Adverse Drug Reaction Reporting

Consider each of the following suspected case scenarios. Should a yellow card be completed?

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Scenarios
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Answer
1 / Patient on lisinopril and develops tongue swelling. / Y (serious)
2 / A 11 year old patient receives a routine BCG vaccination and develops redness and swelling of the injection site / Y (paediatric, vaccine)
3 / Patient starts on Apixaban and is found to be hypotensive seven days later. / Y (▼)
4 / 78-year-old male patient in a urology ward has a transurethral catheter inserted post-op and is started on ciprofloxacin 500mg bd orally. Two days later penile necrosis is observed and the catheter is removed. / N- adverse event, not an ADR
5 / A 30 year old female patient develops a rash after receiving two doses of amoxicillin / N (not serious or ▼)
6 / Patient admitted to hospital with confusion and a fall. She is on bendroflumethiazide, temazepam, and paracetamol. Investigations identify hypokalaemia & hyponatraemia. / Y (serious & hospitalisation)
7 / 65-year-old female patient develops severe sunburn after spending time in the garden. She is taking doxycycline. / Y (serious)
8 / A mother took paroxetine all through pregnancy and baby born at 38 weeks with no problems. Mother continued to breastfeed while on paroxetine until child 6 months old. Two days after breastfeeding discontinued the child became agitated, fed poorly and cried more than normal. / Y (serious neonatal withdrawal syndrome)
9 / Patient on warfarin and starts taking an herbal preparation containing glucosamine and chondroitin. One week later the patients INR increases to 5. / Y (serious, herbal & interaction)
10 / 38-year-old female receiving paclitaxel for breast cancer. Fourteen days after receiving the treatment she is hospitalised with neutrophils of 0.01 (normal 2-7.5), temp 40 degrees Celsius and rigors. She is started on IV antibiotics. / Y (serious & hospitalised)
11 / Patient bought a Chinese herb from a herbalist 2 weeks ago. She is admitted to hospital today with renal failure. / Y (serious & herbal)
12 / Patient complains of a dry mouth and blurred vision after starting buscopan (hyoscine butylbromide). / No (not ▼ or serious)