ICHICSR 2.2 1 fb169864-e6cf-2d87-1971-389a4bcfc054 BEST-Pilot ZZFDA 204 20210107165737 1 BEST_fb169864-e6cf-2d87-1971-389a4bcfc054 102 20210107 1 1 2 2 2 2 2 2 102 20210107 102 20210107 2 2 BEST_fb169864-e6cf-2d87-1971-389a4bcfc054 2 admin@admin.com 1 BEST-Prototype 2 FDA Office of Surveillance and Epidemiology FAERS 10903 New Hampshire Avenue Silver Spring MD 20993 US faersesub@fda.hhs.gov CM 102 19990624 1 801 5 2 NI Allergic transfusion reaction 23.0 10066173 102 20000101 102 20190120 19.05 801 1 E7003-ISBT (Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container) 102 20020109 2 3992-MULTUM (Epinephrine) 102 20020109 2 3498-MULTUM (Diphenhydramine) 102 20020109

Header: FDA CBER BEST Automated AE Reporting Prototype Case BEST Detection Phenotype Algorithm: Phenotype link: rules-cd BEST Certainty: Definite BEST Severity: Severe BEST Imputability: Probable Form Type: 3500 Contact Method: Email Adverse Event: 1 Center to which the case is being routed to: CBER Whether the case is being sent to DQRS: false Whether the report is related to drugs or food/cosmetics: 1 Whether the blood report is of type Transfusion or Collection: 2 Patient Race Code: 2f, Blood group of patient: N/A, Onset location for reaction: MedStar Location Description code for blood products: E7003, Blood group and type: N/A Blood processing type: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:&lt;5E6|2nd container Product available for evaluation: 2 Volume of transfusion: NI NHSN Workup: NI Preliminary investigation results: Developed rash &#38; stridor following transfusion prbc for anemia. Tx with benadryl &#38; epinephrine &#38; sx improved., Adverse Event Type Imputability: Blood Transfusion - Certainty: Definite; Notes: 1. notes, Eval+Plan Note, For admission to Hosp with Dx Anemia. Transfuse PRBC now., Date 20020109; 2. notes, Eval+Plan Note, Patient has developed a new maculopapular rash following transfusion. Will give Benadryl 25 mg., Date 20020109; 3. notes, Eval+Plan Note, New onset Stridor following transfusion. Will give Epinephrine .5mg, and do transfusion Rxn workup, Date 20020109; 4. notes, Eval+Plan Note, RN note - Administered Benadryl 25mg IV for skin sx. After 30 min pt. reports some improvement in skin symptoms, Date 20020109 Labs, Vitals, and Tests: 1. labs, Diastolic Blood Pressure, 75.918 mm[Hg], Date 20020109; 2. labs, Systolic Blood Pressure, 123.08 mm[Hg], Date 20020109; 3. labs, Physical findings of Skin, generalized rash, Date 20020109; 4. labs, Respiratory status finding, Stridor, Date 20020109; Illness at Time of Vaccination: 1. illness, Problem, Anemia, Date 20020109;