Age: 0.15
Sex: M
Vaccine: DTPHIB, FLUX, MNQ, PNC
Symptoms: Abscess drainage, Antibiotic resistant Staphylococcus test positive, Blood calcium normal, Blood creatinine normal, Blood culture negative
Clinical narrative: Initial report received on 22 Apr 2010: This patient was enrolled in a study. The patient's past medical history included a family history of diabetes type 2 (grandfather) and stroke (grandfather). The patient received MENACWY conjugate vaccine on 30 Sep 2009, 28 Nov 2009, and 27 Jan 2010. The patient received concomitant vaccines DTAP-HIB-IPV on 30 Sep 2009, 28 Nov 2009 and 27 Jan 2010, HBV pediatric/adolescent on 18 Jul 2009, 30 Sep 2009 and 30 Jan 2010, H1N1 on 27 Jan 2010, and 13 Mar 2010, influenza vaccine 'pres' free on 30 Jan 2010, PREVNAR on 30 Sep 2009, 28 Nov 2009 and 27 Jan 2010, and ROT5 on 30 Sep 2009, 28 Nov 2009 and 27 Jan 2010. on 20 Apr 2010, the patient presented at an emergency room with a sudden onset of swelling in the left inguinal region. The patient's parents reported that the patient had been well the previous day (no known fever) and that morning except for a diaper rash. The patient had exhibited increasing fussiness and swelling was noted when the patient's diaper was changed. Ten days previously the patient had experienced a viral syndrome with fever (for 5 days), followed by a full body, fine pin point rash; the patient received TYLENOL, and the condition had resolved without problems the previous week (considered non-serious by Novartis medical safety physician). Upon examination the right groin area was without erythema or oedema, the left groin area had a large inguinal mass (non pulsatile) with a large amount of oedema and erythema (7cm x 5cm) the area was tender on palpation, indurated and firm, no fluctuance appreciated and the penis was not involved. The patient had erythema of the buttock region with small papules, the area was warm to touch. An ultrasound performed at the ER revealed soft tissue and subcutaneous fat oedema and irregular fluid pockets, fluid collection appeared complex, and it was reported that an incision and drainage may be necessary for a cure. No peristaltic bowel was seen to demonstrate a hernia. The patient had enlarged palpable nodes (adenitis). A diagnosis of left inguinal abscess and left groin cellulitis was made, and it was stated that 'it was likely from a necrotic node'. The ultrasound findings indicated that incision and drainage may be necessary for a cure. The patient was admitted for parenteral antibiotics and probable incision and drainage. The patient received ROCEPHIN and VANCOMYCIN in the ER. Addition hospital medications included, XYLOCAINE, Saline bacteriostaic, Lidocaine cream, sodium chloride, electrolyte, acetaminophen, DESTIN, Ceftriaxone, baby ibuprofen. The patient had a temperature of 101.5C, blood pressure of 106/83, pulse of 150, respiration rate of 20 and oxygen saturation of 97%. Results from a blood culture was negative. The patient had a white blood count of 19.7K/ul. It was reported that the abscess was not yet mature for drainage, and the patient continued on intravenous antibiotics and warm compresses to the area. At the time of reporting the patient's condition was considered recovered with sequelae. The investigator assessed that the event of left inguinal cellulitis was not suspected to be related to study vaccine but that the left inguinal abscess was possibly related to study vaccine. Follow up received on 27 Apr 2010: The patient had a history of left groin swelling and there appeared to be a deep suppurative lymph node abscess. On 23 Apr 2010, the patient underwent an incision and drainage of the inguinal abscess. The fluid was cultured and sent for anaerobic and aerobic cultures. The investigator reported that the drained fluid from the surgery site grew Methicillin-resistant Staphylococcus aureus (MRSA). The patient tolerated the procedure well and on 25 Apr 2010, the patient was discharged from hospital with oral SULFATRIN and FLURA-DROPS. Follow-up received 06 May 2010: The underlying cause of the left inguinal abscess was lymph node abscess from MRSA. The necrotic node and adenitis were confirmed. The patient was hospitalised from 20 Apr 2010 until 25 Apr 2010. The patient's condition was improving from the left inguinal abscess, left groin cellulitis, necrotic node and adenitis. The patient had completely recovered from the viral syndrome. The investigator did not suspect a relationship between the viral syndrome and the study vaccine. The investigator suspected a relationship between the left inguinal abscess, the lymph node abscess from MRSA and necrotic node and the study vaccine. The investigator reassessed the event left groin cellulitis as possibly suspected to be related to the study vaccine. Follow-up received on 19 May 2010: The patient made a complete recovery from left inguinal abscess and left groin cellulitis on 08 May 2010. The investigator stated that the left inguinal abscess had resolved with some residual palpable scar tissue. Follow up received on 27 May 2010: The batch review for this case was recorded with reference number 111589. Following internal review on 27 May 2011 the following correction was made: Abscess drainage was deleted as an event and entered as a procedure.