Age: 72.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Pain, Post herpetic neuralgia, Scar, Skin ulcer, Swelling
Clinical narrative: pain, life" has stopped, spine, buttocks, thigh, groin, and hip; shot has debilitated him; numbs; groin area is (currently) swollen; scars all over his legs from the (shingles) lesions; Shingles has damaged his body; his "life" has stopped/He cannot wear underwear or pants due to this; severe case of shingles, been in the hospital; post-herpetic (neuralgia) nerve damage; sores; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included aortic aneurysm (10 years ago). Previously administered products included Shingrix (received 1st dose on an unknown date, the reporter was not sure of the date of first dose of Shingrix but it was also given at that same doctor's office). Concurrent medical conditions included diabetes.   On 30th November 2021, the patient received the 2nd dose of Shingrix and Influenza vaccine. On 1st December 2021, 1 days after receiving Shingrix and Influenza vaccine, the patient experienced shingles (serious criteria hospitalization) and post herpetic neuralgia (serious criteria hospitalization). On an unknown date, the patient experienced pain (serious criteria hospitalization), weakness (serious criteria hospitalization), numbness (serious criteria hospitalization), groin swelling (serious criteria hospitalization), scar (serious criteria hospitalization), skin ulcer (serious criteria hospitalization), general physical health deterioration (serious criteria hospitalization) and activities of daily living impaired (serious criteria hospitalization). The patient was treated with gabapentin (Neurontin (Gabapentin)), analgesic, nos (Pain Medication), vitamin B substances nos (B-Complex), lidocaine and dermatologicals nos (Ointment). On an unknown date, the outcome of the shingles and post herpetic neuralgia were resolved with sequelae and the outcome of the pain, weakness, numbness, scar, general physical health deterioration and activities of daily living impaired were unknown and the outcome of the groin swelling was not recovered/not resolved and the outcome of the skin ulcer was recovered/resolved.   The reporter considered the shingles and post herpetic neuralgia to be related to Shingrix and Influenza vaccine. It was unknown if the reporter considered the pain, weakness, numbness, groin swelling, scar, skin ulcer, general physical health deterioration and activities of daily living impaired to be related to Shingrix and Influenza vaccine.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's comment: This case was reported by the patient's wife. The patient received second dose of Shingrix into unknown arm and a unspecified Flu (Influenza) vaccine in the other arm at the same time and one day after vaccination the patient came down with a severe case of shingles. The sores lasted 2 weeks. Less than a year, Since then the post-herpetic (neuralgia) nerve damage and pain had been so intense that patient's life had stopped. The reporter said that the Shingrix shot had debilitated him. (The reporter wanted GlaxoSmithKline to knew that Shingrix could cause serious side effects). Since the first week of December, the patient had seen many doctors including his primary care physician, pain management specialists and a neurologist. The patient had taken pain medications, B-Complex, Lidocaine and Neurontin/Gabapentin. The Neurontin/Gabapentin did not touch his pain and numbed him. The reporter stated that the shingles pain started in patient's lower spine and it followed along the nerve (line) affecting the right buttocks, the right thigh, the inside of the right groin, and the right hip. The patient's right groin area was (currently) swollen and could hardly touch it. The patient could not wear underwear or pants due to this. Topical ointments helped for only about 2 hours.  The patient also had scars all over his legs from the (shingles) lesions he had. Shingles had damaged his body. The patient had also been in the hospital. The patient was currently under the care of a different primary care physician now. The reporter did not have any lot numbers. The shots were given at the patient's previous doctor's office and the contact information was given regarding that office which should had the lot numbers on file. (The reporter was not sure of the date of first dose of Shingrix but it was also given at that same doctor's office). The reporter consented to follow up.