Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash macular, Rash pruritic, Skin ulcer
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu vaccine for prophylaxis and SHINGRIX for prophylaxis. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and Flu vaccine (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 9th November 2018, 211 days after receiving SHINGRIX and Flu vaccine and not applicable after receiving SHINGRIX, the patient experienced pain in extremity and burning sensation. On 14th November 2018, the patient experienced itchy rash and rash. In November 2018, the patient experienced hemorrhage (serious criteria GSK medically significant). On 16th November 2018, the patient experienced erythromacular rash. On an unknown date, the patient experienced skin ulcer and incomplete course of vaccination. The patient was treated with BENADRYL and Cortisone. On an unknown date, the outcome of the hemorrhage was recovered/resolved and the outcome of the pain in extremity, erythromacular rash and skin ulcer were not recovered/not resolved and the outcome of the burning sensation, itchy rash, rash and incomplete course of vaccination were unknown. It was unknown if the reporter considered the hemorrhage, pain in extremity, erythromacular rash, skin ulcer, burning sensation, itchy rash and rash to be related to SHINGRIX and Flu vaccine. Additional details were provided as follows: The reporter stated that she received SHINGRIX and flu shot (unknown manufacturer) on unknown arm. On 12th October 2018, the patient was due for the 2nd dose and she has not yet received the 2nd dose, which led to incomplete course of vaccination. The patient stated that she did not know that she needed to get a 2nd dose until the pharmacy called her and told her that she was due for a 2nd dose. The patient states that she went in to get the dose, however, the pharmacy had given the vaccine dose to someone else. On 9th or 10th November 2018, after receiving SHINGRIX and Flu vaccine, the patient developed pain in both arms and hands and states that the pain felt like her hands and arms were on fire. On 14th November 2018, 216 days after receiving SHINGRIX and Flu vaccine, the patient developed a little rash and then by 16th November 2018, the rash had exploded all over her arms and there were hundreds of red dots on both arms. The patient stated that the rash was very painful and itchy. The patient stated that the rash lasted for a few weeks and then turned into sores. Less than a year after receiving SHINGRIX and Flu vaccine, the patient stated that she also experienced bleeding on her arms and stated that the bleeding would occur when her arms were touched. The patient stated that the rash was going away and at the time of reporting it has came back. The patient stated that she tried using BENADRYL and cortisone and nothing has worked for the rash. The patient has not seen her physician yet for these symptoms. The patient thought that the rash was either shingles or allergic eczema that was caused by the SHINGRIX vaccine. The reporter did not consent to follow-up.