Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Irritability, Liver function test increased, Malaise, Memory impairment
Clinical narrative: On August 9, 2018, a 59 year old female received MassBiologics' Td vaccine (Lot #A110A) in her upper left arm at an urgent care center for wound management; patient had a metal puncture wound under her right toe thumb nail. That day, the patient took her routine medication Atorvastatin 10mg. The patient was prescribed KEFLEX by the urgent care center for her wound. During Td administration the patient reported a burning feeling at the injection site and immediately felt "goofy", weak, and nauseous; and reported body aches, headache, upset stomach, diarrhea, and energy depletion the day after administration. On August 12, 2018, the patient returned to the urgent care center due to her symptoms and the facility performed an Influenza A test to which the patient tested positive. A review of the patient's medical records from the 8/12 visit indicated the patient presented with cough, chills, fever, fatigue, malaise, abdominal pain, generalized weakness, and sore throat. The patient was prescribed TAMIFLU 75mg. On August 13, the patient was seen at the urgent care center for a rash on the right side of her abdomen. That night, the patient indicated that she had slept for fourteen hours and upon waking up, she reported left arm pain and small "knots" and bruising on her left forearm. On August 15, the patient again returned to the urgent care center and medical records indicate she presented with gastrointestinal symptoms; the healthcare provider did not observe any nodules on her left forearm. The patient was prescribed Ondansetron for nausea, Meloxicam for arm pain, and Omeprazole to protect stomach lining from the Meloxicam. The patient went back to the urgent care center for follow-up on August 18 and August 24, with no change in symptoms. On 8/24 she was referred to an Infectious Diseases Specialist for further evaluation due to her ongoing malaise and fatigue. The patient contacted MassBiologics on August 21 to make an initial report for this event. The patient called back on August 22, to report some follow-up information and indicated that she was experiencing a swollen belly, abdominal pain, and heartburn/indigestion. The patient also reported canker sores in her mouth that had developed a few days post Td administration. MassBiologics contacted the patient on August 29 for follow-up. The patient indicated that she was now experiencing numbness in the fingers on her right hand and was having trouble breathing. The patient also reported that at a recent doctor's visit, it was noted that her heart rate has increased since receiving Td. On October 9, MassBiologics contacted the patient for follow-up and the patient reported the following new symptoms: elevated liver levels, feet swelling, finger numbness on both hands, decreased concentration and retention of memory, and grouchiness; the patient also indicated the occurrence of hot flashes since Td administration. In addition, the patient reported that she was still experiencing the following symptoms: weakness/depletion of energy, trouble breathing, headaches, and joint achiness. The patient confirmed that her arm pain and rash had resolved and indicated that she was no longer experiencing any other previously reported symptoms. It is unclear if the patient sought medical treatment for the new symptoms reported. Sender's Comments: Adverse events reported in this ICSR were compiled from the patient's direct report to MassBiologics and from the patient's medical records.