Age: 68.0
Sex: F
Vaccine: FLU3, FLUX, PNC13
Symptoms: Eyelid margin crusting, Eyelid oedema, Lacrimation increased, Pruritus, Skin irritation
Clinical narrative: This is a spontaneous report from a non clinical study program Pfizer for a contactable consumer and from a contactable physician. A 68-year-old female patient received PREVNAR 13, via an unspecified route of administration on 08Jan2015 at 13:00 at single dose for immunization. Medical history included High Blood Pressure and seasonal allergies. Patient had past allergy to Thiomersal in 1980 due to which she got swelling in her face and eyes. Concomitant medication included lisinopril 10mg daily since Oct2013 and ongoing for high blood pressure, VITAMIN D3 5000 qd since Oct2013 and ongoing, FLONASE 2 puffs daily since Oct2013 and ongoing for seasonal allergies, FLU VACCINE at 1 DF on 08Jan2015. The patient experienced eyes were crusty and weeping on 10Jan2015 with outcome of recovered, swelling in eye lids on 08Jan2015 with outcome of recovered, eyes were itchy on 08Jan2015 with outcome of not recovered, edges of the rim of the eye lids were red not the eye ball itself just the eye lids on 08Jan2015 with outcome of not recovered, eyes were crusty and weeping/my eyes were tearing on 10Jan2015 with outcome of recovered, redness and itching of my face-down from my eyes onto my cheeks on 10Jan2015 with outcome of not recovered. Therapeutic measures were taken as a result of the events. The consumer described the events as follows: "I tried other eye drops including equate lubricant eye drops which were soothing but did not step the reaction also refresh Liquigel which further irritated my eyelids, increased the itch and redness and swelling. The tears in my eyes further irritated my eyelids and my entire face. My face became red and irritated down from eyes onto my cheeks. Once I saw my eye doctor, he let me know that the eye ointment he prescribed might not be enough to stop the reaction. After seeing Physician, the eye doctor, I saw the P.C.P he believed I would need a course of systemic steroids. Two times in the past, steroids were ordered for me when I had bud poison IVY but, the steroid caused me to have rapid heart rate, could not sleep, terrible dreams, very hyper. So, I asked to give the eye ointment a few days to work before I would go on steroids. I have been using FML eye ointment since 20Jan2015 and 25 mg of BENADRYL to try to stop the reaction. Since 05Feb2015 it seems that the reaction is improving. My eye lids remain red-but not as red, and there is no weeping of the eyelids now but beneath my eyes-onto my cheeks, there is still redness. I am washing my face several times a day to remove any tears since it does seem that my tears irritate my face. I have an allergy to Thimerosal which I found out in the 1980's. I always ask for preservative free vaccines but I am not sure if this pneumonia vaccine was preservative free. I contacted Pharmacy where I received the flu vaccine (also 08Jan2015) but they assured me that the flu vaccine I received was preservative free. I also sent the bottle of Equate eye drops back to the manufacturer since they asked me to send it. I am hoping this is resolving, my eyes and face look some better." The reporting physician confirmed the occurrence of the events but was not sure that Pfizer product had a causal effect. Follow-up (12Feb2015): New information obtained from the same contactable consumer includes: additional events (redness and itching on my face-down from my eyes onto my cheeks), additional concomitant (FLU VACCINE), treatment, outcome and event details. Follow-up (27Feb2015): New information from a contactable physician includes: confirmation of the occurrence of the events and causality assessment.