Age: 50.0
Sex: F
Vaccine: MU, MU
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist and a pharmacy tech concerning a 50-year-old female patient with no pertinent medical history, allergies or previous drug reactions, who on 28-JAN-2008 was vaccinated in the right upper arm with a dose of Mumpsvax II (659616/1982U) (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  Concomitant therapy included TYLENOL, ROCEPHIN, VICODIN, NALOXONE and "afzavelrd".  On 02-FEB-2008 the patient experienced nausea, vomiting, headache, light headedness, fever and cough which lasted 4-5 days.  On 06-FEB-2008 the patient developed swelling and pain of the right upper extremity at the injection site, and the left lower extremity was swollen.  On 08-Feb-2008, the patient was admitted to the hospital with a diagnosis of cellulitis and vomiting.  She developed respiratory failure, and became septic, likely due to necrotising and vomiting.  She expired after shock and cardiac arrest on 08-Feb-2008.  The cause of death was fasciitis.  During the hospital stay, the patient was treated with "promethezone", "NS" and "zolprclam".  The adverse events were classified as type A (pharmacological) reaction.  Naranjo's Algorithm for Determination of Probability was used to assess the adverse drug reaction, and scored a 2 which indicated that they were a possible reaction to the Mumpsvax II (Jeryl Lynn).  The adverse event appeared after administration of the vaccine.  The vaccine was not detected in the blood or other fluids in concentrations known to be toxic.  It was not known if the patient had a similar reaction to Mumpsvax II (Jeryl Lynn) or similar vaccines.  According to Schumocks Criteria for Preventability, it was not considered preventable.  The Mumpsvax II (Jeryl Lynn) was not inappropriate for the patient's condition.  The dose, route, and frequency of administration was not inappropriate for the patient's age, weight, or disease state.  There was no required therapeutic drug monitoring necessary or lab tests required.  There was no reported drug interaction.  A toxic serum of the drug concentration was not documented and there was no poor compliance involved.  No product quality complaint was involved.  The reporter considered the adverse events to be an other important medical event and life threatening.  A lot check has been initiated.  Additional information has been requested.  02/25/2008 Autopsy Report received with the following findings:  1) Abscess, Left Upper Lobe of Lung. 2) Apparent Cellulitis, Right Upper Extremity. 3) Congestion and Edema, bilateral Lungs. 4) Pleural Effusion, Left side.  5)  Congestion, Liver.  6) Mild Coronary Artery Atherosclerosis. 7)  Mild Atherosclerosis, Aorta. 2/27/2008 Tag2 received. 4/21/08 Initial report received from coroner. The deceased developed a high fever x 4 days s/p mumps vax for which pt did not seek treatment. On 2/8/08 pt developed severe pain in arm and leg, and began spitting up blood and was brought to the ER. Pt was admitted to the ICU at 930 am. At 1512 pt went into cardiac arrest and was prounounced dead after CPR was unsuccessful.  Attending MD stated victim most likely died of sepsis or severe infection. 07/08/2008 Remainder of Autopsy report received. Final COD Abscess, Left Upper Lobe of Lung (Days).  Other significant conditions:  Mild Subcutaneous inflammation, skin of Right upper extremity.