Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 51-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included shingles (several times) and systemic lupus erythematosus. Concomitant products included SHINGRIX. On 6th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th July 2018, 1 days after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site warmth, blotchy, pain in arm, erythema of extremities and injection site muscle pain. The patient was treated with (NOS) Steroids and Antibiotics (Brand Names Not Known). On 11th July 2018, the outcome of the extensive swelling of vaccinated limb was recovered/resolved. In July 2018, the outcome of the injection site warmth was recovered/resolved. On an unknown date, the outcome of the cellulitis, blotchy, pain in arm, erythema of extremities and injection site muscle pain were unknown. It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, injection site warmth, blotchy, pain in arm, erythema of extremities and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 7th May 2018 and did not have any adverse reactions with the 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX vaccine in right arm.  She reported that she told the pharmacist administering the vaccine that she had a massage prior to arriving at the pharmacy so her arm was oily. The pharmacist told her that was not a problem and applied hand sanitizer to the injection site prior to administering the vaccine. She did not wipe off the hand sanitizer prior to injecting the SHINGRIX. She reported that her arm was a little sore and red Saturday morning. However, by late Saturday, her arm was swollen from her right shoulder down to her elbow. She described an intense red area at the injection site and it was very hot. The injection site was not painful but the arm hurt due to the swelling. By Monday, 9th July 2018, her entire right arm was swollen, the red circle had moved down her arm, and her right hand was red and blotchy. She went to see her physician and was given a steroid injection, oral steroids, and an antibiotic because she was diagnosed as probably having cellulitis. By Wednesday, 11th July 2018, her arm was back to its normal size. She said the muscle where the injection was administered had deep pain but it did not hurt when you roll over on it or touch it. She could still see the red area but it was very light and the injection site was not as hot. The patient was concerned that this reaction was due to the pharmacist using the hand sanitizer on her arm and not wiping it off. The pharmacy manager told her that she had never seen a reaction to the vaccine like this before. The patient did not know the name of the pharmacist that administered the vaccine but reported she was new to the pharmacy.