Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: radiating pain has spread from side to side on upper arm; Small pink circular area on her upper arm / Bright red; Area on her upper arm that was warm to the touch / Arm described as very hot; Upset stomach; Difficulty sleeping; Difficulty moving arm; Uncertainty of cellulitis or allergic reaction; Uncertainty of cellulitis or allergic reaction; Injection as painful/Left arm became painful/Arm pain became worse; Felt the liquid suspension injecting into muscle; Swelling in upper arm; Tenderness; Pain in muscle of upper arm; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy (Allergic to several unspecified ingredients).   On 7th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th July 2020, less than a day after receiving Shingrix, the patient experienced injection site cellulitis, allergic reaction, injection site pain, injection site discomfort, injection site swelling, tenderness, myalgia, headache and injected limb mobility decreased. On 8th July 2020, the patient experienced injection site erythema, injection site warmth, upset stomach and difficulty sleeping. On 9th July 2020, the patient experienced radiating pain. The patient was treated with amoxicillin sodium, potassium clavulanate (Augmentin) and meloxicam. Shingrix was discontinued. On an unknown date, the outcome of the injection site cellulitis, allergic reaction, injection site discomfort, tenderness, myalgia, injection site warmth, difficulty sleeping and radiating pain were unknown and the outcome of the injection site pain, headache, injection site erythema, injected limb mobility decreased and upset stomach were recovering/resolving and the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site cellulitis, allergic reaction, injection site pain, injection site discomfort, injection site swelling, tenderness, myalgia, headache, injection site erythema, injection site warmth, injected limb mobility decreased, upset stomach, difficulty sleeping and radiating pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm in the afternoon. The patient described the injection as painful and reported both she and nurse felt the liquid suspension injecting into muscle.  The nurse commented to the patient that, she never felt that before. The patient reported that, afternoon into the evening, left arm became painful, pain in touching upper arm (tenderness), pain in muscle in upper arm when moved, swelling in upper arm, and headache.  The patient reported taking a picture of arm Wednesday morning on 8th July 2020, 1 day after receiving Shingrix and noticing a small pink circular area on her upper arm that was warm to the touch. Arm pain became worse and caused difficulty moving arm.  The patient described a jump when tender arm was touched. She was also reported having an upset stomach. That night the patient reported difficulty sleeping due to the pain spreading to the circumference of her upper arm. On 9th July 2020 morning, 2 days after receiving Shingrix, the patient took another picture of her arm and noticed the affected area spread.  The patient reported the area was no longer pink but now bright red, and the pain radiated throughout the surface of her upper arm.  Upper arm described as very hot and no longer a small circle.  The redness and radiating pain had spread from side to side on upper arm. Upset stomach currently described as mild. Swelling was still present at the time of reporting. The patient reported having an emergency visit with her physician on 9th July 2020 and being prescribed Augmentin due to uncertainty of cellulitis or allergic reaction due to history of allergies to many unspecified ingredients.  The patient reported icing and using cold compresses on the affected area.  The patient also reported taking meloxicam which was believed to help headache dissipate although headache was mildly present at the time of reporting. The reporter was consented to follow up.