reported getting a shooting jabbing pain from her stomach to her chest when breathing in or yawning.  The patient reported that on the reporting date was her last steroid dose which had not helped and was currently taking Prilosec which was not working either.  Previously before the day before the reporting date, the patient was bedridden for most of the days, but the last couple of days she could get up and do her daily activities until afternoon, but had to go back to bed afterwards. The reporter consented to follow up.