Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Somnolence, Vaccination failure, Viral infection, Wrong product administered
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received BOOSTRIX (batch number 42PT4, expiry date unknown) for prophylaxis. The patient's past medical history included human bite. Concomitant products included povidone-iodine (Betadine). In September 2018, the patient received BOOSTRIX. In September 2018, 1 day after receiving BOOSTRIX, the patient experienced cellulitis (serious criteria GSK medically significant), difficulty breathing, nausea and wrong vaccine administered. On 6th December 2018, the patient experienced viral infection, nasal congestion and chronic fatigue. In December 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), fever, enlargement of lymph nodes, decreased appetite and sleepiness. On an unknown date, the patient experienced feeling abnormal. The patient was treated with bronchodilator (nos) (Bronchodilator) and cough cold preparations nos (Cough Syrup). On an unknown date, the outcome of the vaccination failure, nasal congestion, fever, enlargement of lymph nodes and wrong vaccine administered were unknown and the outcome of the whooping cough, difficulty breathing, viral infection, chronic fatigue, decreased appetite and feeling abnormal were not recovered/not resolved and the outcome of the cellulitis was recovering/resolving and the outcome of the nausea and sleepiness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, whooping cough, difficulty breathing, viral infection, nasal congestion, nausea, chronic fatigue, fever, enlargement of lymph nodes, decreased appetite, feeling abnormal and sleepiness to be related to BOOSTRIX. The reporter considered the cellulitis to be unrelated to BOOSTRIX. Additional details were received as follows: The patient received BOOSTRIX following a human bite in emergency room. Shortly after it was cleaned with betadine and washed thoroughly. The next morning, the patient couldn't breathe when she woke up and felt like she was going to throw up. She did develop cellulitis at the site of the bite. About 4 weeks back from the date of reporting, the patient developed an illness at the same time as her family member. The family member recovered from the illness quickly, but the patient still felt terrible. When the illness started she could not breathe through her nose and she felt like she was going to throw up. She was extremely fatigued and slept for about 3 days. After about 3 weeks she felt like the virus finished incubating.  The patient developed a fever of 101 degree F and a terrible cough, like whooping cough. For 2 days, when the cough was at its worst, she could cough so hard that she was unable to breathe. A bronchodilator did not help, but she has had some benefit from cough syrup. Her pharmacist told her that the bronchodilator did not work because the problem was with swollen lymph nodes and not her lungs. Her appetite was low and she felt horrific for the past 4 weeks. She had seen physicians twice for this illness and felt like she suffered from chronic fatigue. She slowly felt better, but still feels terrible, fatigued and out of breath. The patient thought that the virus she had was made worse by her receiving Tdap instead of just a tetanus vaccine, which led to wrong vaccine administered. She was sensitive to medications and vaccines and only wanted tetanus, but only BOOSTRIX was available when she was vaccinated. The reporter consented to follow up. This case was considered as suspected vaccination failure since the primary vaccination schedule, confirmatory laboratory test and time to onset for the target disease were unknown at the time reporting.