Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Acquired diaphragmatic eventration, Anaphylactic reaction, Back pain, Chest X-ray abnormal, Chest discomfort
Clinical narrative: Report received from a healthcare professional on 14-SEP-2010. This case was initially reported to Merck (WAES number: 1009USA3334). A 40 year old female patient received AFLURIA (batch 09949121B, expiry 15-JUN-2011) on 14-SEP-2010 12:00 for immunisation. The patient's medical history included diabetes. Concomitant medications included metformin and simvastatin. The patient was not pregnant at the time of vaccination. The patient had no known allergies. On 14-SEP-2010, after administration of the suspect drug, the patient experienced an anaphylactic reaction and was treated at Urgent Care Clinic at a local hospital. The patient started feeling itchy 5 minutes post vaccination.  Subsequently, she experienced pruritus primarily localised to her arm 15 minutes after administration of the suspect drug. She then experienced a spreading of cutaneous pruritus and a feeling of pharyngeal constriction. She also felt 'something in throat' and worsening of 'throat tightness'. The patient was noted to have cutaneous erythema in the extremities and torso with pruritis. There was no chest pain or shortness of breath. There was no head symptoms, no cardiovascular symptoms, no pulmonary symptoms, no gastrointestinal symptoms, no musculoskeletal symptoms. On 14-SEP-2010, the patient's vitals were BP (blood pressure) between 118/94 and 160/80, HR (heart rate) between 70-109, RR (respiratory rate) between 15-17, SpO2 on room air 98-100%. The patient was treated with intravenous fluids and was treated with three doses of epinephrine, 50mg of intravenous diphenhydramine, dexamethasone, 2mg of lorasepam and 20mg of famotidine. The patient was not admitted to hospital. She was discharged home with oral methylprednisolone and hydroxyzine hydrochloride on the same day (14-SEP-2010 15:00). She was also prescribed with intramuscular epinephrine for allergic emergency. The patient was considered to have recovered from the anaphylactic reactions on 14-SEP-2010. On 15-SEP-2010, the patient returned for a follow-up. She was found to have mild pain (pain scale 2/10) in the chest and back with inspiration and scratchy voice. The patient's lungs were CTA (clear to auscultation). The patient was itching a little and still had sensation of foreign body in throat with chest tightness but no shortness of breath and no rash. The patient had a headache. The patient was scratching at her left neck often and also clearing her throat every few seconds. The patient had no cardiovascular symptoms, no gastrointestinal symptoms, no musculoskeletal symptoms and no skin symptoms. The patient's vitals were BP 137/79, HR 86, RR 17, temperature 97.5 degrees F, SpO2 98%. On 15-SEP-2010, a chest x-ray showed mild elevation of the right hemidiaphragm, of unknown duration. Otherwise unremarkable chest with no definite evidence for acute cardiopulmonary disease. The case outcome was unknown, the event outcome of feeling itchy, headache, 'something in the throat', chest tightness, scratchy voice and pain with inspiration were unknown. Other events were recovered. The   [Due to memory limitations, the remainder of this text could not be compared.]  patient's friend also reported the patient was sick last year four days after administration of H1N1 vaccine. She was diagnosed with pneumonia. This case is documented in WAVES: 2010026457. The reporter considered events to be serious. The patient required treatment in the emergency room. The patient required medical/surgical intervention to prevent serious criteria. Information derived from this AE report does not change the current safety profile of the product. Follow-up (07-DEC-2010): additional adverse events, time of suspect drug administration, onset time, event description, treatment medications, event outcome. Correction on 20-DEC-2010. The overall casse listedness was changed from 'expected' to 'unspected' on 07-Dec-2010 when follow up information was last received.