Reporte zur Charge U6014AB

Symptomtext

unable to complete daily activities; weakness in arms; neck pain; weakness in legs after flying; swelling of hands; whole body pain; whole body pain and weakness; Initial information on 26-Oct-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 73 years old female patient who was unable to complete daily activities, neck pain, weakness in legs after flying, swelling of hands, whole body pain, whole body pain and weakness and weakness in arms while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis. On 23-Apr-2019, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT at a dose of 0.5 ml (lot U6014AB, expiry date: 20-Jul-2020) via intramuscular route in the left deltoid for immunisation. On an unknown date the patient developed a serious unable to complete daily activities (loss of personal independence in daily activities) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. This event was leading to disability. On 25-Apr-2019 the patient developed a non-serious neck pain, weakness in legs after flying (muscular weakness), swelling of hands (peripheral swelling), whole body pain (pain), whole body pain and weakness (asthenia), 2 days following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. On an unknown date the patient developed a non-serious weakness in arms (muscular weakness), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Relevant laboratory test results included: C-reactive protein - On an unknown date: [heightened] Red blood cell sedimentation rate - On an unknown date: [heightened] No positive RA test Action taken: Not applicable. Steroids as corrective treatment was received for the events. Outcome: Recovering / Resolving for all the events.; Sender's Comments: Sanofi company comment dated 02-Nov-2022: This case involves a 73 years old female patient who was unable to complete daily activities, neck pain, weakness in legs after flying, swelling of hands, whole body pain, whole body pain and weakness and weakness in arms while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac]. Additional information regarding condition at the time of vaccination, risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.