Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Lacrimation increased, Mobility decreased
Clinical narrative: Symptoms of the bell's palsey / Diagnosed with bell's palsey / mouth drooped a bit; Eye was tearing; She drooled; Headache; Was in bed / Could not get out of bed; Flu-like symptoms; Sluggish; chills; Low grade fever/fever of 101; fatigue/ tired; Pain at the injection site; Muscle aches; joint pain; nausea; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix. On 21st June 2019, less than a day after receiving Shingrix, the patient experienced fever, injection site pain and headache. On 22nd June 2019, the patient experienced chills, fatigue, muscle pain, joint pain, nausea, mobility decreased, influenza-like symptoms and sluggishness. On 1st October 2019, the patient experienced bell's palsy (serious criteria GSK medically significant), eyes tearing and drooling. The patient was treated with acyclovir and prednisone. On an unknown date, the outcome of the bell's palsy was recovering/resolving and the outcome of the chills, fever, fatigue, injection site pain, muscle pain, joint pain and nausea were resolved with sequelae and the outcome of the headache was not recovered/not resolved and the outcome of the mobility decreased, influenza-like symptoms and sluggishness were recovered/resolved and the outcome of the eyes tearing and drooling were unknown.   It was unknown if the reporter considered the bell's palsy, chills, fever, fatigue, injection site pain, muscle pain, joint pain, nausea, headache, mobility decreased, eyes tearing, drooling, influenza-like symptoms and sluggishness to be related to Shingrix.  Additional details were provided as follows: The reporter stated that vaccine was administered 2 months ago. The patient experienced pain at the injection site that lasted a day or two. The patient had headache and low grade fever of 101 presented the evening of the day if was administered. The next day the remaining symptoms presented and lasted 3 days. On 22 June 2019, 1 day after receving Shingrix the patient experienced chills, fatigue, muscle pain, joint pain, nausea, mobility decreased, influeza-like symptoms and sluggishness, lasted about 3 days. She was in bed for 3 days. The reporter stated that by the fourth day she was much better but still not 100 percent. The night before last she started to experience symptoms of the bell's palsey. The pharmacist reports the patient experienced a side effect and was diagnosed with Bells Palsy following dose one of Shingrix. The healthcare professional (HCP) notes side effect was described as tired. The patient was diagnosed with Bells Palsy. The reporter stated that patient eye was tearing and her mouth drooped a bit and she drooled. The reporter stated that by yesterday morning the symptoms were worst and she was diagnosed with the bell's palsey. The patient was being treated with prednisone and acyclovir. The reporter was consented to follow up. The patient provided permission to contact her pharmacist for follow up.