Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Insomnia, Intensive care, Leukocytosis
Clinical narrative: Information has been received from an attorney regarding a 31 year old female who presented to a physician on 25-NOV-2009 with a complaint of stuffy nose, sore throat, and headache. The patient thought she was developing a sinus infection and requested treatment. The physician indicated that the patient was "not sick enough" to receive medication because she had not experienced the symptoms for a long enough period of time. After the patient reminded the physician that her spleen had been removed in May 2004 due to injuries sustained in a motor vehicle accident, and that when she got sick she got "really sick," the physician recommended a pneumonia shot after determining the patient had not had one since 1995. The physician's medical assistant administered a dose of PNEUMOVAX 23 (Lot #663889/0632Y, expiration date 12-NOV-2010), subcutaneously in the patient's left arm. That night, the patient had trouble sleeping due to a bad headache, body aches, stuffy nose, and sore throat. On the morning of 26-NOV-2009, her left arm was sore. Later that day she developed chills and felt warm to the touch. She lay down for the afternoon during which time the pain persisted and the injection site turned more red and swollen, an area of about 1 inch in diameter. That evening, the patient noticed area was increasing in size. On 27-NOV-2009, after another virtually sleepless night in pain, the patient's head and neck were in such excruciating pain that she went to an urgent care facility. She had a fever of 103.9 and was advised to go to the emergency room because the urgent care physician feared she may have meningitis and they could not do bloodwork. The patient was admitted to the hospital with diagnoses of left arm cellulitis, leukocytosis out of proportion to degree of infection, symptoms of meningismus-rule out meningitis, and hypotension, 92/54. An infectious disease doctor was called in to manage the patient's care. CT scans and MRIs were negative for intracranial abnormalities. The patient was transferred to the ICU because the red, swollen, painful area where the vaccine had been administered continued to worsen and grow. The patient underwent a spinal tap to rule out meningitis. On 02-DEC-2009, the patient was released from the hospital. She continued to experience severe headaches that restricted her to her bed in a painful, highly emotional and depressed state. She was unable to provide the usual loving care to her three young children and husband, nor was she able to enjoy her usual activities for a significant amount of time. Information was received from a lawyer in the form of medical records concerning a 31 year old female with seasonal allergic rhinitis and a history of left tibia fracture status post motor vehicle accident in 1994 (conflicts with above date), pelvic fracture (1994), and splenectomy (1994) (conflicts with above date), who on 25-NOV-2009, was seen for a complaint of possible sinus infection. She had a 2-3 day history of cold symptoms, sore throat the previous night, nasal congestion, runny nose, and ear popping; no fever or cough; headache with pressure over the sinuses; she took no medications yet, and she had a seasonal flu vaccine. Her temperature was measured at 99.4 degrees F, temporal. Impression: upper respiratory infection. Rapid strep, group A culture was negative. The physician ordered another strep, group A and a pneumococcal vaccine, adult. The patient was administered a dose of PNEUMOVAX 23 (Lot #663889/0632Y, expiration date 12-NOV-2010), subcutaneously in her left arm. A physician called upon to provide an expert opinion indicated that there was no doubt that the patient had a severe (rare) potentially life threatening event following PNEUMOVAX 23 (Lot #663889/0632Y, expiration date 12-NOV-2010). The signs and symptoms with which the patient presented to the emergency room within 48 hours of immunization were consistent with Overwhelming Post splenectomy Infection (OPSI). The patient had a severe adverse reaction to PNEUMOVAX 23 characterized by adverse local reaction, cellulitis, signs, symptoms, and laboratory suggestive of septicemia, signs and symptoms of meningitis, meningismus, early signs and symptoms consistent with Overwhelming Post Splenectomy Infection, the spatial relationship between vaccination and the development of adverse severe life threatening symptoms within 24 to 48 hours. All available medical records will be provided upon request. Additional information has been requested.