Age: 1.76
Sex: M
Vaccine: FLU4
Symptoms: Vaccination complication, Viral infection
Clinical narrative: Based on followup information received on 20 March 2015, this case became medically confirmed. Initial unsolicited report received  from a non-healthcare professional on 13 November 2014. A 21-Months-old male patient, whose medical history and concomitant medications was not reported, had received a second intramuscular dose of FLUZONE QIV (Batch number U5064AB, expiry date 30 Jun 2014) in the left thigh, on 08-NOV-2014. On 08-NOV-2014, 1 day after vaccination the patient had a bluish lump in his groin area on the vaccine side. The patient had gone to the ER and an ultrasound and blood work was done. The patient was diagnosed with a viral illness and an enlarged lymph node. The patient had received antibiotic as a precaution. Again at visit to physician the patient was diagnosed with a shot reaction and told her to stop antibiotics and that the lymph node will take 4 to 6 weeks to resolve. The patient's illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as none. The patient required ER visit. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow up information received from a physician on 20 March 2015. On 25 September 2014 the patient was prescribed fluticasone 0.05% cream to be applied by topical route twice daily for 7 days for flares of eczema and Multi-Vitamin with Fluoride 0.25 mg/mL oral drops 1 ml every day orally on 17 October 2014. The patient had no relevant medical history. The patient did not have any known drug allergy and patient never had overlying erythema, warmth or tenderness to the area and has been without fever. It was reported that one day after prior to the appearance of the lump in the left groin region, patient received the annual flu vaccine in the left thigh. On Sunday evening, parents noted the lump in the groin area and presented. The patient was treated with Augmentin for suspected lymphadenitis and antibiotic but no change to the area in size of lymphadenopathy and antibiotic was stopped immediately. The patient's vaccination history included intramuscular dose of Dtap (batch number- N5339, expiry date - 25 March 2016 and manufacturer- Glaxo Smith Kline) in left thigh on 12 August 2014, DTAP-HEP B-IPV (Batch number-25 March 2016 and manufacturer- Glaxo Smith Kline) in left thigh on 12 August 2014, DTAP-HEP B-IPV (Batch number- M3475, expiry date- 11 October 2015) on 07 August 13, DTAP-HEP B-IPV Batch number- BC75T, expiry date- 06 September 2015) on 05 June 2013, DTAP-HEP B-IPV (Batch number- AC21B408AA, expiry date- 22 January 2015) on 2 April 2013, ACTHIB (Batch number- UH835AA, expiry date- 04 November 2014) on 03 June 2014. ACTHIB (Batch number- UH847AA, expiry date- 26 November 2014) on 07 August 2013, ACTHIB (Batch number-UH847AA, expiry date-28 November 2014) on 05 June 2013, ACTHIB (Batch number-UH773AA, expiry date-20 June 2014) on 02 April 2013, intramuscular dose of HEPATITIS A PEDIATRIC VACCINEN (hep a, ped/adol) (Batch number- 4AS3K, expiry date-24 January 2014 and manufacturer-Glaxo Smith Kline) in left thigh on 12 August 2014, 0.25 ml intramuscular dose of FLU QIV (Batch number- U5064AB, expiry date-30 June 2015) in left thigh on 08 November 2014, FLU QIV (Batch number- U4779AA, expiry date-30 June 2014) on 18 December 2013, (Batch number-U4767AA, expiry date- 30 June 2014) on 07 November 2013 of same vaccine, MMR II (Batch number-J008154, expiry date-08 July 2015) on 03 June 2014, Pneumococcal conjugate pcv 13) (Batch number-H75732, expiry date-03 September 2015) on 12 February 2014, (Batch number-G69332, expiry dare-30 August 2014) on 30 August 2013, (Batch number-G43219, expiry date-30 July 2014) on 05 June 2013, (Batch number-G68911, expiry date-30 October 2013) on 02 April 2013 of same vaccine, DTAP-HEP B-IPV (Batch number-M3475, expiry date- 11 October 2015) on 07 August 2013, (Batch number-BC75T, expiry date-06 September 2015) on 05 June 2014, (Batch number-AC21B408AA, expiry date-23 January 2015) on 02 April 2013 of same vaccine, ROTAVIRUS, TETRAVALENT (Batch number-H016250, expiry date- 27 March 2014) on 07 August 2013, (Batch number-H015682, expiry date-15 March 2014) on 05 June 2013, (Batch number-H011456, expiry date-27 November 2013) on 21 April 2013 of same vaccine, VARICELLA (Batch number-J007679, expiry date-13 June 2015) on 12 February 2014. Other laboratory investigations include evaluation of the groin lump which included blood work (CBC WNL for age) and on 13 November 2011 at 9:04:00 Temperature: 97.4 Fahrenheit temporal artery (36.33 degree Celsius). At the time of report outcome of events were unknown. Documents held by sender: none. Follow-up received from a healthcare professional on 23 April 2015. Patient had a medical history of eczema. No other information reported.