Age: 71.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Pleural effusion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. Concomitant products included FLUZONE. On 24th October 2018, the patient received the 1st dose of SHINGRIX 50 µg and PNEUMOVAX 23. On 24th October 2018, less than a day after receiving SHINGRIX, the patient experienced feeling bad and fever. On 25th October 2018, the patient experienced chills, headache and feeling unwell. On 27th October 2018, the patient experienced chest pain, increased blood pressure, pleural effusion, difficulty breathing and exertional dyspnea. On 30th October 2018, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), antinuclear antibody increased and elevated sedimentation rate. On an unknown date, the patient experienced weakness. The patient was treated with Nitroglycerin, Aspirin, PLAQUENIL and Steroids. On an unknown date, the outcome of the systemic lupus erythematosus, feeling bad, fever, chills, headache, chest pain, increased blood pressure, pleural effusion, difficulty breathing, antinuclear antibody increased, elevated sedimentation rate, weakness, exertional dyspnea and feeling unwell were unknown. It was unknown if the reporter considered the systemic lupus erythematosus, feeling bad, fever, chills, headache, chest pain, increased blood pressure, pleural effusion, difficulty breathing, antinuclear antibody increased, elevated sedimentation rate, weakness, exertional dyspnea and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she had PNEUMOVAX 23 along with SHINGRIX. The patient received those in opposite arms but not sure which arm was which. She did not had lot information. The patient also noted she had FLUZONE the week before without reaction in her left arm. On 24th October 2018, at 9 pm she noted she felt bad and probably had a fever. On 24th October 2018, 1 day after receiving SHINGRIX, she had to stay in bed all day, had fever, chills, headache, and just did not feel well. On 26th October 2018, the patient traveled but still felt about the same. On 27th October 2018, 3 days after receiving SHINGRIX, Saturday she was traveling back home and was hurting so bad in her chest she went to a hospital Emergency room. Her blood pressure was 240/100. She was given nitroglycerin because it was thought she was having a heart attack. The patient stated she was also given Aspirin and an EKG was negative for MI. But a chest x-ray showed her chest was filled with fluid and she was diagnosed with CHF and sent home to follow up with a cardiologist. She noted she was still hurting when she left the hospital. She noted she was there from 7 pm to 10 pm. She saw a cardiologist on 10/29 and was told she did not have Congestive Heart Failure by Echocardiogram. Three days after receiving SHINGRIX, the patient noted she was having difficulty breathing, she had to sit up and could not lay down due to the breathing difficulty. On 30th October 2018, she underwent a same day Heart catherization and no blockages were identified. 6 days after receiving SHINGRIX, the patient noted that also ran a serious of blood tests and she had an elevated ANA and Sedimentation Rate. The patient stated she was informed of these results on 11/5 when she followed up with her primary care physician. 6 days after receiving SHINGRIX, it was then that she was diagnosed with Lupus, which she had never had the symptoms before. She believed the vaccinations triggered the events even if they were dormant. She was placed on PLAQUENIL and steroids 20mg bid x 2 weeks. The patient noted after a week of the medications she was feeling and breathing better. The patient was able to lie down and she was pleased her creatinin level was not high anytime during all the events. She also saw her Primary Care Physician, who was keeping her on the PLAQUENIL and plans to monitor the blood work again in 3 months. The patient stated no blood work was done. The patient stated she no longer has the chest pain but was still week and still has slight fluid around her lungs and does get breathless with exertion but doing much better. She has been told by her Primary physician and the Cardiologist not to get the second dose of SHINGRIX. The reporter gave consent to follow up.