Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Product administered at inappropriate site, Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Concurrent medical conditions included spinal disorder (spinal cord mass that had been there since 2009) and nerve damage (in arms). On 28th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On 28th February 2019, immediately after receiving SHINGRIX and less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain (serious criteria hospitalization) and vaccine administered at inappropriate site. On 8th March 2019, the patient experienced sickness (serious criteria hospitalization), chills (serious criteria hospitalization), sweating (serious criteria hospitalization), burning skin (serious criteria hospitalization), nausea (serious criteria hospitalization) and decreased appetite (serious criteria hospitalization). On 11th March 2019, the patient experienced memory loss (serious criteria hospitalization), behavior abnormal (serious criteria hospitalization), groaning (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), walking difficulty (serious criteria hospitalization), stomach discomfort (serious criteria hospitalization) and irritability (serious criteria hospitalization). On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the sickness, chills, sweating, burning skin, nausea, decreased appetite, memory loss, behavior abnormal, groaning, balance difficulty, walking difficulty, stomach discomfort, irritability, vaccine administered at inappropriate site and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain, sickness, chills, sweating, burning skin, nausea, decreased appetite, memory loss, behavior abnormal, groaning, balance difficulty, walking difficulty, stomach discomfort and irritability to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The patient got her flu shot in her buttocks, to prevent worsening pain or damage to her arms, which led to vaccine administered at inappropriate site. The patient received her dose of SHINGRIX in her right buttock, which led to vaccine administered at inappropriate site. The patient stated the pain from the injection was immediate during the injection and for 3 days afterwards. The patient also noted on Friday, she was sick, nauseated, she could not eat, her skin was burning, she had chills, and then periods of sweat also. The patient stated on Monday the 11th March 2019, her mother came into her room, she did not know her or her sister, her skin was burning, she was yelling, making growling noises, her balance was off, she had difficulty walking and her stomach was hurting also. Emergency medical service was called and the patient was in the hospital from the 11th March 2019 through the 14th March 2019. The patient said she underwent a brain and spine magnetic resonance imaging (MRI) which were negative. The patient said they ran a lot of blood test, did a spinal tap and all were negative. The patient noted she at the time of reporting was not feeling well and saw her neurologist yesterday, who did more blood work. The patient's primary physician, who had been made aware of the issues was not recommending her to get the 2nd dose of SHINGRIX. The reporter had consented follow up. The reporter had provided contact details of the treating physician.