Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Blood glucose increased, Cellulitis, Extra dose administered, Glycosylated haemoglobin normal, Wrong product administered
Clinical narrative: injections were given in the right arm. The patient developed cellulitis in that arm; normally has blood sugars in the 100 range, 190 maximum / blood sugars have been in the 200-300 range; asked for a Shingrix shot / accidentally gave her another high potency flu shot; mid-August 2020 she received the high potency flu shot for seniors over age 65 / Two weeks later (approximately) / accidentally gave her another high potency flu shot; This case was reported by a consumer via call center representative and described the occurrence of cellulitis of arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included diabetes.   In September 2020, the patient received the 1st dose of Shingrix and the 2nd dose of Influenza vaccine Quadrivalent 2020-2021 season. In August 2020, the patient received the 1st dose of Influenza vaccine Quadrivalent 2020-2021 season. In September 2020, not applicable after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season and unknown after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the patient experienced cellulitis of arm (serious criteria GSK medically significant) and blood sugar increased. The patient was treated with cefalexin (Keflex). On an unknown date, the outcome of the cellulitis of arm was recovered/resolved and the outcome of the blood sugar increased was not recovered/not resolved and the outcome of the wrong vaccine administered and extra dose administered were unknown.   The reporter considered the cellulitis of arm to be related to Shingrix, Influenza vaccine Quadrivalent 2020-2021 season and Influenza vaccine Quadrivalent 2020-2021 season. The reporter considered the blood sugar increased to be possibly related to Shingrix. It was unknown if the reporter considered the blood sugar increased to be related to Influenza vaccine Quadrivalent 2020-2021 season and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at the vaccination was not reported. In mid of August 2020 the patient received the high potency flu shot for seniors over age 65. Two weeks later (approximately) the patient came back and asked for a Shingrix shot (dose 1) but the pharmacist accidentally gave her another high potency flu shot, which led to wrong vaccine administered. The pharmacist filed an incident report and notified the patient's doctor.   The following day (around the 6th or 7th of September 2020) the patient received Shingrix dose one (at the request of her doctor).  All three of the injections were given in the right arm. The patient developed cellulitis in that arm. The cellulitis resolved. The cellulitis was treated with 5 days of generic Keflex (cephalexin). The patient believed the cellulitis was due to the fact that all 3 injections were given in the same arm within a 2 (to 3) week period.   She stated that the pharmacy offered to pay for her cellulitis doctor visit.  The reporter did provide her pharmacy's name and phone number so that GlaxoSmithKline could contact the pharmacy to confirm the names of the vaccines, the lot number(s), and whether or not they were given intramuscularly.  The patient mentioned that she is diabetic and that she normally had blood sugars in the 100 range, 190 maximum and she worked hard to get her a1c (Hemoglobin A1c) down to 6.3 but lately her blood sugars had been in the 200-300 range.  She was concerned that Shingrix may have something to do with this. She was due for shot dose 2 of the Shingrix series but her doctor had recommended that she post-pone the Shingrix dose.