Sex: M
Vaccine: TDAP
Symptoms: Muscular weakness, Paraesthesia, Product used for unknown indication
Clinical narrative: Weakness in legs; Weakness; Weakness, numbness, pins/needles, difficulty ambulating, chest pain, SOB; pins/needles; difficulty ambulating; chest pain; SOB/increasing in severity with shortness of breath; Product used for unknown indication; This serious case was reported by a consumer and described the occurrence of weakness in a 44-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9935H, expiry date 03-JUL-2024) for prophylaxis.   Concomitant products included lisinopril and gabapentin (Gabentin).   On 03-JUL-2024, the patient received Boostrix (intramuscular, left deltoid) .5 ml. On 13-JUL-2024, 10 days after receiving Boostrix, the patient experienced weakness (Verbatim: Weakness) (serious criteria hospitalization and clinically significant/intervention required), numbness (Verbatim: Weakness, numbness, pins/needles, difficulty ambulating, chest pain, SOB) (serious criteria hospitalization and clinically significant/intervention required), pins and needles (Verbatim: pins/needles) (serious criteria hospitalization and clinically significant/intervention required), walking difficulty (Verbatim: difficulty ambulating) (serious criteria hospitalization and clinically significant/intervention required), chest pain (Verbatim: chest pain) (serious criteria hospitalization and clinically significant/intervention required) and shortness of breath (Verbatim: SOB/increasing in severity with shortness of breath) (serious criteria hospitalization and clinically significant/intervention required). On an unknown date, the patient experienced lower extremities weakness of (Verbatim: Weakness in legs) (serious criteria hospitalization) and product used for unknown indication (Verbatim: Product used for unknown indication). The outcome of the weakness, numbness, pins and needles, walking difficulty, chest pain and shortness of breath were not resolved and the outcome of the lower extremities weakness of and product used for unknown indication were not reported.   It was unknown if the reporter considered the weakness, numbness, pins and needles, walking difficulty, chest pain, shortness of breath and lower extremities weakness of to be related to Boostrix.     The company considered the weakness, numbness, pins and needles, walking difficulty, chest pain, shortness of breath and lower extremities weakness of to be unrelated to Boostrix.   Additional Information: GSK Receipt Date: 09-SEP-2024 The reporter reported that a patient received Boostrix vaccine and experienced weakness, pins/needles, difficulty ambulating, chest pain, shortness of breath. The patient was hospitalized. The patient received lisinopril, Gabentin, s/p intravenous immunoglobulin. The symptoms was started less than 2 weeks after the vaccine was administered. The patient also experienced weakness in legs, increasing in severity with shortness of breath. The patient went to the emergency room and admitted to hospital. The diagnosis of Guillain-barre syndrome, Lumbar puncture, labs done. The intravenous immunoglobulin given for five days and discharged. The symptoms was worsened and went to in intravenous immunoglobulin initially started then discontinued because neurologist did not think it was Guillain-barre syndrome. The weakness and inability to walk was continued.; Sender's Comments: Asthenia is a listed event which, due to the following criteria (long TTO) is considered unrelated to GSK vaccine Boostrix.  Hypoaesthesia, Paraesthesia, Gait disturbance, Chest pain, Dyspnoea  and Muscular weakness are unlisted events which are considered unrelated to GSK vaccine  Boostrix.