Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pyrexia
Clinical narrative: she noticed a big, red, inflamed local reaction at the injection site; she noticed a big, red, inflamed local reaction at the injection site; a low grade fever the past 2 days; having pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 31-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's disease.   On 09-JAN-2024 16:00, the patient received the 1st dose of Shingrix (intramuscular, left arm) 50 ug. On 09-JAN-2024 21:00, 5 hrs after receiving Shingrix, the patient experienced injection site pain (Verbatim: having pain at the injection site). On 10-JAN-2024, the patient experienced low grade fever (Verbatim: a low grade fever the past 2 days). On 10-JAN-2024 16:00, the patient experienced injection site inflammation (Verbatim: she noticed a big, red, inflamed local reaction at the injection site) and injection site redness (Verbatim: she noticed a big, red, inflamed local reaction at the injection site). The patient was treated with paracetamol (Tylenol) and diphenhydramine hydrochloride (Benadryl). On 11-JAN-2024, the outcome of the low grade fever was resolved (duration 1 day). The outcome of the injection site inflammation, injection site redness and injection site pain were not resolved.   It was unknown if the reporter considered the injection site inflammation, injection site redness, injection site pain and low grade fever to be related to Shingrix.  It was unknown if the company considered the injection site inflammation, injection site redness, injection site pain and low grade fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JAN-2024 The patient with Crohn's disease reported, that she received her 1st dose of Shingrix and had pain at the injection site about 5 hours after receiving the injection. The patient still had injection site pain on the day of reporting. The patient also reported starting about 24 hours after receiving the Shingrix injection, 10-JAN-2024 around 4 to 5 PM, she noticed a big, red, inflamed local reaction at the injection site. The patient reported that red area at the injection site started about the size of a half dollar; and, on the day of reporting, she still had that red, inflamed area at the injection site that kept getting bigger and was now the size of a soft ball. The patient also reported a low-grade fever the past 2 days. The patient did have photos if safety requested them. The patient reported taking 2 extra strength Tylenol twice a day, every day, starting the evening of the injection 9-JAN-2024 at 8 PM. The patient also reported taking Benadryl on 11-JAN-2024, 1 tablet at 1 PM and 1 tablet at 6PM. The patient did not have the lot/expiry information. The patient was immunocompromised with Crohn's Disease, therefore her physician wanted her to get the Shingrix vaccine before changing her medication regimen. The reporter consented to follow-up.