Sex: F
Vaccine: MENB, MNQ
Symptoms: Red cell distribution width normal, Syncope, Urine analysis abnormal, Urine ketone body absent, Urobilinogen urine decreased
Clinical narrative: Initial information received on 10-Aug-2018 regarding an unsolicited valid serious case received from other health professional from other manufacturer under reference number-2018196199. This case involves a 16 years old female patient who experienced passed out, loss of consciousness, flushed, fainting and lightheaded with primary diagnosis of orthostatic syncope and vaccination site pain while she received vaccine MENACTRA and TRUMENBA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. History reviewed. No pertinent past medical history. Reports that she has never smoked. She has never used smokeless tobacco. It was reported patient did not drink alcohol or use drugs. No pertinent surgical history. On 05-Apr-2018, the patient received a second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848AA via intramuscular route in the left deltoid at 3.30 PM. Patient also received TRUMENBA (Batch number: S56026, Exp date: 28 Feb 2019) intramuscularly in left deltoid on 05-Apr-2018 at 3.30 PM. On an unknown date, following the administration patient had flushing, syncope, dizziness and passed out with primary impression of orthostatic syncope. It was also reported Mom gave her candy bar and some water to drink. Later while shopping at a hardware store she got lightheaded again and once on the floor. There was no injuries as a result of this fall. Patient reports she feels lightheaded and flushed before the syncope. She denies chest pain or palpitations. She's had no recent nausea vomiting or diarrhea. She's had no recent fevers. Last menstrual cycle one week ago and she denies chance of pregnancy. She denies urinary symptoms. Patient denies any chronic medical problems. She feels normal at this time. She does report that the vaccination site in her right deltoid is extremely sore. Appropriate laboratory and radiology studies reviewed Patient presents to the emergency department secondary to 2 episodes of near syncope. She did receive some vaccinations earlier in the day. Laboratory evaluation in emergency Department unremarkable but patient was orthostatic. She was not symptomatic upon standing. It was also reported patient was orthostatic. Primary impression was orthostatic syncope. On an unknown date patient visited emergency department. Blood pressure 110/60, pulse 78, temperature 97.1 Fahrenheit (36.2 degree Celsius), temperature source Oral, resp. rate 14, height 5' 3.5" (1.613 m), weight 122 lb 6 oz (55.5 kg), last menstrual period 04/02/2018, Sp02 100 %. Constitutional: She is oriented to person, place, and time. She appears well-developed and well-nourished. Head: Normocephalic and atraumatic. Mouth/Throat: Oropharynx is clear and moist. B Eyes: EOM are normal. Pupils are equal, round, and reactive to light. Pulmonary/Chest: Effort normal and breath sounds normal. She has no rales. Musculoskeletal: Normal range of motion. She exhibits no edema. EKG: Sinus rhythm, rate 74, nonspecific ST-T wave changes, no acute ischemic changes. White blood cell (WBC) 9.9 4.0 - 11.0 x10(3)/mcl, RSC- 4.48 (3.80 - 5.10 x10(6)/mcl), Hemoglobin (Hgb) 13.6 12.0 - 15.6 gm/dl, Hematocrit (Hct) -40.4 (35.7 - 45.9 %), Mean corpuscular volume-(MCV) 90.2 (82.5 - 99.8 fl), MCH 30.4 (27.0 - 34.3pg), MCHC- 33.7 (32.1 - 35.3 gm/dl), ROW- 13.3 (11 .5 - 15.0 %), Platelet-101 (L) (144 - 423 x10(3)/mcl), MPV- 10.6 (6.8 - 10.8 fl), Neutrophil Percent 90.0 %, Lymphocytes Percent- 6.3 %, Monocytes Percent 3.5 %, Eos Percent 0.1 %, Basophil- Percent 0.1 %, Neutrophil- 8.9 (H) 1.8- 7.7 x10(3)/mcl, Lymphocytes- 0.6 0.6 - 4.8 x10(3)/mcl, Monocytes 0.0 - 1.3 x10(3). Sodium- 136 (136 - 145 mmol/L), Potassium- 3.6 3.5 - 5.0 mmol/L, Chloride- 100 (98 - 107 mmol/L), Total C02- 24 (22 - 29 mmol/L), Anion Gap- 12 (7 - 16 mmol/L), Calcium- 8.9 (8.4 - 10.2 mg/dl), Glucose Lvl- 124 (H) (60 - 100 mg/dl), BUN- 18 (5 - 18 mg/dl), Creatinine- 0.64 (0.51 - 1.30 mg/dl), HCG QUAL- Negative, UA Color- Yellow, UA Appear- Clear, UA Glucose- Negative, UA Ketones- Negative, UA pH- 6.0, UA Protein-negative, UA Urobilinogen- Normal, UA Nitrite- Negative, UA Mucus- 2+ /LPF, UA Mucus- Trace /LPF, UA Hyal Cast- 3 (H) (0 - 2 /LPF). Final diagnosis was passed out, loss of consciousness, flushed, fainting and lightheaded with primary diagnosis of orthostatic syncope and vaccination site pain. Patient had MINOCIN, DYNACIN (100mg) as corrective treatment. Patient was recovered from the events. The outcome of event vaccination site in her right deltoid is extremely sore was not reported. The reporter assessed the events as related to TRUMENBA. List of document held by the sender: None.