Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin abnormal, Dermatitis, Immune system disorder, Pruritus, Rash erythematous
Clinical narrative: This is a spontaneous case, reported by a physician and initially received on 31-Aug-2018, concerning a 19-year-old, adult female patient. The patient's vaccination history included a flu vaccine every year since she was 2 years old (with no adverse events) for unknown indication and asthma in periods which is currently in good control without medication. On 19-Aug-2018 (in the morning), the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left upper arm, batch number: YF36505, expiry date: 16-May-2019] for an unknown indication. On the same day, early in the evening after vaccination, the patient developed itchy red skin rash and began developing itchy pustules on her skin. On an unspecified date in Aug-2018 (reported as last weekend), after the patient went back to her college, she was seen by a nurse practitioner in the student health center and was referred to a dermatologist, who did a biopsy of her pustule and which was subjected to deoxyribonucleic acid (DNA) analyses and it revealed viral exanthema. The health professional had requested the medical information, which included test results. It was reported that, most of the skin lesions of the patient seemed to be healing. But there were two clusters of lesions on her leg. The patient also had an appointment with dermatologist on 10-Oct-2018. The patient visited 3 different dermatologist and underwent several biopsies of the skin lesion and analysed by histology. They revealed massive subdermal inflammation but no infection. The dermatologist suggested that skin lesions represent a case of severe adverse innate immune system reaction to the adjuvant in your vaccine. 7 months after vaccination, there was no new lesions but dark spots on the patient's skin where lesions have healed and two places where pustules are still elevated. At the time of this report, the patient had not recovered from pustule, recovering from erythematous rash, itchy rash, itchy, immune-mediated adverse reaction and viral exanthema. The patient recovered with sequelae from the event skin lesions. The reporter assessed this case as non-serious and the events as related to the suspect vaccine. Follow up received from the reporter on 10-Oct-2018: Added vaccination details (anatomical location, route of administration, batch number, and expiry date), added biopsy result. Amended narrative accordingly. Follow up received from a physician on 26-Nov-2018: Added the patient's historical condition asthma in the patient tab. Added two events skin biopsy abnormal and pruritus in the event tab. The case level outcome was changed from recovering to unknown. Added VAERS ID (770430) both in the product tab and additional information tab. Upon internal review it was realized that the company causality for the events pustule, viral exanthema, unspecified and skin lesion was incorrectly captured. Hence, it was changed from related to not related. The narrative and case comment were amended accordingly. Follow-up received from other non-health professional on 26-Mar-2019: This case got upgraded from non-serious to serious. Skin biopsy was added under lab data in the patient tab. Events immune-mediated adverse reaction skin and biopsy abnormal were added in the event tab. The outcome of the event skin lesion was changed from recovering to recovered with sequelae and the outcome of the event rash pustular was changed from recovering to not recovered in the event tab. Causality of the event 'skin lesion' was changed from 'not related' to 'related' in the event assessment tab. Reference numbers (Med Info Number: SEQ18-04026 and SEQ19-01174) were added in the additional information tab. The narrative and case comment were amended accordingly. Reporter's Comments: A 19-year-old female patient developed erythematous rash, itchy rash, pustule and skin lesion, on the same day after vaccination with AFLURIA QUADRIVALENT. The patient was eventually diagnosed with severe adverse innate immune system reaction and viral exanthema. The diagnosis was confirmed by abnormal skin biopsies. Considering the plausible temporal relationship between the event and suspect vaccine, the causal role of suspect vaccine cannot be ruled out. Hence, the company assessed the causality of the event severe adverse innate immune system reaction as related to the suspect vaccine. The company assessed the causality of the events viral exanthema as not related considering infectious (viral) nature of the event and inactivated suspect vaccine. The company assessed the case as serious (medically significant).