Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of Bell's palsy in a 74-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. Concomitant products included Aspirin, Hydrochlorothiazide and JANUMET. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 11 days after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria hospitalization and GSK medically significant), numbness facial (serious criteria hospitalization), drooling (serious criteria hospitalization), fatigue (serious criteria hospitalization) and ptosis (serious criteria hospitalization). The patient was treated with Valtrex and prednisone. On an unknown date, the outcome of the Bell's palsy, numbness facial, drooling, fatigue and ptosis were unchanged. The reporter considered the Bell's palsy, numbness facial, drooling, fatigue and ptosis to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm at 14:30 hours and less than a month post vaccination felt some fatigue after getting the SHINGRIX. On Sunday 6th May 2018, 11 days, 18 hours after vaccination, around 8:30 to 9:30 AM in the morning the patient felt like her eyes were drooping, mouth was drooling, and felt facial numbness mainly on the right side of the face going to the left side of the face. Later on the day, the patient went to the emergency department at hospital. The hospital performed nuclear magnetic resonance imaging, angiogram, computerized tomogram scan and blood work and no remarkable findings were noted. On Monday, 7th May 2018, the patient had a definitive diagnosis with left side facial Bell's palsy and was hospitalized for total of 1 day. She was being treated with Prednisone and VALTREX, at the time of reporting. The patient had denied permission to contact their physician. Follow up information received from an other health professional on 14th May 2018: The reporter's details were updated. The reporting pharmacist was the patient. The patient contacted GSK previously and she called back GSK without any question to be researched. A Product Specialist transferred the patient because she requested to speak with a pharmacist. The patient called to report her concern as a health care provider who has previously taught ethics and jurisprudence that a person walking by inside a pharmacy or grocery should never be stopped and recommended to had the shingles shot and should really be referred by a doctor because so many people including herself had compromised medical histories. The patient was concerned that many of her friends described as lay people who were medically compromised were sort of being twisted a bit to went in and had the SHINGRIX without having their doctor evaluate first. The patient had limited time to further discuss stating she needed to end the call in order to go to a doctor's appointment. Before ending the call, the patient said her SHINGRIX vaccination was administered around 2:30 PM and that her neurologist in the hospital had said it was too coincidental for her to had been given the SHINGRIX vaccine and then to have been admitted with Bell's palsy. Less than a month post vaccination, it was very uncomfortable. Her vision and hearing had been affected. The whole left side of her face had been affected. The patient described that she was in a lot of physical, emotional, and mental distress. The patient said as a hygienist that she was having paralysis on the left side and was not being able to speak and was drooling along with her visions were being blurred was horrific. This was a serious situation which she would be pursing to the fullest and would be calling back GSK to further discuss. No information beyond what was documented above was provided or could be clarified due to time constraints. The outcome of the discomfort, blurred vision, and hearing impaired, dysarthia, physically unwell and emotional distress was unknown. It was unknown if the reporter considered the discomfort, blurred vision, hearing impaired, dysarthia, physically unwell and emotional distress to be related to SHINGRIX. This case was linked with US2018082823, reporter by the same reporter for the patient's husband. Upon internal clarification received on 23rd May 2018 from safety physician, following corrections were made in the case. The event speech loss was replaced with dysarthia. Follow up information received from a dental hygienist on 6th June 2018: The reporter's details were updated. The patient's details were updated. The VAERS details were updated. Sender's Comments: US2018082822: Previous VAERS submission in paper format.