Sex: F
Vaccine: VARZOS
Symptoms: Chills, Deafness, Ear discomfort, Ear pain, Erythema
Clinical narrative: Shingles; she started having pain on the left side of her head, behind her left ear and she feels pressure behind her left eye; Postherpetic Neuropathy; she started having sudden headaches that were diagnosed as migraine headaches; Headache; Pain behind left ear; Hearing Loss; she started having pain on the left side of her head, behind her left ear and she feels pressure behind her left eye/her ear feels clogged today; she was achy; Had a fever; Felt awful; Chills during that night; Heat in arm; Red Arm; Sore Arm; This serious case was reported by a consumer via call center representative and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she had shingles behind her left ear, on the left side of her head, and the back of her eye about 20 years ago).   On 17-MAR-2023, the patient received the 1st dose of Shingrix (right arm). In MAR-2023, less than a day after receiving Shingrix, the patient experienced extremities hot feeling of (Verbatim: Heat in arm), erythema of extremities (Verbatim: Red Arm) and pain in arm (Verbatim: Sore Arm). On 17-MAR-2023, the patient experienced pain (Verbatim: she was achy), fever (Verbatim: Had a fever), feels awful (Verbatim: Felt awful) and chills (Verbatim: Chills during that night). On 24-AUG-2023, the patient experienced hearing loss (Verbatim: Hearing Loss) (serious criteria GSK medically significant) and ear feels clogged (Verbatim: she started having pain on the left side of her head, behind her left ear and she feels pressure behind her left eye/her ear feels clogged today). On an unknown date, the patient experienced shingles (Verbatim: Shingles), pain behind eyes (Verbatim: she started having pain on the left side of her head, behind her left ear and she feels pressure behind her left eye), post herpetic neuralgia (Verbatim: Postherpetic Neuropathy), migraine headache (Verbatim: she started having sudden headaches that were diagnosed as migraine headaches), headache (Verbatim: Headache) and ear pain (Verbatim: Pain behind left ear).  The patient was treated with meloxicam and gabapentin. On 19-MAR-2023, the outcome of the chills was resolved (duration 2 days). The outcome of the hearing loss, pain behind eyes, ear feels clogged, pain, post herpetic neuralgia, migraine headache and headache were not resolved and the outcome of the shingles was not reported and the outcome of the fever, feels awful, extremities hot feeling of, erythema of extremities and pain in arm were resolved and the outcome of the ear pain was unknown.   It was unknown if the reporter considered the hearing loss, shingles, pain behind eyes, ear feels clogged, pain, fever, feels awful, extremities hot feeling of, erythema of extremities, pain in arm, chills, post herpetic neuralgia, migraine headache, headache and ear pain to be related to Shingrix.     It was unknown if the company considered the hearing loss, shingles, pain behind eyes, ear feels clogged, pain, fever, feels awful, extremities hot feeling of, erythema of extremities, pain in arm, chills, post herpetic neuralgia, migraine headache, headache and ear pain to be related to Shingrix.   Additional Information: Receipt Date: 24-AUG-2023 The reporter reported that the patient received Shingrix vaccine from her pharmacist and around the same time around that same time as no specific date, she started experiencing sudden headaches that were diagnosed as migraine headaches by her physician. Patient reported that on the evening after the 1st Shingrix vaccine she was achy and felt awful and had a little fever.  Patient reported that during the night of 17th March 2023 and 18th March 2023 her arm was sore, a little red, and had heat in it. Patient also reported that she had a fever and chills during that night of 17th March 2023, the next day 18th March 2023 and into the next day, 19th March 2023, that lasted about 48 hours.  Patient reported that her current migraine headaches follow the same nerve bundle as the past episode of Shingles.  Patient reported that if she sits down then after 10 minutes the headaches will go away.  Patient reported that around the same time with no specific date provided that she got the 1st dose of Shingrix, she started having pain on the  left side of her head, behind her left ear and she feels pressure behind her left eye just like when she had shingles in the past.  Patient reported that her ear feels clogged and she had lost some hearing, which was diagnosed by her physician and told her it sounded like she was having a migraine headaches and shingles.  Physician prescribed Meloxicam 7.5 mg daily and Gabapentin 300 gram three times a day and diagnosed her with Post herpetic neuropathy, which was in the same place where she had Shingles years ago, and was worse when she did activities.  Patient was had a headache today, 24th August 2023 on the left side of her head. The reporter did not consent to follow up.