Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Urine analysis abnormal, Vaginal infection, Vaginitis gardnerella, X-ray of pelvis and hip abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer and a contactable physician. A 76-year-old female patient received the first dose of PREVNAR 13 (lot 174251, Exp. date 31Oct2016), intramuscular at 0.5 ml single on left arm on 26May2015 at 11:04 am. Medical history included ongoing rheumatoid arthritis from 1978, ongoing left foot wound from 16Jan2015. On 16Jan2015, she had a callus trimmed from her left foot and she was cut. This cut became infected and she was put on antibiotics and it cleared up. The wound opened up, she was given another round of antibiotics and it cleared up again. She went to a wound clinic and the doctor didn't feel that it had healed and he opened up the wound again. She wasn't given any more antibiotic. She was bandaged and was in a boot to keep her weight off her foot. She will be going back to the wound clinic on 09Jul2015. Past drug history included ENBREL for rheumatoid arthritis, but when she had the infection on her left foot, the rheumatologist took her off this medication and since the patient has been fine and no flare ups, she was told that she can stay off this medication. Concomitant medication included CELEBREX 200 mg 2 tabs/day and 400 mg/day in 2013 and ongoing for arthritis and prednisone for 22 years: her usual dose was 3 mg a day, which was stopped on 06Jul2015 as she received "a megadose of prednisone" at 40 mg a day orally for 4 days. She will return to regular dose after the megadose. In 1994 she started prednisone 4mg and it is ongoing. On 24May, she went to see her family doctor, she came me a physical visit and everything was fine. The MD also suggested she got a PREVNAR 13 shot, and she agreed. On 30May2015 the patient experienced abdominal pain, bloating, left groin pain and gas, vaginitis, osteoarthritis in left hip; back and flank pain, and constipation. On unknown date, CT abdominal/pelvis showed constipation. The events bloating and gas required admission to hospital; no hospital admission was required for the other events. The events were described as follows: the area where the patient received the vaccine was fine. She explained pain in stomach as gas in stomach and feeling bloated. Abdominal pain, gas, bloating and left groin pain worse with sleeping and pain was severe a 10 on a 1-10 pain scale. Due to abdominal pain, gas, bloating and left groin pain patient required doctor visit: at visit on 03Jun2015 she was diagnosed vaginitis (Gardnerella like bacilli) and she was treated with metronidazole suppositories for five days and at visit on 27Jun2015 some bacteria was found in urinalysis and urine culture and she was put on FLAGYL for five days; she also went to rheumatologist on 02July2015 who gave her 2 prednisone injections in her back, not in the sciatic area but a little above it. This helped for about 2 days. Her rheumatologist thought the problem was more in the soft tissue and not a rheumatoid arthritis flare up. The patient underwent lab tests which showed: urinalysis on 03Jun2015 revealed vaginitis (Gardnerella like bacilli). On 27Jun2015 urinalysis and urine culture were done and showed some bacteria; follow up urinalysis on 04Jul2015 was clear. X-rays of pelvis and hips on 08Jun2015 showed some osteoarthritis in left hip, and patient said she knew she already had arthritis in her hips. Her doctor didn't know if the left groin pain was due to this osteoarthritis. CAT scan of pelvis done on 18Jun2015 was clear. She further stated she had CT scan, hip x-ray, sonogram: all normal. She continued with the abdominal pain and bloating, not so much of the gas anymore. Her left groin has improved but it has traveled to both sides of her back and flanks. The patient received treatment for the events left groin pain (TYLENOL), vaginitis (antibiotic from 03Jun2015 and withdrawn), back and flank pain (cortisone shots in flank), osteoarthritis in left hip (cortisone in joint), constipation (laxative), unknown for abdominal pain. Received cortisone shot in hip (sonogram guided) no help. Shots of cortisone in flank helped some. She was still bloated, groin pain severe at night, daytime mostly lower abdomen pain and back pain. The final outcome vaginitis was recovered and for all other events was not recovered. The patient stated her reason for thinking that PREVNAR 13 caused her problems because she had gone to her rheumatologist and he/she said her RA was under control. She was feeling fine. This was in beginning of May. She went to rheumatologist, gynecologist, gastroenterologist, internist, orthopedic surgeon (hip), and will see back pain specialist on 21Sep2015. The patient said that doctors didn't know if what she was experiencing was due to the vaccine or not. Follow-up (14Aug2015): New information obtained from a contactable physician includes: Exp date, unit dose, route of administration, time for PREVNAR 13; onset and outcome for the events (Abdominal pain, Back and flank pain), additional lab tests and event (constipation). Follow up (21Sep2015): New information obtained from  contactable consumer includes: seriousness criteria (hospital admission); concomitant medication CELEBREX added; conmed data updated; events onset date; outcome for left groin pain and constipation; treatments; lab tests; course of events; patient assessment.