Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram normal, Expired drug administered, Hypersensitivity, Injection site erythema, Injection site inflammation
Clinical narrative: This report was received from an agency and was assigned manufacturer report number 7108599 for REBIF. Information has been received from a physician and the patient concerning a 45 year old female with multiple sclerosis, nerve pain, headache, depression, tobacco abuse, spasms and chronic pain and a history of cellulitis who on 01-DEC-2011 was vaccinated with 0.5 ml dose of PNEUMOVAX 23 (lot # 671553/1138AA, expired on 06-OCT-2009). Secondary therapy included REBIF (lot # AU001935), 4 mcg three times a week by subcutaneous injection from 24-MAY-2011 to ongoing for multiple sclerosis and FLUVIRIN (lot number 1102601 and expiration June 2012). Concomitant therapy included TOPAMAX, 100mg, twice a day for headache, gabapentin, 300 mg, twice a day for nerve pain, ZOLOFT, 200mg, once a day for depression and ZANAFLEX, 2 mg, once a day for spasms. On 01-DEC-2011 the patient went for a routine physical and received PNEUMOVAX 23 in her right arm. On 02-DEC-2011 the patient went to the emergency room due to an allergic reaction where the arm of the patient swelled in the area of the PNEUMOVAX 23 and it was hot, red and inflamed. The patient was admitted to the hospital over night when the pain was going to her shoulder blade and in her chest. During the hospitalization the patient had laboratory tests which were negative for cardiac issues and blood cultures that were negative. The patient also had an ultrasound of the upper right arm that was negative for clots. The patient had serial cardiac and electrocardiogram and they ruled out a myocardial infarction. The symptoms were felt to be non-cardiac in etiology and most likely musculoskeletal in relation to her recent PNEUMOVAX 23. The patient received no treatment while at the hospital. On 03-DEC-2011 the patient was sent back to the emergency room by her physician because the arm was getting worse. The patient was given intravenous vancomycin in the emergency room for right arm cellulitis. The patient then had an allergic reaction with hives and her whole body was itching. The patient was given BENADRYL and antibiotics to prevent her from getting cellulitis. The top of the head of the patient has become spontaneously very itchy since the allergic reaction. The patient reported that she noticed itching of the tip of the head which began in August 2011. The patient continued administrations of REBIF. The patient was discharged from the hospital on 03-DEC-2011 with FIORICET 50/325 twice a day and VICODIN 10/325 daily as needed for pain. The patient had recovered from allergic reaction, right arm cellulitis and allergic reaction to vancomycin. Additional information received from a physician on 27-JAN-2012 included medical confirmation event details, discharge medications FIORICET, VICODIN, additional suspect medication FLUVIRIN and an additional serious event (right arm cellulitis). The physician assessed the relationship between allergic reaction and right arm cellulitis and REBIF as suspected and considered PNEUMOVAX 23 as a suspected causal factor. This was originally reported by a consumer. Additional information has been requested.