Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Post inflammatory pigmentation change
Clinical narrative: Post inflammatory hyperpigmentation of the skin; Post inflammatory hyperpigmentation of the skin; bruises in my skin; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin hyperpigmentation in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 259G2, expiry date 15-MAY-2025) for prophylaxis.   On 14-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In AUG-2023, 10 days after receiving Shingrix, the patient experienced skin hyperpigmentation (Verbatim: Post inflammatory hyperpigmentation of the skin), inflammation (Verbatim: Post inflammatory hyperpigmentation of the skin) and contusion (Verbatim: bruises in my skin). Shingrix was discontinued. The outcome of the skin hyperpigmentation and contusion were not resolved and the outcome of the inflammation was not reported.   The reporter considered the skin hyperpigmentation, inflammation and contusion to be related to Shingrix.     The company considered the skin hyperpigmentation, inflammation and contusion to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUN-2024 The patient got the shingles vaccine, and the pharmacy just called her last Friday to arrange to put the second dose. The patient informed them that she decided not to get the second dose of this vaccine since she got a bad reaction in her skin from the first dose. The pharmacy suggested her to contact them to report it. The patient on the day of reporting went to the pharmacy to pick up the details of the vaccine. Like ten days after the first shingles vaccine, she started to show bruises in her skin (abdomen, back, armpits, neck). The patient immediately thought it as a reaction of the vaccine and her primary doctor said to wait because it would go probably away. Then since the bruises did not go away and instead got darker, her doctor started ordering blood tests to be sure the bruises were not related to her blood, but everything was ok with her blood, back then they only found low iron. So, it was not too long ago when she finally was seen by a dermatologist that told her that she gave a post inflammatory hyperpigmentation of the skin due to a medicine. Because of this adverse reaction she had decided not to take the second dose of Shingles vaccine. The bruises were still all over her body (abdomen, back, armpits, neck) and they had not gone away. The marks started to get darker, and they did not seem to disappear with time. The patient was open to further investigation on her end in order to had these bruises disappear from her skin. The lot number provided for this case did not come up in the system; The NDC (national drug code) provided corresponds to the outer carton for a 10 dose pack of Shingrix. The patient reported that both she and her doctor found this adverse reaction of bruises/spots all over her to be scary. The patient reported that she made no other changes other than having received the first dose of Shingrix. The patient reported no adverse reaction at the injection site. She reported all that was provided about this adverse event. The reporter consented to follow up.