Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Acoustic stimulation tests normal, Deafness unilateral, Ear discomfort, Ear infection, Injection site erythema
Clinical narrative: it's a warm armband rash about four fingers wide around her arm; injection site reaction as, red, swollen and warm to touch; injection site reaction as, red, swollen and warm to touch; injection site reaction as, red, swollen and warm to touch; ear infection; her arm itches; her arm was sore or whatever after which was ok so she went on and that didn't bother her; This is a spontaneous report from a contactable consumer who reported for herself, a 72-year-old female patient who received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: CD0208, expiration date: Nov2020) at 71 years of age, intramuscularly to right deltoid, right arm, she thought in her deltoid on 14Nov2019 18:30 at a single dose as prophylactic for pneumonia. Medical history included COPD diagnosed about 20 years ago and patient took no meds for that. Patient said that she has mild COPD but it was not anything to worry about. Concomitant medication was nor reported. The patient previously took influenza vaccine (FLU VACCINE) for immunization. It was reported that pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) made rash, band 1/2 way around arm 3 fingers wide. Per patient, she developed ear infection since pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine. She described injection site reaction as red, swollen and warm to touch on 21Nov2019. Stated that it was pruritic, as well. The patient had pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot a week ago yesterday, and she knew her arm was sore or whatever after which was ok so she went on and that didn't bother her in Nov2019. She then came down with an ear infection and knew it was a bacteria in there and that this was not supposed to cause one but she hasn't had one since she was a kid and she was 72. She did not know, but she could not hear out of that ear and now her arm itched in Nov2019. The right Arm band rash started last night and it was a warm armband rash about four fingers wide around her arm on 21Nov2019. It was red and warm where they gave her the shot, but it probably did not go all around her arm and was just on the outside of the arm. Patient would like to know if she needed to seek medical attention or if it would go away. She did seek medical attention for her ear. Patient looked at the rash while she was on the phone and described it as red hot and said that it itched. She did not understand this, and she did nott know if it would be considered a rash. It was about three fingers wide and was like a partial arm band that goes a third of the way round. It got worse from when she noticed it first which was why she was calling. She just noticed the rash last night when she touched her arm because she has been busy and didn't pay attention and then had the ear infection and her arm was itching and she looked at it. She didn't know it was hot until she touched it. The ear infection was on the same side as the injection was given, on the right side. She went to a walk in clinic for the ear infection and was diagnosed with the ear infection in 20Nov2019. Her ear was still blocked up and she was taking a Z-pak for it (manufactured by Lupin, NDC: 68180-160-11, Expiration date: 31Mar2021, Lot number: G902852). She took two tablets (250 mg per tablet) the first day, and was taking one a day after that for a 5 day course. Ear felt blocked, first the patient had ear infection, took Z PAK (azithromycin) ear still felt blocked went to ENT (ears, nose, and throat), hearing test normal for age but ear still feels blocked- returned 6 weeks for more testing. Patient weight on unknown date: 149lb, height: 5'4". Patient said that they did no labs and just looked in her ear. The patient said that the walk-in clinic would probably give her a steroid or something, which she doesn't want. The patient asked if she should let it go or what and also asked if this was normal because she has never seen this before and can't tell what to do. Patient said she has the pamphlet but that doesn't have anything about that in it. She did not have any of what was on there as side effects, and had a warning that if she noticed symptoms like swelling of the face or throat and having trouble breathing, but she was not having that. The outcome of "injection site reaction as, red, swollen" and "her arm was sore or whatever after which was ok so she went on and that didn't bother her" was recovered, outcome of "her arm itches" was unknown, while outcome of the rest of the events was not recovered.  Follow-up (10Dec2019): New information received from the same contactable consumer in response to Non-HCP letter sent that included: deleted concomitant drug, lab data, updated outcome, event details.  Follow-up attempts are completed. No further information is expected.