Sex: M
Vaccine: TDAP
Symptoms: Steroid withdrawal syndrome, Urinary tract infection, Urine ketone body present, White blood cells urine positive
Clinical narrative: Passed out; Pain all over body; Unable to stand on feet; Extreamly cold; brain MRI indicated lacunar infarct; anaphoratyc shock; Fall; Overdose; could not get up; This serious case was reported by a consumer via other manufacturer and described the occurrence of lacunar infarction in a 45-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel) for prophylaxis.   The patient's past medical history included cognitive disorder (on 27-MAR-2020), ministroke, difficulty breathing, chronic anxiety, gastrointestinal disorder (the patient was treated with fentanyl and epidural corticosteroid injection), hyperaldosteronism, blood disorder, gastrointestinal disorder, neurological disorder nos, shortness of breath, panic attack, fungal infection, urinary tract infection, chronic back pain, chest pain and corticosteroid withdrawal syndrome (on 11-JUN-2021). Previously administered products included Bupivacaine HCL (on 27-FEB-2020), Methylprednisolone (on 27-FEB-2020 and stopped on 08-APR-2022) and Lidocaine. Concurrent medical conditions included heart disorder and drug allergy (Fentanyl,Bupivacaine, glucocorticoids, Flu , COVID-19 Moderna ,methylprednisolone, Opiods-Meperidine and polyethelene Glycol Analogues, preservative free Tdap). Concomitant products included fentanyl, colecalciferol (Vitamin D3), magnesium, fish oil, levomefolic acid (Methylfolat), baclofen and amlodipine;benazepril.   In JUN-2021, the patient received Boostrix and Adacel. On 14-JUN-2021, less than a week after receiving Boostrix, the patient experienced anaphylactic shock (Verbatim: anaphoratyc shock) (serious criteria GSK medically significant) and fall (Verbatim: Fall). In JUN-2021, the patient experienced overdose (Verbatim: Overdose). On 27-DEC-2023, the patient experienced lacunar infarction (Verbatim: brain MRI indicated lacunar infarct) (serious criteria GSK medically significant). On an unknown date, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant), general body pain (Verbatim: Pain all over body), difficulty in standing (Verbatim: Unable to stand on feet), mobility decreased (Verbatim: could not get up) and cold (Verbatim: Extreamly cold). The outcome of the lacunar infarction, anaphylactic shock, passed out, fall, general body pain, difficulty in standing and cold were not reported and the outcome of the mobility decreased was resolved (duration 2 hrs) and the outcome of the overdose was unknown.   It was unknown if the reporter considered the lacunar infarction, anaphylactic shock, passed out, fall, general body pain, difficulty in standing, mobility decreased and cold to be related to Boostrix.     The company considered the lacunar infarction to be unrelated to Boostrix. The company considered the anaphylactic shock and passed out to be related to Boostrix. It was unknown if the company considered the fall, general body pain, difficulty in standing, mobility decreased and cold to be related to Boostrix.   Additional Information: GSK Receipt Date: 31-OCT-2024  The patient experience mini strokes symptoms, chest pain, hypersensitivity, breathing and shortness of breath, blood disorder, severe anxiety and panic attack, fungal and urinary tract infection, gastrointestinal problem, chronic pain syndrome, blood test revealed high creatine kinase 534 u/L On 11th June 2021, while the patient was experiencing glucocorticoid withdrawal symptom, fungal infection, urinary tract infection, neurological disorder, blood test revealed eosinophilia, trace blood, ketones, light protein, leukocytes esterase in my urine test. The physician decided to order a register nurse to inject the patient with Tdap (Adacel with boostrix) vaccine, which led to overdose. On 14th June 2021, the patient suffered anaphylactic shock and a big fall while attempted riding his bicycle, during a family visit the patient passed out while the patient was to talk to his son and when the patient woke up and the patient felt pain all over my body. The patient could not stand on his feet and quickly laid down on the floor where the patient could not get up for almost two hours. The patient felt extremely cold as if the patient was experiencing thyroid disorder. On 2nd March 2022, regardless to reporting to be allergic to all corticosteroids and opioids, the patient was treated along with fentanyl and epidural corticosteroid. While reporting severe chest pain, hypersensitivity due to hyperaldosteronism, blood disorder, gastrointestinal and nervous disorder. The reporter reported to be allergic to these drugs and being ignore by pain managements. It was unknown if the reporter considered the lacunar infarction, anaphylactic shock, passed out, fall, general body pain, difficulty in standing, mobility decreased and cold to be related to Adacel.; Sender's Comments: Lacunar infarction and Loss of consciousness are unlisted events which are considered unrelated to GSK vaccine Boostrix.                                            Anaphylactic shock is a listed event which is considered related to GSK vaccine Boostrix.