Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Impaired work ability, Influenza virus test negative, Injection site pain, Laboratory test normal, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer, from a contactable physician and from a contactable nurse. A 69-year-old female patient received first dose of PREVNAR 13 (lot/batch number M51193, expiry date 01May2017) intramuscularly on the right deltoid at 0.5 ml, single on 17Feb2016 at 10:36. Medical history included ongoing  hypothyroidism, hyperlipidaemia, ongoing allergies and she was sensitive to vaccines (she got sick, details unknown). Concomitant medications included SYNTHROID at 50mcg daily ongoing, PROZAC at 10 mg, daily ongoing, FLONASE nasal, 1 inhalation both noses daily ongoing, PROAIR at 10 mg, 1x/day, PROZEN 10mg daily and VIVELLE-DOT 0.1 mg transdermal patch 2x week. The patient mentioned that after being vaccinated on 17Feb2016, she was ok for 4-5 days, then could not work for 2 and a half weeks. All symptoms slowly improved starting from administration of antibiotic, given 1 and a half weeks after shot. It took around 5 weeks to feel okay. Clinical course was as followed: On 17Feb2016 the patient experienced upper respiratory infection (URI), and was treated with antibiotic from 10Mar2016; on an unspecified date in Feb2016, the patient experienced sick/got really sick, the arm site was painful for about three days and she could not lay on it, immediately had pain at the injection site. Four-five days after vaccination, on an unspecified date in Feb2016, the patient experienced severe chest pain, severe cough, she was very weak, had joint pain, muscle pain, headache, nausea, fever, chills, sweating/clammy. On an unknown date she experienced extreme dizziness. The events did not require emergency room or physician visit. The patient underwent unspecified laboratory test and Flu test on unknown date and resulted negative. The doctor prescribed clarithromycin for sickness and antibiotic for nausea; she took TYLENOL for pain at the injection site. No treatment was given for arm site was painful, chest pain, cough, she was very weak, had joint pain, muscle pain and headache. She did not recover from the events joint pain, while she recovered from the other events in 2016. Dizziness lasted 2 and a half weeks and clammy until antibiotic was started. The nurse considered there was not a reasonable possibility that URI is related to PREVNAR 13. Follow-up attempts completed. No further information expected. Follow-up (21Mar2016): New information reported from a contactable physician includes: details of suspect vaccine, medical history, concomitant medications, laboratory test (unspecified), confirmation that the patient provided information to the physician regarding the reported adverse events with the use of the vaccine. Follow-up (20Jun2016): New information reported from a contactable consumer included: new event Dizziness; con meds data; events outcome; lab test; course of the events. Follow-up (11Jul2016): New information received from a contactable nurse includes: new event (URI added), causality, medical history, concomitants and event details updated. Follow-up (22SEP2016): Follow-up attempts are completed. No further information is expected.