Sex: F
Vaccine: VARZOS
Symptoms: Drooling, Ear discomfort, Ear pain, Facial paralysis, Facial paresis
Clinical narrative: felt like her lips were numb; left ear pressure; left jaw numbness; drooling; Mld left sided headache; left sided lower facial muscle weakness; left sided lower facial muscle weakness / diagnosed / left sided bell's palsy / facial drooping; had left ear pain; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number J2N44, expiry date 17th May 2022) and (batch number 7TB74, expiry date 17th May 2022) for prophylaxis.   The patient's past medical history included cervical cancer, thyroid papillary carcinoma, chronic back pain, thyroid gland cancer and hysterectomy. Concurrent medical conditions included hypertension. Concomitant products included thyroxine sodium (Levothyroxine), amitriptyline and amlodipine.   On 18th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. In November 2020, less than a day after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and ear pain. On 18th November 2020, the patient experienced numb lips, sensation of pressure in ear, numbness facial, drooling, headache and facial muscle weakness. The patient was treated with prednisone and valaciclovir (Valacyclovir). On an unknown date, the outcome of the bell's palsy, numb lips, sensation of pressure in ear, numbness facial, drooling, headache and facial muscle weakness were not recovered/not resolved and the outcome of the ear pain was recovered/resolved.   It was unknown if the reporter considered the bell's palsy, ear pain, numb lips, sensation of pressure in ear, numbness facial, drooling, headache and facial muscle weakness to be related to Shingrix.  Additional information received as follows: The age at vaccination was not reported. The patient received Shingrix in left deltoid and had left ear pain for less than 3 days. She stated that, on the day of vaccination for the past hour she felt like her lips were numb and she went to an urgent care that day within an hour or so of reporting her concerns and reported that she had left ear pressure and left jaw numbness and a little bit of drooling.  She had a mild left sided headache.  Her diagnosis was left sided lower facial muscle weakness including the left side of her mouth and lower left side of her face without anything on the right side.  She was diagnosed with left sided bell's palsy on 24th November 2020.  She was prescribed prednisone 60 mg. daily for 7 days and 1 gram of valacyclovir three times per day for 7 days.  On27th November 2020, she was taking the prescribed medication and she felt that her symptoms were the same but no new symptoms.  On 30th November 20, she reported feeling that there was slight improvement in her facial drooping.  She had a recent primary care visit on 21st Octo 20 with no mention of any concern.   The reporter consented to follow up. Lot number provided was listed in the patient's medical chart with two separate vials for the vaccine.