Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Ocular hyperaemia, Oral pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: right sided mouth pain; bloodshot eyes; she is IGM positive; her right temple is sensitive to touch/left temple; pain behind right eye; pain on the right side of her face; right side head pain/temporal headache; shingles outbreak; high fever; tachycardia; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of fever in a 46-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had history of shingles affecting right trigeminal nerve without blisters) and post herpetic neuralgia. Concomitant products included carbamazepine (Tegretol).   On 12-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 12-SEP-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 15-SEP-2023, the patient experienced fever (Verbatim: high fever) and tachycardia (Verbatim: tachycardia). On 10-OCT-2023, the patient experienced headache (Verbatim: right side head pain/temporal headache). On 11-OCT-2023, the patient experienced pain behind eyes (Verbatim: pain behind right eye), facial pain (Verbatim: pain on the right side of her face) and touch sensitivity increased (Verbatim: her right temple is sensitive to touch/left temple). In OCT-2023, the patient experienced shingles (Verbatim: shingles outbreak). On 18-OCT-2023, the patient experienced igm (Verbatim: she is IGM positive). On an unknown date, the patient experienced oral pain (Verbatim: right sided mouth pain) and bloodshot eye (Verbatim: bloodshot eyes). the patient experienced . The patient was treated with paracetamol (Acetaminophen), ibuprofen, naproxen (Aleve) and steroids nos (Steroid Injection). The outcome of the fever, tachycardia, shingles, pain behind eyes, headache, igm, touch sensitivity increased, oral pain and bloodshot eye were not resolved and the outcome of the facial pain and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the fever, tachycardia, pain behind eyes, facial pain, headache, igm, touch sensitivity increased, oral pain and bloodshot eye to be related to Shingrix. The reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the fever, tachycardia, pain behind eyes, facial pain, headache, igm, touch sensitivity increased, oral pain and bloodshot eye to be related to Shingrix. The company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 20-Oct-2023 and 23-Oct-2023 The patient took tegratol for a couple of years because of this, and just weaned off of it about a month and a half ago. The patient received a dose of Shingrix because of her shingles history and for three days injection she experienced high fever and tachycardia, for which she took acetaminophen and ibuprofen. On 10th October 2023, she began having right side head pain in the same location of her original shingles.  She also had bloodshot eyes, right sided mouth pain, and temporal headache. On 11th October 2023, she experienced pain on the right side of her face, and behind her right eye, her right temple was sensitive to touch.    In October 2023, less than 2 months after the injection, last week she began having symptoms mirroring the symptoms she gets with a shingles outbreak, but again with no blisters.  She asked if Shingrix would cause that lab outcome. She sought care at an urgent care facility and received a steroid injection, which improved symptoms and also saw her physician checked IgM, which came back positive, and physician believes she has had a reactivation of shingles, so tegretol was restarted.  She was still also taking acetaminophen and Aleve.  She did not had the lot number/expiration date. Reporter gave permission to follow-up with her or her physician's office. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.