(1) You are the pharmacovigilance officer working for Paeon Pharma; they hold marketing authorisation for amotic 500 mg capsules, an antibiotic for the treatment of pneumonia, and HepaBVac, a vaccine for hepatitis B On Monday morning this week, routine literature searches flagged up two cases. For each one of the potential cases below, clearly indicate . Whether you would report as an adverse drug reaction, and clearly state the pharmacovigilance-based reasons for your decision Whether the case is serious or non-serious, and clearly state the reasons for your decision * If reporting, the exact date which the case must be submitted by in order to remain compliant . If not reporting, what is the correct step with regards to pharmacovigilance data maintenance Abstract 1 Case report: A fifty-year old female was admitted to hospital for a hysterectomy. Whilst there she received a dose of 1 g amotic for an infection. It was noted that she developed a rash at the injection site. When her condition subsequently improved and the hysterectomy performed, she was discharged Abstract 2 Case report: A sixty-year old hospital doctor received HepaBVac after a needle stick injury at work. It was reported that the male doctor has developed Hepatitis B despite receiving the vaccine HepaBVac The table below may help to formulate your answer Reportable Reasons for (Y/N) whether repored Not reported. Case 2 Seriou Jan senber Pharmacovigilance action

(1) You are the pharmacovigilance officer working for Paeon Pharma; they hold marketing authorisation for amotic 500 mg capsules, an antibiotic for the treatment of pneumonia, and HepaBVac, a vaccine for hepatitis B On Monday morning this week, routine literature searches flagged up two cases. For each one of the potential cases below, clearly indicate . Whether you would report as an adverse drug reaction, and clearly state the pharmacovigilance-based reasons for your decision Whether the case is serious or non-serious, and clearly state the reasons for your decision * If reporting, the exact date which the case must be submitted by in order to remain compliant . If not reporting, what is the correct step with regards to pharmacovigilance data maintenance Abstract 1 Case report: A fifty-year old female was admitted to hospital for a hysterectomy. Whilst there she received a dose of 1 g amotic for an infection. It was noted that she developed a rash at the injection site. When her condition subsequently improved and the hysterectomy performed, she was discharged Abstract 2 Case report: A sixty-year old hospital doctor received HepaBVac after a needle stick injury at work. It was reported that the male doctor has developed Hepatitis B despite receiving the vaccine HepaBVac The table below may help to formulate your answer Reportable Reasons for (Y/N) whether repored Not reported. Case 2 Seriou Jan senber Pharmacovigilance action