Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Confusional state, Decreased appetite, Diarrhoea, Discomfort, Dyspnoea
Clinical narrative: Initial information received on 28-Aug-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 61 years old female patient who experienced one episode of loss of consciousness, lymph nodes in her neck are 'pulsing", burning sensation to her entire body, numbness in her ankles and toes, chest heaviness and pressure, difficulty breathing, sweating, drop in blood glucose, pressure in her head, confusion, feeling "foggy", painful joints, loss of appetite, four pound weight loss, feels pressure in her neck on the right side from mid-throat to collar bone, "jabs of pain" in her feet and hands and calves and looser than normal stool, worsening headache, tingling and nausea while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccine concomitantly. On 15-Aug-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number U5898AA and Expiration Date 31-May-2020) in the left deltoid. On 25-Aug-2018, the patient developed a serious one episode of loss of consciousness, 10 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On unknown date, the patient developed a non-serious lymph nodes in her neck are 'pulsing", burning sensation to her entire body, numbness in her ankles and toes, chest heaviness and pressure, difficulty breathing, sweating, drop in blood glucose, pressure in her head, confusion, feeling "foggy", painful joints, loss of appetite, four pound weight loss, feels pressure in her neck on the right side from mid-throat to collar bone, "jabs of pain" in her feet and hands and calves, looser than normal stool, worsening headache, tingling and nausea following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Relevant tests were not reported. Final diagnosis was one episode of loss of consciousness, looser than normal stool, "jabs of pain" in her feet and hands and calves, feels pressure in her neck on the right side from mid-throat to collar bone, four pound weight loss, loss of appetite, nausea, painful joints, feeling "foggy", confusion, pressure in her head, drop in blood glucose, sweating, difficulty breathing, chest heaviness and pressure, numbness in her ankles and toes, burning sensation to her entire body, tingling, worsening headache and lymph nodes in her neck are 'pulsing". It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: None. Sender's Comments: This case involves a 61 years old female patient who presented with loss of consciousness post vaccination with ADACEL. Time to onset is compatible. However, patient's medical history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.