Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Drug hypersensitivity, Dyspnoea, Echocardiogram normal, Fatigue
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (the patient). An 82-year-old female patient received PREVNAR 13 Lot/Batch Number L31687, via an unspecified route of administration in left shoulder, on 07Apr2015, at 0.5 ml single, to prevent bacterial pneumonia; NORVASC, lot number 160152, expiry date Oct2017, NDC number: 68645-444-70 tablet, from an unspecified date in 2014 and ongoing, at 5 mg 1x/day (at night), for angina pectoris and high blood pressure; unspecified blood pressure medicines (ongoing); unspecified supplements (ongoing). The physician tried her out on a lot of different blood pressure medication before starting her on amlodipine besylate. Relevant medical history included osteoporosis (due to it the patient had shrunk downwards 4 inches that was in the bone density test; she was used to be 5 feet 6 inches years back, but now she is 5 feet 2 inches), bacterial pneumonia in 1992 at the age of 59 years, low back muscle pain (years before this report in the past, the patient had therapies), high blood pressure diagnosed since middle age and ongoing, cataract surgery from Dec2013 to 11May2016, osteoporosis from 2011 to ongoing. Concomitant medications included Aspirin orally at 81 mg, 1x/day for blood thinner, Vitamin C orally at 500 mg, 1x/day, cholecalciferol (manufacturer unknown) orally at 200 IU, 1x/day for bone building, cyanocobalamin (manufacturer unknown) orally at 500 mg, 1x/day (to keep from washing out when she takes anti-reflux medicine) all from unknown date and ongoing. Previously the patient received lisinopril (manufacturer unknown) at 20 mg for blood pressure low and experienced tongue swollen on 01Jul2014 and allergic reaction on unknown date and she had to take BENADRYL to treat the reaction, two pneumococcal vaccine in 1993 at 60 years and in 1998 at 65 years; she also experienced some allergies with other blood pressure medicines (unspecified). The patient experienced arthritis pain in left shoulder, pain in shoulder, fatigue, more fatigue, soreness at the injection site and slight dizziness, and stated 'It could be crowding her lungs and stomach', on an unspecified date. The patient experienced shortness of breath on an unspecified date in Mar2016. The patient experienced double Pneumonia the week of 05Dec2016 and following, with outcome unknown. The patient underwent lab tests and procedures on 12Jan2016 which included: blood tests, cholesterol with unspecified result; Alpha-Gal allergy test performed on 12Jan2016 showed allergy to four legged animal meat and nitrates; on an unspecified date: allergic testing, laboratory test all with unspecified result. Oxygen saturation on 19Apr2016 was 97-98% and echocardiogram performed on 28Apr2016 showed that heart muscle back to normal. No therapeutic measures were taken as a result of the events slight dizziness, soreness at the injection site, fatigue, more fatigue, pain in shoulder/ soreness in her left shoulder and arthritis pain in left shoulder. Arthritis pain/shoulder arthritis in that left shoulder was reduced but not recovered. The patient did not recover from pain in shoulder and shortness of breath. The patient was still experiencing fatigue/more fatigue and slight dizziness, soreness at the injection site, shortness of breath,lost 4 inches in height from osteoporosis. The patient was not admitted to hospital due to the event. In Oct2015 the patient received annual flu shot in right shoulder without complication and Loratadine in Feb2016. Follow-up (16Feb2016): New information reported from a contactable consumer includes: start date and indication of amlodipine besylate, no treatment received for the events, outcome, clinical course. Follow-up attempts completed. No further information expected. Follow-up (01Mar2016): New information from the same contactable consumer included: outcome of the events updated. Follow-up attempts completed. No further information expected. Follow-up (11May2016): New information reported from a Pfizer-sponsored program from a contactable consumer includes: dose of PREVNAR 13, medical history, confirmation that the suspect drug was amlodipine besylate (manufacturer unknown), concomitant medications, new events (shortness of breath and body height decreased), lab data, outcome, clinical course. Follow-up (07JUL2016): Follow-up attempts are completed. No further information is expected. Follow-up (30Jan2017): New information from a contactable consumer included New event double pneumonia, product trade name. Amendment: Legacy paper report 2016031233 added as linked report number. Sender's Comments: Linked Report(s) : 2016031233 Legacy paper report number.