Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Insomnia, Irritability, Pain
Clinical narrative: around the injection site, she had a rash that was really swelling, red, and the redness was spreading; around the injection site, she had a rash that was really swelling, red, and the redness was spreading; around the injection site, she had a rash that was really swelling, red, and the redness was spreading; Irritation; Pain; redness was spreading; tenderness at the injection site; Cannot sleep; Tiredness; hardly keep her eyes open; feels like little bugs or electrodes going all through her arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 27-SEP-2024, the patient received the 2nd dose of Shingrix (left arm). In SEP-2024, an unknown time after receiving Shingrix, the patient experienced sleeplessness (Verbatim: Cannot sleep), tiredness (Verbatim: Tiredness), tired eyes (Verbatim: hardly keep her eyes open) and formication (Verbatim: feels like little bugs or electrodes going all through her arm). On 27-SEP-2024, the patient experienced injection site tenderness (Verbatim: tenderness at the injection site). On 28-SEP-2024, the patient experienced injection site erythema (Verbatim: around the injection site, she had a rash that was really swelling, red, and the redness was spreading), injection site swelling (Verbatim: around the injection site, she had a rash that was really swelling, red, and the redness was spreading), injection site rash (Verbatim: around the injection site, she had a rash that was really swelling, red, and the redness was spreading), irritability (Verbatim: Irritation), pain (Verbatim: Pain) and erythema (Verbatim: redness was spreading). The outcome of the injection site tenderness, injection site erythema, injection site swelling, injection site rash, irritability, pain, sleeplessness, tiredness, tired eyes, formication and erythema were not resolved.   It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site swelling, injection site rash, irritability, pain, sleeplessness, tiredness, tired eyes, formication and erythema to be related to Shingrix.     It was unknown if the company considered the injection site tenderness, injection site erythema, injection site swelling, injection site rash, irritability, pain, sleeplessness, tiredness, tired eyes, formication and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-SEP-2024 and 01-OCT-2024 The patient was the reporter. The reporter reported that she received Shingrix in her left arm and she had developed tenderness at the injection site that same day of the vaccination. The patient reported that starting the next day of vaccination, Saturday, 28th September 2024, on her left arm around the injection site, she had a rash that was really swelling, red, and the redness was spreading. The patient reported that the rash was not bumpy.  The patient reported that the pain and irritation that started on Saturday, 28th September 2024 and she was still experiencing at the time of reporting and it felt like little bugs or electrodes going all through her arm.  The patient also reported that she could not sleep due to the pain and irritation. The patient reported that she was experiencing tiredness and could hardly keep her eyes open.  The reporter reported that she was using ice packs (no further information provided).  The reporter consented to follow up.