Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: Needle was put it and burned l ke heck / could not bear the pain / burning and hurting; Her head kind of exploded and that was epic / head was just killing her; Felt really awkward; Arm was throbbing; Arm was throbbing and started screaming; Pain began in her lower back and her arm, head and right side of her hip and moved throughout her body; Area / injected was almost like a baseball sized circle and was read / injection site / turned red; Injection site / the band aid caused a bruise / Injection site is now black all around it; Injection site swelled / continued to swell; Ridiculous to have to use that arm and to lift it like a disabled arm / using that arm was insane; Chest pain; Back pain; Injection site black; This case was reported by a consumer via other manufacturer and described the occurrence of injection site burning in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9NH54, expiry date 14th October 2022) for prophylaxis.   Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE PFIZER) and TOZINAMERAN (COVID-19 MRNA VACCINE PFIZER).   On 1st May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st May 2021, less than a day after receiving Shingrix, the patient experienced injection site burning, headache, discomfort, pain in arm, screaming, pain, injection site erythema, injection site bruising, injection site swelling, injected limb mobility decreased, chest pain, back pain and injection site discoloration. On an unknown date, the outcome of the injection site burning, headache, discomfort, pain in arm, screaming, pain, injection site erythema, injection site bruising, injection site swelling, injected limb mobility decreased, chest pain, back pain and injection site discoloration were recovered/resolved.   It was unknown if the reporter considered the injection site burning, headache, discomfort, pain in arm, screaming, pain, injection site erythema, injection site bruising, injection site swelling, injected limb mobility decreased, chest pain, back pain and injection site discoloration to be related to Shingrix.  Additional details were provided as follow: The patient received Shingrix on 1st May 2021 The patient  stated that the needle was put in and burned like heck and her head was kind of exploded. The patient wanted to stay in store but felt awkward. The patient stated that her head settled down and her arm was throbbing and she started screaming. The patient stated the pain began in her lower back and her arm, head and right side of her hip and moved throughout her body. The pain rotated out everywhere after 30 minutes the pain settled down and she just had the pain in the arm. The patient stated that the area where vaccine was injected was almost like a baseball sized circle and was red, she removed band aid which caused a bruise and the injection site swelled up and she could not bear the pain. The patient stated that her head was killing her and it was ridiculous to use the arm and lift it like a disabled arm. All the reported events were now recovered/resolved but, the injection site was now black al around it. The reactions lasted for 11 days and sort of calmed down. The reporter consented to follow up.