Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Product complaint, Skin laceration, Wound secretion
Clinical narrative: This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a male patient who received SHINGRIX (batch number LT533, expiry date 10th November 2018) for prophylaxis. This case was associated with a product complaint. On 12th July 2018, the patient received the 1st dose of SHINGRIX. On 12th July 2018, immediately after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and allergic reaction. On an unknown date, the patient experienced wound oozing, laceration of arm, injected limb mobility decreased, activities of daily living impaired, pain in arm and pharmaceutical product complaint. On an unknown date, the outcome of the extensive swelling of vaccinated limb, wound oozing, laceration of arm, pain in arm and pharmaceutical product complaint were unknown and the outcome of the injected limb mobility decreased, activities of daily living impaired and allergic reaction were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, wound oozing, laceration of arm, injected limb mobility decreased, activities of daily living impaired, allergic reaction and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX in the left arm. Shortly after receiving SHINGRIX, the patient's left arm was doubled in size from shoulder to fingertips. The patient could not bend his arm and still could not bend it completely. He still could not put his wedding ring, watch or wear certain shirts because the sleeves were too tight. They have contacted the pharmacist who have administered the vaccine. The patient was seen by family physician and both have informed that the patient was having severe allergic reaction to vaccination and they could do nothing. Recently the patient's swollen arm split open about 3 inches and starting to ooze fluid. His arm was drained constantly for days and he has to continually blot the drainage. This drainage caused him embarrassment and kept him at home and curtailed his activities. The reporter asked that whether there were any reports of this severe reaction to the vaccination and how this arm could be restored so that the patient may resume his normal activities. The reporter asked for any remedy or medical advice. It was frustrating and worrisome as we wait for relief. The reporter requested to investigate production facility of lot number LT533 for contamination and to study the enclosed photos that substantiate which severe reaction. They had spent money for the vaccination and could not anticipate the future costs before the arm would be at normal size. They hope GlaxoSmithKline would give serious consideration to their concern. They requested for monetary consideration for patient's medical expenses, pain and suffering once his arm returns to normal. At the time of reporting time they were only giving notice of this severe allergic reaction and were looking for assistance in the patient's arm to be normal.