Age: 81.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Fatigue, General physical health deterioration, Headache, Hypersomnia, Impaired work ability
Clinical narrative: This is a spontaneous report from a contactable consumer and contactable Health Care Professional on behalf of physician. An 81-year-old male patient received a single dose of PREVNAR 13 (Lot. J67647, Expiration date: 03Mar2016) intramuscular in the arm on 04Feb2015 at 10:00 AM. Vaccines given on same date along with suspect vaccine and within 4 weeks prior to date of vaccination were none.  Medical history included pneumonia, once 30 years before this report and once recently due to which he was hospitalized on 19Feb2014; ongoing atrial fibrillation and ongoing gout diagnosed on 19Feb2014 during hospitalization for pneumonia; ongoing ankylosing spondylosis diagnosed about 2.5 years before this report. Concomitant medication included warfarin (manufacturer unknown) 5 mg tablet orally at 1 tablet once a day from 20Mar2014 and ongoing for atrial fibrillation (for heart that 'raced' sometimes), aspirin orally at 81 mg once daily from 24Mar2015 and ongoing, furosemide (manufacturer unknown) in 2014 and ongoing orally at 50 mg twice a day for fluid retention, furosemide 20 mg, 1 tablet every 12 hours, famotidine (manufacturer unknown 20 mg) orally at two tablets a day in 2014 and ongoing, MILK OF MAGNESIA orally at 1.5 tablespoons once a day in Jan2014 and ongoing, fluticasone 50 mcg spray, twice a day as needed in 2014 and ongoing, calcium 500 mg 1-2 a day in May2015 and ongoing, COLCRYS 0.6 mg once a daily 2 times in 2014 and withdrawn, and hydrocodone/acetaminophen 5.325 mg, 2 pills daily from an unknown date and ongoing. The patient previously took ULORIC (NDC number 647640677-30) in 2014 at 80 mg for about 6 or 7 months for gout and it didn't work.  He had three gout attacks after starting febuxostat and one year before this report he had stopped the drug. The patient also mentioned that he was taking PREVNAR 13 from years and it ruined his life. On 04Feb2015 by 4:00 pm, he could not only walk and talk, he was lazy, he was sick and was getting sicker, he had pain if he sitted in chair without much padding and he had to get up. On 04Feb2015, the patient also experienced headache, couldn't stand, upset stomach, aching muscles and joints (all muscles painful and all joints painful/up through his rear end hurts and he had to get up/his knees went out on him completely), neck was painful, stomach pain. He also couldn't work for fatigue and slept 13-14 hours day. He felt like a case of the flu and after taking this shot his health has gone in every portion of his body. No relevant tests were done. On an unspecified date, in Feb2015, the patient experienced fever. On 04Feb2015, he started to get some small sores in this throat; sore throat worsened and now his throat is almost constantly sore. Treatment included gargle and use some honey twice a day. Approximately 3 to 4 days a week and experience 6 to 10 hours day a fever that penetrated his body that required to take over extra 1 to 2 hydro/APAP a day. No hospitalization was required. On 04Feb2015 he was getting sick and was getting sicker, this required hospital admission on the same day. Ever since from 04Feb2015 he had to shave twice a day. About a week after 04Feb2015, he started to get some small sores; this has been getting worse and now his throat was almost constantly sore. He was told to use some honey twice a day. His muscles getting weaker since an unknown date. He did not received treatment for pain if he sits in chair without much padding has to get up can't work fatigue /sleep 13-14 hours day, stomach pain, neck is painful, couldn't stand, upset stomach. The outcome of the events laziness, pain, sickness, flu like symptoms and general physical deterioration was unknown. The outcome of the event aching muscles and joints, his knees went out on him completely, headache, pain if he sits in chair without much padding has to get up, can't work fatigue /sleep 13-14 hours day, stomach pain, neck is painful, couldn't stand, upset stomach was not recovered. The consumer wanted to know the side effects of PREVNAR 13 and any treatments for the events and he also wanted to know information to help him turn around his problems and to help the pain in his neck. Follow-up (10Jul2015): New information received from contactable consumer includes: clinical course, details on medical history and concomitant medications, events he was lazy; he was sick and was getting sicker; he had pain if he sitted in chair without much padding and he had to get up added. Follow-up (10Jul2015): New information reported from a contactable consumer includes: details of past drug history, new events (he felt like a case of the flu and after taking this shot his health was gone in every portion of his body) and their outcome. Follow-up (20Jul2015): New information received from contactable health care professional on behalf of physician includes: suspect drug and concomitant medications details, reaction data (fever and sore throat added as additional adverse events). Follow-up (30Sep2015): New information received from a contactable consumer includes: concomitant medication dates; outcome of the event; treatments; course of events.