Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Eczema, Phototherapy, Rash
Clinical narrative: Eczema; Rash all over body; This is a serious spontaneous case, initially received from a physician on 04-Dec-2018, concerning a 16-year-old, adolescent male patient.  The patient's historical condition included eczema, anaphylactic shock due to tree nuts, sesame and figs and had a lot of allergies and sensitivities. The patient was on eczema diet protocol and eczema had cleared up. The patient's current condition included asthma (since an unspecified date). The patient had no egg and drug allergies. Concomitant medications included Advair (fluticasone propionate, salmeterol xinafoate) and Zyrtec (cetirizine hydrochloride; as needed) for unknown indications.   On 14-Oct-2018 at 02:52 pm, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252676 and expiry date: 30-Jun-2019] for influenza prophylaxis. Reporter was not sure if it was from MDV (multi-dose vial) or a PFS (pre-filled syringe).  On 16-Oct-2018, reported as couple of days after vaccination, the patient experienced rash all over his body. At first, the reporter thought that it would recover but it got worse and worse. On 17-Oct-2018, 3 days after the vaccine (as reported), the patient developed eczema. The patient went to see an allergist and a dermatologist during these events, and they were told that, couple of more days and the patient would to be hospitalized. On an unspecified date in 2018, the patient underwent phototherapy and was treated with Prednisone for two and half weeks. It was confirmed that the patient was not hospitalized. The patient's mother reported that eczema had not completely resolved, but mostly it had. It was slowly getting better.  On an unspecified date in Nov-2018 (reported as over the week of 19-Nov-2018), the patient had recovered from the event (rash all over). The outcome of the event eczema was recovering (slowly getting better).  Follow up received from the reporter on 28-Dec-2018: The reporter confirmed that the patient took Zyrtec prior to the events (frequency: as needed) and hence added Zyrtec as historical drug instead of concomitant medication. It was reported that the patient had a lot of unspecified allergies and sensitivities and the reporter wondered whether vaccines contained glutamates. Added eczema as historical condition and the patient was on eczema diet protocol which cleared up later. Added new event eczema. It was confirmed that the patient was not hospitalized. Narrative was amended accordingly.  Follow up received from consumer (mother of the patient) on 04-Jan-2019: Updated outcome of the event eczema from not reported to recovering. It was reported that, contact information previously given was all that the reporter wanted to give. Added Med-info number (SEQ19-00078) in the additional information tab. Narrative was amended accordingly.; Reporter's Comments: A 16-year-old male patient with medical history (unspecified allergies/ sensitivities and eczema) experienced rash all over his body, 1 day 9 hours after Flucelvax QIV vaccine and eczema, 2 days 9 hours post vaccination. Considering the plausible temporal relationship between vaccination and reported events, the plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event (rash all over) as serious (medically significant).