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Administered by: Private Purchased by: Private
Life Threatening? Yes
Write-up: Information has been received from a 39 year old female consumer with allergies to bees and amoxicillin (+) clavulanate potassium who on 10/31/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine in the right arm. Concomitant therapy included montelukast sodium and Ester dial patch. By the afternoon on 10/31/03, her right arm began to swell from her shoulder to a little below the elbow. She says that her arm was so swollen that she could not move her right arm or do her daily routine. The pain was so intense that she was unable to move. She felt that she was going to die. Her daughter in law''s father is a physician who told her to take an antihistamine, which did not work. In the morning of 11/1/03, her arm was very swollen three times its normal size and she had a fever, headache and nausea. As of 11/03/03, her arm was still swollen and she was still complaining of a headache. She also reported that she had a raised white spot on her arm. She reported that her physician is a friend of hers and he is already aware of her situation. Unspecified medical attention was sought. There was no product quality complaint involved. On 11/6/03 the nurse reported that they had no information to add. The patient''s events were considered to be immediately life threatening and disabling. Additional information has been requested. A 15-day follow up report received 12/10/2003 adds: Follow-up info received 11/25/2003 from the nurse indicated that on 10/31/2003 at 3 PM, the pt experienced redness, swelling and discomfort in the IM site which lasted for 5 days. The pt recovered and her events were not considered to be life-threatening or disabling by the reporting health care professional. The pt considered her events to be immediately life-threatening and disabling. No further info is expected.
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