Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: very sore around eye; pain in head prevents from sleeping at night; touching the head causes pain; sore neck; pain in the head, headache, entire left side; requesting a MRI at the time of the visit, as the pain in their head was so bad they believed they had a tumor; soreness; diagnosed with shingles; rash above left eye, eyelid, eyebrow and ear; red rash; painful blisters, started to harden; severe pain in left ear; This non-serious case was reported by a consumer via call center representative and described the occurrence of ear pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles prior to vaccination).   On 28-JAN-2023, the patient received the 1st dose of Shingrix (right arm). On 10-MAR-2023, 41 days after receiving Shingrix, the patient experienced ear pain (Verbatim: severe pain in left ear). On 15-MAR-2023, the patient experienced shingles (Verbatim: diagnosed with shingles), rash (Verbatim: rash above left eye, eyelid, eyebrow and ear), red rash (Verbatim: red rash) and blister (Verbatim: painful blisters, started to harden). On an unknown date, the patient experienced sore eye (Verbatim: very sore around eye), insomnia (Verbatim: pain in head prevents from sleeping at night), tenderness (Verbatim: touching the head causes pain), neck pain (Verbatim: sore neck), headache (Verbatim: pain in the head, headache, entire left side), tumor (Verbatim: requesting a MRI at the time of the visit, as the pain in their head was so bad they believed they had a tumor) and pain (Verbatim: soreness). The patient was treated with paracetamol (Acetaminophen), prednisone, hydrocodone, gabapentin and valaciclovir hydrochloride (Valtrex). The outcome of the ear pain, shingles, rash, red rash, blister, sore eye, headache and pain were not resolved and the outcome of the insomnia, tenderness, neck pain and tumor were not reported.   It was unknown if the reporter considered the ear pain, shingles, rash, red rash, blister, sore eye, insomnia, tenderness, neck pain, headache and pain to be related to Shingrix. The reporter considered the tumor to be possibly related to Shingrix.     It was unknown if the company considered the ear pain, shingles, rash, red rash, blister, sore eye, insomnia, tenderness, neck pain, headache and pain to be related to Shingrix. The company considered the tumor to be possibly related to Shingrix.   Additional Information: GSK receipt date: 23-Mar-2023 The caller was the patient. The caller reported experiencing shingles prior to being vaccinated, but stated this was worst occurrence. The caller reported that she received a dose of Shingrix and experiencing severe pain in the left ear. On 13th March 2023, the called saw the physician and being advised that did not had an ear infection and likely had shingles. The caller reported requesting magnetic resonance imaging at the time of visit, as the pain in the head was so bad that they believed had a tumor. The caller reported taking Acetaminophen 650 mg for pain, to no available.  On 15th March 2023, the caller having another appointment, but broke out in a rash on that day prior to the appointment and she was being advised to keep that appointment and was diagnosed with shingles during that appointment.  The caller reported rash was above left eye, in left eyelid and eyebrow, and all around their left ear, and just beyond their hairline and the rash contains painful blisters and was red.  The caller reported being prescribed Prednisone, Valtrex, and Hydrocodone for pain and hydrocodone did nothing for the pain in their head, which encompassed the entire left side of their head, including behind their left eye.  On 17th March 2023, the caller was being prescribed Gabapentin, after the Hydrocodone did not relieve the pain and was being up to 3 pills per day for pain, after starting at 1 per day.  The caller reported seeing optometrist and being advised ocular pressure was good, the area around the eye was very sore, rash was still visible.  The caller reported pain in the head often prevents them from sleeping at night.  The caller reported touching the head causes pain caller likened to broken glass in the head, the neck was sore, but there was no rash.  The caller reported rash was contained to the left face and head and pain had gotten more tolerable, but was still severe at times.  The caller reported blisters had started to harden.  On 23rd March 2023, in this morning, the caller had a throbbing headache.  The reporter consented to follow-up. Tumor event was coded conservatively based upon the narrative verbatim.