Age: 70.0
Sex: F
Vaccine: UNK, UNK, UNK, VARZOS, VARZOS
Symptoms: Facial paralysis, Herpes zoster oticus, Neuralgia, Sensitive skin, Vaccination failure
Clinical narrative: suspected vaccination failure; diagnosed her with Ramsay Hunt Syndrome; she developed Face drooping / was diagnosed with bells palsy; She had nerve pain; had a little bit of sensitivity in her cheek; This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number B7973 ?, expiry date unknown, GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number J4D5J, expiry date 28th February 2021) for prophylaxis, valaciclovir hydrochloride (Valtrex) unknown for product used for unknown indication, prednisone for product used for unknown indication and gabapentin for product used for unknown indication.   The patient's past medical history included chickenpox. Previously administered products included zostavax (received in 2015, over 5 years ago from the date of reporting).   On 25th July 2018, the patient received the 1st dose of Shingrix. On 22nd October 2018, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started Valtrex at an unknown dose and frequency, prednisone at an unknown dose and frequency and gabapentin at an unknown dose and frequency. In April 2020, between 1 and 2 years after receiving Shingrix, Shingrix and Valtrex, the patient experienced sensitive skin. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), ramsay-hunt syndrome (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and nerve pain. The patient was treated with antibiotics nos. The dose of Valtrex was decreased. The dose of prednisone was decreased. The dose of gabapentin was decreased. On 20th April 2020, the outcome of the sensitive skin was recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ramsay-hunt syndrome, bell's palsy and nerve pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome, bell's palsy, nerve pain and sensitive skin to be related to Shingrix and Shingrix. It was unknown if the reporter considered the sensitive skin to be related to Valtrex.  Additional case details were reported as follows: This case was reported by patient herself. The retired nurse reported that Shingrix seemed to have reactivated the chicken pox virus in her.  The patient developed face drooping, was diagnosed with Bell's palsy and was put on antibiotics by a physician assistant.  The patient then went to an ENT (ear nose throat) physician, who diagnosed her with Ramsay Hunt Syndrome.  She had nerve pain and did not have any rashes.   The patient was given a tapering dose of Prednisone, Gabapentin and Valtrex.  Over the weekend before date of reporting, the patient had a little bit of sensitivity in her cheek, which precipitated her call to GSK.  It was unknown if the reporter considered sensitive skin to be related to Prednisone and Gabapentin. This case was considered as suspected vaccination failure as details regarding time to onset was unknown the time of reporting. The reporter consented to follow up.