Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: not sleeping well last night; Redness at the injection site, large as whole hand; Pain at the injection site; Swelling at the injection site, large as whole hand/ swelling area becoming as large as her whole hand; Felt freezing; Fever as high as 101F; Headache / headache is very unusual for her/ she no longer has headache; Tiredness/she is less tired; Myalgia; Upset stomach; Stomach pain; Skin hurt; Muscle pain in the back; Muscle pain in sides and legs; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th November 2022, 8 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site pain, extensive swelling of vaccinated limb, feeling cold, fever, headache, tiredness, myalgia, upset stomach, stomach pain and skin pain. On 13th November 2022, the patient experienced insomnia. In November 2022, the patient experienced muscular back pain and pain in extremity. On 12th November 2022, the outcome of the feeling cold and fever were recovered/resolved. On an unknown date, the outcome of the injection site erythema and extensive swelling of vaccinated limb were not recovered/not resolved and the outcome of the injection site pain was unknown and the outcome of the muscular back pain, pain in extremity, tiredness, myalgia, upset stomach, stomach pain, skin pain and insomnia were recovering/resolving and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, extensive swelling of vaccinated limb, feeling cold, fever, muscular back pain, pain in extremity, headache, tiredness, myalgia, upset stomach, stomach pain, skin pain and insomnia to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comment: The reporter was the patient who had received her first Shingrix dose. The patient had reported that, 8 hours after receiving her first Shingrix dose, she had experienced redness, pain and swelling at the injection site, which was increased over the next 2 days with redness, and swelling area becoming as large as her whole hand. The patient stated that she had felt freezing at 2am and had fever as high as 101 F that night which both had resolved the next day. The patient also stated that, she had experienced muscle pain in the back, sides and legs, headache (headache, which was very unusual for her), tiredness, upset stomach, stomach pain and her skin hurt. The patient also reported of not sleeping well last night. As per the patient, she no longer had headache, she was less tired, her skin was only slightly hurting, and all the other symptoms were resolving at this time. The reporter had consented to follow-up. Less than a week, after receiving Shingrix, the patient experienced muscular back pain and pain in extremity and Less than a day after receiving Shingrix, the patient experienced Feeling cold, Fever. 2 days after receiving Shingrix, the patient experienced insomnia.