Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Myositis, Sleep disorder, Tenderness
Clinical narrative: Initial report received from a healthcare professional on 15 November 2012. A female patient, whose age, date of birth and concomitant medications were not reported and who had no known allergies or illness at the time of vaccination, had received an intramuscular dose of FLUZONE (lot number: UH731AB) in the right deltoid on 08 October 2012. On 10 October 2012, 2 days after the vaccination, the patient developed headache, right shoulder pain and weakness to fingertips. Corrective medications and laboratory investigations were not reported. At the time of this report, the patient had not recovered. Follow-up information was received from a healthcare professional on 10 April 2013. The reporter for this case is also the same as for cases 2012-10730, 2013-00362, 2013-00363, and (2013-00361, which was found to be a duplicate). Upon receipt of follow-up information a healthcare professional on 10 April 2013, it was determined that this case is a duplicate of case number 2013-00361. All information has been included in reference case number 2012-10829 and the duplicate case 2013-00361 will be deleted. The duplicate case 2013-00361 information included: On an unspecified date, the patient experienced unspecified "symptoms post flu shot". Based upon the new information provided, this case has been upgraded to serious. The patient, a surgical technician (tech) was 27-years-old at time of immunization and onset of adverse event. She was 28-years-old at date of examination by doctor. Onset of experienced symptoms post flu shot was reported as 09 October 2012, one day post vaccination, the patient experienced pain and tenderness of right (R) trapezius, suprascapularis, deltoid, biceps and triceps muscles (previously reported as 10 October 2012). The patient was seen by physician on 20 November 2012. According to reporter Physician's Notes, she developed pain/tenderness on R side of neck to shoulder, pectorals, intercostals, extending down into hip, same side as flu shot given, R deltoid on 08 October. Symptoms began next day with headache (HA), also involved weak R hand. On 14 November 2012, the patient called physician and TYLENOL Arthritis two (ii) every (Q) 8 hours (hr) was prescribed with no help and Ibuprofen was prescribed (no dose, route or frequency reported) with result of mild decrease in pain, three to four hours. She complained of being fatigued, can not sleep as usual (on front), but able to work full shifts. The exam was limited as no exam table in RN Office. The patient's gait and station were reported as normal. the R deltoid had no cellulitis. She had full range of motion (ROM at major and minor joints, but tenderness of trapezius, suprascapularis, deltoid, biceps and triceps on R. She had no tenderness to palpation (TTP) on left (L), thorax and R hip were not tender. Assessment and Plan (A/P) were reported as post flu shot myositis, with no evidence of infection. The duration of symptoms and muscle tenderness were reported as unusual, but likely to respond to Prednisone, prescribed as 40 milligram (mg)/day times (x) five days, with no refills. Other treatments included: over the counter (OTC) BENADRYL 25 mg each bedtime x 10 days; Amitriptyline 10-20 mg each bedtime x 10 days; followed by acetaminophen 650 mg, two every eight hours (hrs), discontinued on 05 December 2012; and switched to OTC Motrin. Per Physician's Notes, she had "not done a 'ROII', needs to." On 04 February 2013, the patient was diagnosed with R trigeminal (trigem) neuralgia. The patient had a past medical history (PMH) on 31 July 2012 of pain, right (R) shoulder (acromioclavicular (A-C) joint and scapula) and left (L) sternoclavicular (S-C) joint, reported as apparently self-limited. At the time of the report, according to the reporter, no laboratory or diagnostic tests were performed. The stop date of symptoms was reported as still symptomatic on 15 February 2013. The later course of Prednisone was reported as also of no benefit, as was Amitriptyline intended to help her difficulty sleeping. The patient did not come for visit on 22 March 2013, nor did she call to cancel; physician did not plan any further follow-up. The patient's outcome remained not recovered, reported as "not yet". List of documents held by sender: Medical Records.