Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Productive cough
Clinical narrative: Initial report was received on 18 January 2011 from a health care professional. This case represents one of a cluster of 4 patients from the same reporter, same vaccine, same lot number, and who experienced adverse events requiring emergency room visits after receiving FLUZONE HIGH-DOSE on different dates. One patient was hospitalized. Information regarding the patient who was hospitalized is reported in case number 2010-01674; and information regarding the last 2 patients are reported in cases 2011-00303, and 2011-00252. A 72-year-old female patient had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot number U3605BA) on 25 October 2010. That evening after receiving the vaccination, the patient experienced a productive cough with yellowish thick phlegm. She had bruising on the left side of her ribs, which the patient felt was due to coughing. It was not mentioned that the patient required an emergency room visit, however the patient was seen in the clinic 1 week later on 02 November 2011 and was treated with antibiotics for bronchitis. Past medical history includes: actinic keratosis, atrial fibrillation, chronic systolic CHF (congestive heart failure), nocturnal leg cramps, DJD (degenerative joint disease) of the knee, hypothyroidism, glossopharyngeal neuralgia, obesity, osteopenia, allergic rhinitis (NDS), "spell" (Not specified), vitamin B12 deficiency, and is positive for long term use of anticoagulants and high risk medication. Concurrent medications at time of vaccination included: LANOXIN, Levothyroxine, Metoprolol, Omeprazole, Sertraline, and WARFARIN. Per the reporter, it is unknown if the patient recovered. Follow-up information received from a health care professional on 25 January 2011 reported that the patient was not ill at the time of vaccination, had no adverse event following prior vaccination and had no other vaccines within 4 weeks of the FLUZONE HIGH DOSE. She had received three previous doses of flu vaccine in the past. The patient received an intramuscular injection of FLUZONE HIGH-DOSE, lot number U3599AA. The patient reported that she experienced dizziness, nausea and abdominal pain that night. The patient also developed coughing (previously reported as shortness of breath, chest tightness and chest pain). The outcome was reported as recovered. Follow-up information was received from a health care professional on 23 February 2011. The patient was evaluated in the clinic for a cough that started the evening of her flu vaccine. The coughing was to the point of bruising her ribs. She was treated on 02 November 2010 with antibiotics and ROBITUSSIN AC. The diagnosis of bronchitis was made by auscultation of the lungs and observation of signs and symptoms (s/s). The patient was seen on the 23 December 2010 for follow-up and she had no mention of the date of recovery. The outcome remained recovered. Follow-up information was received from the health care professional on 11 March 2011. The exact date of recovery was unknown, per the reporter; it was noted that symptom were still ongoing as of 02 November 2010, but had resolved by 23 December 2010.