Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a "normally very healthy" 33 year old white female non-smoker with a history of acute otitis media, caesarean section requiring hospitalization, and an allergy to clarithromycin (Biaxin) who on 25-Nov-2005 at 09:30 am was vaccinated in the right deltoid with an eighth dose of pneumococcal 23v polysaccharide vaccine (lot #A651319/1007P). Illness at the time of vaccination included bilateral maxillary sinusitis. The patient was hospitalized for cellulitis from 28-Nov-2005 to 29-Nov-2005. The patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been received from a physician's office. On 26-Nov-2005, the patient had localized redness and warmth at the injection site. As the day went on, the redness doubled in size and was painful. The patient had nausea and vomiting. She was treated with amoxicillin (+) clavulanate potassium (Augmentin), guaifenesin, nalbuphine hydrochloride (Nubain), promethazine hydrochloride (Phenergan), azithromycin (Zithromax), and levofloxacin (Levaquin). It was noted that the symptoms started on 26-Nov-2005 and required the patient to be hospitalized for one day. Medical records from the patient's hospitalization included a history and physical which indicated that the patient was seen by her family physician on 25-Nov-2005 for a "cold" and was diagnosed with an "upper respiratory infection and sinusitis." She was placed on oral amoxicillin (+) clavulanate potassium (Augmentin). The patient received her "first" dose of pneumococcal 23v polysaccharide vaccine and also received a yearly influenza vaccine in the left deltoid. The next day, on 26-Nov-2005, she noted some localized redness and warmth about the right deltoid, the site of the pneumococcal 23v polysaccharide vaccine. She was feeling worse as the day went on with pain and redness. She subsequently came into the emergency room for further evaluation and treatment. Upon arrival, her temperature was 38.8, pulse was 124, respirations were 20, blood pressure was 91/62, and her oxygen saturation was 100 percent on room air. It was determined that the patient had right arm cellulitis and that she would benefit from impatient IV antibiotics and care and was admitted to the hospital on 27-Nov-2005. In the afternoon of 27-Nov-2005, she was feeling "much better." She was started on IV sultamicillin (Unasyn) 3 gm Q6 hours. In the emergency room she had received nalbuphine hydrochloride (Nubain) IM 10 mg once and promethazine hydrochloride (Phenergan) IM once. The patient noted having had nausea and vomiting on 26-Nov-2005 and earlier in the morning on 27-Nov-2005. She had no further nausea and emesis since the emergency room injection. The patient state that her arm felt "a little sore" about the right deltoid but not anything severe. She was quite pleased on how much better she felt in the afternoon of 27-Nov-2005 compared to earlier that day. The medical record noted that she started amoxicillin (+) clavulanate potassium (Augmentin) on 25-Nov-2005 and had two doses and just one dose on 26-Nov-2005 and none since because she was too nauseated in the evening to take the second dose. She had been taking guaifenesin 600 mg since approximately 25-Nov-2005 and was sporadically using hydrocodone syrup since approximately 25-Nov-2005. She had a nonproductive cough. In the afternoon of 27-Nov-2005, she appeared well, alert, and oriented. Respirations were unlabored, 16 per minute and her pulse was 84. She had some grayish-green nasal drainage and similar postnasal drainage. Her pharynx had mild injection. She had a very red, warm and somewhat swollen right deltoid area. There was a black pen marker approximately 4 by 6 inches drawn out at the border. Laboratory studies from the emergency room revealed and 12 percent bands. Hemoglobin was normal at 12.6. Blood cultures times 2 were drawn. The assessment was right deltoid arm cellulitis and upper respiratory infection/sinusitis. The plan was to continue with sultamicillin (Unasyn). A progress note from 28-Nov-2005, indicated that her right arm felt better and was less painful. She believed the redness was moving down her arm. She had a little nausea on and off. An assessment revealed that her right lateral deltoid area was erythematous and was essentially at the same location by the pen markings except that it had move down distally. It was just slightly warm. The erythema was a dark dull red. The assessment with right lateral deltoid cellulitis versus severe local immune skin reaction to pneumococcal 23v polysaccharide vaccine. It continued to improve. She did well and gradually recovered as an inpatient. She was discharged late in the afternoon on 28-Nov-200k with an order for levofloxacin (Levaquin) 750 mg PO every day for 10 days, promethazine hydrochloride (Phenergan) 25 mg PO Q6H prn for nausea and acetaminophen (+) oxycodone hydrochloride (Percocet) 1-2 tabs PO Q4H as needed for pain. It was noted that she was inadvertently given azithromycin (Zithromax) 750 mg IV when the order was for levofloxacin (Levaquin) 750 mg. She was to follow-up on 29-Nov-2005 with her family physician. Cellulitis was considered to be another important medical event by the reporter (OMIC). Other business partner numbers included E2005-05574.