Age: 71.0
Sex: M
Vaccine: TD
Symptoms: Infection, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Muscle spasms
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from a patient on 11/28/2005. A 72 year old male patient received a lest arm injection of TD ADS Adult, lot number U1022AA, 1/12/2005, after stepping on a nail and injuring his left foot. Route of administration was not reported. Eight days later, the patient developed left arm swelling, had spasms of the arm and Tics and hand tremors. He was examined by a physician. An electrocardiogram was performed although date and results were not provided. Per existing medical conditions were reported as none, and other medications include aspirin daily. Per the reporter, the spasms continue. At the time of this report, the patient had not recovered. The reporter indicated that the event was previously reported to VAERS. Follow up information received on 1/3/2006 from a physician. The patients initial injury was a nail puncture wound of the right great toe. TD ADS adult was administered intramuscularly into the left deltoid. On 1/20/2005, the patient was examined and was complaining of swelling of the left arm beginning five days post vaccination. He had developed a 5cm diameter tender erythema and swelling over the left lateral upper arm which was assessed to be hypersensitivity reaction to tetanus injection. He had also developed an infection at the nail puncture wound site which had resolved following seven days of Keflex therapy. The patient also complained of heartburn beginning on 1/19/2005, and this was assessed to be secondary to GERD. He was prescribed Benadryl 50 mg as needed for itching or swelling of the left arm. Upon examination on 2/25/2005, the patient complained of body spasms that began on 1/20/2005 and were described to his physician as muscle spasms of the right thigh, left arm, episodic tremors of the hand and neck spasms which at times made it difficult to swallow. He had also experienced occasional pains in his chest. During the assessment of 2/25/2005, the patient was diagnosed with episodic tremors and muscle spasms, status post tetanus booster. He had no tremors at that time and a normal motor exam of the extremities. A serotonin level was ordered at the patients request, and the patient was referred to a neurologist. Per the report, the patient has recovered. Follow up information received on 1/26/2006 from a physician. The patient has a history of a Brown Recluse spider bite at the right ankle in 7/2004 and an oozing ankle lesion and folliculitis of the right lower leg in 10/2004. He also had a history of chest pain secondary to esophagitis and gastroesophageal reflux wit a good response to Protonix. Chest pain was removed by the physician as an adverse event, and heart burn has been removed due to the patients history of heart burn secondary to GERDS reported in the physicians progress note on 1/20/2005. On 1/20/2005, an ECG was normal, and a CBC was normal other then elevated eosinophils at 11%. A comprehensive metabolic panel was also normal. The patient was examined by a neurologist on 3/2/2005. At that time he had no muscle weakness, numbness or tingling, double vision or loss of balance. The symptoms of swelling and pain in his left upper arm and spasms in his legs had been resolved for the past week. The impression of the neurologist was mild myalgia syndrome that seems resolved. Per the patients initial report, dated 11/28/2005, the spasms continue and he had not recovered. Follow up information received on 2/27/2006 from a physician. Per the reporter, the patient was seen one time in his office as a consult on 3/2/2005 and he has not seen him anymore. No further information is expected from this source. Documents held by sender, Patients progress notes dated 1/12/2005, 1/20/2005 and 2/25/2005. Additional office notes for 2004-2005. 3/2/2005 Neurology consult.