Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site urticaria, Injection site warmth, Malaise, Pain, Rotator cuff repair
Clinical narrative: rotator cuff surgery; Puffiness / Swelling at the injection site; Hot to touch and swelling at the injection site; Bright redness, hot to touch and swelling at the injection site; Reaction at injection site as a large welp; Strong desire to eat dinner; Strong desire to eat dinner and sleep; Feeling achy, pain; Feeling achy, pain and over bad (malasie); She could remember her own name; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (as a child).   On 5th August 2020 17:00, the patient received the 1st dose of Shingrix (intramuscular). On 6th August 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, injection site erythema, injection site wheal, increased appetite, sleepiness, pain, malaise and memory loss. On an unknown date, the patient experienced rotator cuff repair. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema, injection site wheal, increased appetite, sleepiness, pain, malaise, memory loss and rotator cuff repair were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema, injection site wheal, increased appetite, sleepiness, pain, malaise, memory loss and rotator cuff repair to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix in left arm. The next day patient noticed puffiness, bright redness, hot to touch and swelling at the injection site.  The patient described reaction at injection site as a large welp. The patient reported that her husband touched the affected area for examination. While at work the next day, the patient reported leaving midway through shift with a strong desire to eat dinner and sleep due to feeling achy, pain and over bad malasie. On the same night, the patient's sister called her and she could remember her own name. The patient had a surgery (rotator cuff) and at the time of reporting was on a leave of absence. The did not believe that the surgery contributed to side effects or her husband contracting shingles. The patient complained and was persistent that her husband contracted shingles from her between 15th to 17th August 2020 after she received Shingrix vaccine. The patient stated her husband had chickenpox as a child too, and that he did touch the welp on her injection site; her husband did not receive Shingrix. Initially the patient's husband suspected he had contracted poison ivy due to working outside, but was later diagnosed as shingles and prescribed an unspecified antiviral. The reporter was persistent her husband contracted shingles due to her receiving Shingrix vaccine and was hesitant to receive second dose due to risk of her husband contracted shingles again and similar or worse side effects for her. The reporter consented to follow up.