From initial info received on 10/16/03 from a health care professional regarding an adverse event. It was reported that a 43 year old female pt received her fourth dose of TD ADS ADULT, lot U0518AA, administered IM in the left deltoid on 4/12/02 at approximately 3 pm. The pt received TD ADS ADULT due to a dog bite injury to her face. No tetanus immunoglobulin was given at that time. On 4/16/02 at 11 am, the pt developed dizziness, muscle spasms to her face, extremities, and neck, SOB, and the inability to speak or swallow. She was diagnosed with tetanus. Treatment included tetanus immunoglobulin and metronidazole. She was admitted to the hospital and was transferred to a different hospital on 4/17/02. She remained hospitalized until 5/6/02. The pt recovered from these events. From additional info received on 11/17/03 from a health care professional the medical records of the pt were provided. It was reported that the pt was admitted on 4/16/02 with tetany like muscle spasm, having suffered a dog bite to the left cheek some four-and-a-half days prior. The wound was infected and she was treated with antibiotics. The pt had not had a booster shot in 15 years, prior to the dog bite. The dog belonged to her and had all the immunizations required including a rabies booster shot later fall. On 4/16/02 she was given a prescription for Levaquin to be added to her treatment. She was at the drug store when she had marked spasm of the muscles of the throat and mouth and face and was not able to talk or swallow and felt SOB. She came to the ER and this improved somewhat spontaneously. The pt had never this before. The pt continued to demonstrate symptoms of tetany. Oral cavity: The pt still had some spasm of the muscles around the jaw and could only open her jaw about 4cm. Neck: Muscles slightly tight, no meningeal signs. Neurology: Extremity motor and sensory function was normal. The pt answered questions appropriately, but had trouble talking because she could not open her jaw all the way. The pt was treated with Levaquin, Flagyl and IV fluids. She was also given human tetanus immunoglobulin, Ativan and pain medicines when needed. Tetany continued but she did not have any respiraotry embarrassment. The pt was transferred to another hospital on the service of an infectious disease specialist. Transfer diagnosis was "Tetanus infection" and "muscle spasm due to tetanus." Phone call was made to second hospital for additional records. Message left to obtain needed follow up info. Follow up on 01/09/04: "From additional information received on 12/29/03 from the second hospital, the pt's consultation reports (date of consulation: 04/17/02, 04/18/02, 04/19/02) and history and physical were received.  It is thought that she had not had a tetanus booster for at least 15 years prior to her bite.  The dog was definitely known to have had his rabies booster last fall.  The dog involved was a pet of her family and was being monitored for rabies.  During consulation in the hospital, it was noted that she has had a low-grade fever.  The facial laceration was well healed on admission and the sutures were in place.  She did not have swallowing problems, seizures, numbness or tingling.  She could talk, but her speech was mumbled.  The cranial nerves were intact, however she could not stick out her tongue because of her mouth tightness. She was diffusely weak.  Sensation appeared to be intact to light tough and temperature.  Her tone was generally normal and reflexes were 1+.  Her toes seemed to be upgoing bilaterally.  She was able to move her arms and legs.  The impression was presumed tetanus.  She was given 250 units of human tetanus immune globulin and started on IV Flagyl, along with Levaquin.  She was placed on a liquid diet and monitored closely in case she had difficulty breathing.  She developed muscle spasms which seemed to involve the face and masseters, then her arms and legs.  She was given Ativan, which helped.  Prior to transfer she was receiving Ativan 1 mg.  as often as every 15 minutes.  On admission to the second she was able to open her mouth to about 4cm., but later was only able to pen her mouth to less than 1 cm.  She was given another 500 units if human immune globulin and was placed on IV Ativan, IV Dilaudid for pain control of her headaches.  She was able to talk when she had Ativan on board, but not when she was having episodes of trismus.  There was discussion of the possibility of a tracheotomy.  Examination revealed a blood pressure of 133/94, pulse 98, respirations 16.  There was symmetric chest wall expansion and her diaphramatic function was good.  There was no stridor.  Extraocular movements were intact with mild nystagmus on lateral gaze.  Pupils were equal, round and reactive to light and accomodation.  She had decreased facial movements and mild rigidity of the face.  There was no evidence of psychiatric disorders int he past and non one with homicidal intent to give her strychnine as far as the family members can tell, and no evidence of suicidal intent.  The following is the assessment from the physician: "This woman has trismus or this is psychiatric, which I doubt.  I doubt rabies; there is no hydrophobia here.  I doubt strychnine poisoning." The plan was to give IV fluids to help her avoid insensible loss and IV Protonix.  She was also given a Demerol PCA pump to control pain as well.  No other information was provided.  No further information is anticipated, this case is considered closed."