Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood culture negative, Blood urea decreased, Chest X-ray normal, Clostridium test negative, Culture urine
Clinical narrative: Initial report received from healthcare professional via other manufacturer on 10 September 2014. This is a report from a study. An 18-year-old female patient had received intramuscular single booster dose of MENACTRA (batch number and anatomical site of administration were not reported) on 23 June 2014. The patient received first dose of open label study drug (225 mg) subcutaneously on 20 June 2014 (every 28 days). It was unknown whether or not the subject received placebo or active study drug in this past study. The patient has a Medical history included ulcerative colitis from October 2011 and Grave's disease from 2008. The patient's concomitant medication included ENTOCORT 3 mg, caps, 2 capsules orally every morning from 16 March 2014; oral calcium citrate capsules from 19 March 2013 at one 1200mg capsule daily; oral Vitamin D3 capsules from 19 March 2013 at 50,000 IU capsule weekly; oral FLORASTOR capsule from 26 November 2013 at 250 mg twice a day; oral mercaptopurine capsules from 07 September 2013 to 2 July 2014 at 25 mg (1 dose cap) daily; and oral LIALDA capsule from 14 January 2014 at 4.8 g, caps; 1:2 g caps, 4 capsules daily for ulcerative colitis. It was reported that on 25 June 2014, 2 day after receiving MENACTRA vaccine, the patient serious adverse events of left pleuritic pain, fever, Viral syndrome, Myalgia, Neck Stiffness, and Headache. The corrective treatments and laboratory investigations were not reported. The patient's corrective treatment included pain management TORADOL, morphine, and ZOFRAN, IV fluids, and decreased environmental stimuli. The patient was discharged from the hospital on 28 June 2014. She was seen in the emergency room on 26 June 2014, where labs, urinalysis, and Chest X-ray were performed. She was admitted 26 June 2014 through the emergency room with left sided pleuritic chest pain, headache, neck stiffness, fever, and myalgia lasting 5 days. On 27 June 2014 subject's cerebrospinal fluid red blood cell (RBC) count was 258 u/L. On 29 June 2014 results of a complete blood count (CBC) included RBC count of 3.79 u/L, neutrophil count of 77.9%, lymphocyte count of 10.2%, absolute neutrophil count of 8.6 u/l, and monocyte count of 1.2 u/l. Also on 29 June 2014, the blood urea nitrogen was 4 mg/dl. On 27 June 2014, Chest x-ray and UA both were within normal limits and Chest X-ray: Normal, Comments: No evidence of acute cardiopulmonary disease; Urinalysis/Urine culture: positive ketones, Comments: less than 1000 CFU/ml. On 26 June 2014, Blood culture: Normal, Comments: No growth; C. diff toxin: Normal, Comments: Negative; Fungal culture: Normal, Comments: No growth; Rotavirus antigen (26Jun2014): Normal, Comments: Negative. On 15 July 2014, the outcome was recovered. The investigator assessed that "L pleuritic pain" was not related to clinical trial procedure. The investigator assessed there was no reasonable possibility the Viral syndrome, Myalgia, Neck Stiffness, Headache, Fever, and Left sided pleuritic chest pain were related to study drug or clinical trial procedure, but were related to concomitant drug Meningococcal vaccine. The investigator provided the causality of SAEs Myalgia; Neck stiffness; Left sided pleuritic chest pain; Fever; and Headache were related to concomitant drug MENACTRA. Documents held by sender: none.