Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood urine present, Condition aggravated, Fatigue, Feeling drunk, Fluid retention
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 59-year-old male patient who received Herpes zoster (SHINGRIX) (batch number 99D9A, expiry date 15th May 2022) for prophylaxis. Co-suspect products included Herpes zoster (SHINGRIX) (batch number F4234, expiry date 30th April 2022) for prophylaxis and pregabalin (Lyrica) for tingling. Concurrent medical conditions included shingles (spot of shingles started to spread after the shots). On 18th July 2020, the patient received the 2nd dose of SHINGRIX. On 2nd May 2020, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient started Lyrica at an unknown dose and frequency. On 18th July 2020, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced drug use for unapproved indication. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, condition aggravated, tingling, fatigue, pain, numbness, unwell, blood in urine, feeling drunk and water retention. The patient was treated with vitamin B6 and cyanocobalamin (Vitamin B12). The action taken with Lyrica was unknown. On an unknown date, the outcome of the vaccination failure and drug use for unapproved indication were unknown and the outcome of the shingles, condition aggravated, tingling, fatigue, pain, numbness, unwell, blood in urine, feeling drunk and water retention were not recovered/not resolved. The reporter considered the vaccination failure, shingles, condition aggravated, tingling, fatigue, pain, numbness, unwell, blood in urine, feeling drunk and water retention to be related to SHINGRIX. The reporter considered the vaccination failure, shingles and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient self reported this case. The patient received 2nd dose of SHINGRIX and within 60 days (2 months) after the SHINGRIX shots had some tingling in two toes in each foot. The patient figured it was just fatigue but then when the tingling started spreading he asked for a referral to another physician. The patient first went to his regular physician and then was sent to a podiatrist. He was told that he needed (shoe) inserts. The pain, tingling, and numbness went from two toes to all five toes, then it went to the pads of his feet, then spread to his ankles. The patient only wore the shoe inserts for 2 days because they were so painful to wear and he quit wearing them. The patient went back to the podiatrist and then went to a neurologist and got electrocuted there then he went to a vascular physician and got all that checked out then he went back to the podiatrist. The patient had ultrasounds done from his knees to toes on the nerves and an MRI was performed and none of the physician could figure out what was going on with his legs. The patient believed that SHINGRIX was responsible. The patient also wanted GlaxoSmithKline to knew that he was not diabetic but he was given an unspecified diabetic medication for the treatment of the tingling but it made him ill and caused blood in his urine.  The patient also tried Lyrica for the treatment of the tingling, but that made him feel drunk and gave him water retention so he had to quit taking that. The patient said that nothing that the physician had tried had worked.  He had started on Vitamin B12 and Vitamin B6 and these events had not resolved. The patient stated, that he wanted to get better and that he wanted to be able to function. The patient stated that he could not even drive anymore because his vehicle was a stick shift. The patient also mentioned that he did not want to get the SHINGRIX shot but his doctor made him, which led to drug use for unapproved indication. The physician gave SHINGRIX because he had one little quarter spot of shingles and that started to spread after the shots, he started getting them in more different places. It was unknown if the reporter considered the feeling drunk and water retention to be related to Lyrica. An unspecified diabetic medication was also considered as co-suspect for adverse events blood in urine and illness. This case was considered as suspected vaccination failure since the details regarding completion of laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.