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Vaccines, Blood & Biologics

Arthritis, Fibromyalgia, Alopecia Clinical Narratives

PID 123422- Rheumatoid Arthritis

AE# 1757

This 18 year old woman had a history of Juvenile Rheumatoid Arthritis since 2 years of age.  She received a single vaccination in September 04. In November 04 she complained of bilateral elbow arthralgia with edema.  She was treated with Sulindac, a non-steroidal anti-inflammatory drug. No further vaccinations were administered.  As of December 04 the patient was asymptomatic on medication. At a follow-up appointment in July 06, the patient reported taking Sulindac only as needed for pain, rather than daily, because of gastric upset. Additional lab results are on page 20/193 of this submission.


PID 123804- Alopecia Areata

AE# 13718

This 34 year old woman received a total of three doses of vaccine, the last in July 05. In January 06, she reported that since November 05 she had been experiencing significant hair loss with brushing/combing of her hair, especially over her right ear. On exam, a 1.5 cm circular patch of hair loss was noted over the temporal region. The patient was referred to a dermatologist who diagnosed Alopecia Areata, probably stress related.  Treatment consisted of intralesional injection of Kenacort.  At follow-up appointments in February and March 06, her hair was noted to be growing in. In May 06, the patient complained of some continued hair loss and associated nervousness/anxiety.  At a follow-up appointment in June 06, the alopecia was considered completely resolved. Additional lab results on page 47/193 of this submission. 


PID 216829- Rheumatoid Arthritis


This 21 year old woman was vaccinated in September 04 and October 04. In January 05, she complained of knee pain for the past 4 years.  She was initially diagnosed with Rheumatic Fever for which she was treated with three injections (one per week) of Benzetacil antibiotic. However, she continued with intermittent joint pain in her knees, elbows and wrists.  In February 06, she was seen by a rheumatologist who revised her diagnosis to Polyarticular Rheumatoid Arthritis.  She was treated with Prednisone, Plaquenil and Leflunomide and reported improvement in her symptoms on these medications.  At a follow-up appointment in August 06, the patient was following the treatment regimen and was asymptomatic. Additional lab results on page 60/193 and page 70/193 of this submission.


PID 229946- Rheumatoid Arthritis

AE# 11066

This 25 year old received a total of 3 doses of vaccine, the last in August 05.  In October 05, she presented with pain in her knees, elbows, wrists and fingers.  At that time she reported a family history of Rheumatoid Arthritis.  Work up showed a positive Rheumatoid Factor (1:16) and positive C Reactive Protein.  She was diagnosed with clinical findings of Rheumatoid Arthritis and was placed on Prednisolone and Indomethacin.  As of June 06, she reported she was feeling better on increased doses of meds.  Additional lab results on page 88/193 of this submission.


PID 294498- Fibromyalgia

AE# 7266

This 21 year old woman received two vaccinations, the last on February 05.  She has a history of asthma and spastic colon.  In June 05 the patient presented to the emergency room, with symptoms of fatigue, myalgia, and arthralgia of one month’s duration.  She noted that she was under a lot of stress at work.   She was hospitalized and evaluated by a rheumatologist who diagnosed Fibromyalgia.    The patient was discharged on Amitriptyline and Acetaminophen.  At follow up appointments in February 06 and June 06 the patient reported that she was doing better on her medications.  Additional lab results are on page 116/193 of this submission. 


PID 306043- Alopecia Areata

AE# 9226

This 24 year old woman received three doses of vaccine, the last on March 05.  In September 05 she complained of several months duration of round areas of hair loss.  On examination, a 3cm zone of alopecia was noted in the occipital region.  Continued hair loss was noted in March 06.  Otherwise, skin was normal.  In April 06 she saw a dermatologist who diagnosed Alopecia Areata.  She was treated with intralesional Triamcinolone (corticosteroid).  In June 06 regrowth of hair was noted.  The Alopecia was considered resolved in October 06.  Lab results page 145/193 of this submission.


PID 482958- Fibromyalgia

AE# 17155

This 22 year old woman received two doses of vaccine, the last on December 05.  Late in 05 the patient went to an orthopedist, complaining of pain in her wrists, and occasionally in her shoulders and toes.  She reports that the doctor diagnosed Rheumatoid Arthritis and gave her “shots” where there was pain.  In March 06 a Rheumatoid Factor was reported as positive (68).  In April 06 the patient reported she was still having pain and was prescribed an anti inflammatory medicine. ANA was positive at 1:40.  Additional test results are on pages 164-167 of this submission.  In May 06 Rheumatoid Factor result was 1:9.  The patient was prescribed Mobicox (NSAID) and Prexige (NSAID).  Valerpan, a corticosteroid, was administered by a doctor.  In June 06 IgG cardiolipin was weakly positive at 14.4.  In July 06 a rheumatologist reevaluated her variable pain and changed the diagnosis to Fibromyalgia.  She was prescribed Acetaminophen, Fluoxetine and Imipramine.  At follow up appointments in August and November 06, the patient reported significant improvement of symptoms on the medications.  Additional lab results are on page 193/193 of this submission.

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