Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Induration, Injection site reaction, Mobility decreased, Pain in extremity, Ultrasound scan normal
Clinical narrative: From initial information received on 15/Mar/2005 from a registered nurse regarding an adverse event occurring, it was reported that a 53-year-old female patient received a booster dose of TD ADS ADULT, lot number U1279AA, administered intra-muscularly in the left deltoid on 25/Feb/2005 at 11:00AM.  Per the reporter, the injection was "a difficult give - she felt tight, but it was the fully accessible correct site".  She tolerated the injection well, but said it "hurt like the dickens".  On 28/Feb/2005 and 01/Mar/2005, the patient made no mention of any adverse events.  On 02/Mar/2005, she was seen in the office with a complaint of severe pain and was unable to mover her arm well.  At that time, there was no visible irritation at the site.  The patient was referred for medical follow-up.  Her recovery status was reported as "possibly in process".  Follow-up information received on 30-September-2005.  The patient was first seen by MD on 2-March-2005 due to discomfort from injection given on 25-February-2005.  The reporter mentioned the patient stated the symptoms started "in the evening."  The MD findings included full range of motion of neck, no tenderness along left trapeziums, no tenderness along the subacromial area.  Tenderness was noted along the local site in the deltoid with an area of induration and tenderness noted on deep palpation.  No local erythema, edema, soft tissue swelling or increased temperature noted at injection site.  Active abduction of shoulder joint was within normal limits, however pain was noted beyond 70-80 degrees.  Symptoms were suspect to secondary local inflammatory reaction, could not rule out sterile abscess.  No evidence of nerve impingement noted on exam.  Patient was advised on warm compresses to the area.  The patient was given Bextra samples 10mg twice a day for 9 days.  She was also prophylactically covered with antibiotics within Z-Pak 500mg daily for 3 days.  she was advised to return if symptoms continued.  The patient was seen again on 07-March-2005.  She had completed the antibiotics, and was still taking the Bextra.  She was unable to sleep for 2 nights due to pain and was also noticing pain and tightness in the neck area.  She denied any numbness or tingling along upper extremities or in her fingers.  She felt the injection site was tight and sore.  Clinical findings by the MD revealed essentially the same findings as the 2-March-2005 visit.  (The MD) continued to feel it was related to muscle inflammation.  She was given Vicodin 5/500mg 1-2 tablets every 4-6 hours for pain.  15 tablets were prescribed.  Also advised to continue to use warm compresses.  She was also given Norflex 100 mg, 2 times per day for 10 days.  She was also referred for Physical Therapy 2 times a week for 2 weeks.  Her physical therapy assessment was done 07-March-2005; their diagnosis was upper trapeziums spasm reaction to a tetanus injection.  The MD again saw the patient on 21-March-2005 after 6 sessions of Physical Therapy.  She continued to have local left deltoid inflammation.  Hematoma or deep sterile abscess still not ruled out.  Ultrasound ordered as a diagnostic and PT was continued for another 6 sessions.  She was given a refill on Bextra and Norflex along with being advised to use Tylenol.  An ultrasound was done on 22-March-2005 and was within normal limits.  The patient's 15th physical therapy treatment was 10-May-2005.  At that time she stated she was 99% improved since initial visit.  Sleep is now restful without medications.  She is able to perform work tasks, garden and perform "ADL's" as well as home activities pain free.  She never contacted them for further issues.  The Employee Health nurse spoke with her on 15-August-2005 and she stated she still has an occasional episode of her arm being sore and bothering her.  Follow-up information received on 27/Dec/2005 from a health care professional.  The patient is still experiencing occasional spasms.  No other information was provided.