Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site reaction, Pain, Rash macular
Clinical narrative: This is a spontaneous report obtained from two contactable pharmacists. A 76-year-old female patient received PREVNAR 13 (Lot M69971, Expiration date: Jul2017, NDC number: 00005197105) on 17Dec2015 at 11:46 A.M., in right arm, at 0.5 ml, single dose; and second dose of FLUVIRIN (Lot 1515101, Expiration date: May2016, NDC number: 66521011810) intramuscular, in right arm, on 17Dec2015, at 0.5 ml, single dose. The vaccines were administered at pharmacy and were purchased with private funds. No illness was noted at time of vaccination. No antipyretics were administered prior to vaccination. Relevant medical history included ongoing high blood pressure (diagnosed years before this report, prior to age 65), ongoing gout (diagnosed at least 4 years before this report), blood clots (diagnosed 4 or 5 years before this report, developed after knee and hip surgery, 3 blood clots in her lung, one blood clot in her leg), ongoing fluid retention (diagnosed prior to age 65), ongoing degenerative back pain (diagnosed prior to age 65), knee operation (done 4 or 5 years before this report), hip surgery (done 4 or 5 years before this report), pain (ongoing), neuropathy (ongoing), and osteoporosis (ongoing). The patient previously received, on an unspecified date, the first dose of FLUVIRIN and influenza vaccine (every year). Concomitant medications included ongoing furosemide, 80 mg twice a day by mouth, for fluid retention; ongoing levothyroxine 75 mcg once a day by mouth, for her thyroid; ongoing vitamin D, 5000 IU, every other week by mouth; ongoing allopurinol, 300 mg once a day by mouth, for gout prevention; ongoing oxycodone hydrochloride, paracetamol, 10-325mg, one tablet every 6 hours by mouth, for pain; ongoing KLOR-CON 20 mEq, 1 tablet twice a day by mouth, for potassium replacement; ongoing LYRICA, 150 mg twice a day by mouth, for neuropathy (for damaged nerves after surgery); ongoing carvedilol, 25 mg, one tablet twice a day by mouth, for heart rate and high blood pressure; ongoing warfarin, 2 mg once a day by mouth, as blood thinner; ongoing alendronate sodium, 70 mg weekly by mouth, for osteoporosis; and ongoing omeprazole 40 mg once a day by mouth, for stomach acid reduction. The patient experienced redness on her arm on an unspecified date, pain/pain under her arm (the pain went into her armpit) on 17Dec2015 (2 to 3 hours after vaccination), pain at injection site on 23Dec2015, and splotchy redness around injection site about the size of a softball on 23Dec2015. The redness is splotchy and not an exact circle. The patient was diagnosed with cellulitis in her arm and prescribed antibiotics. The events required an emergency room or doctor visit. No hospitalization required. The patient recovered from the events at time of this report. Patient has had the influenza vaccine every year and has not had any reactions to it, so they were assuming the events were due to the pneumococcal vaccine. Follow-up (08Feb2016): New information from the contactable pharmacist includes: reaction data (cellulitis of arm added as additional adverse event), case seriousness changed from non-serious to serious and patient's clinical course. Follow-up attempts completed. No further information expected.