Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Depression, Emotional distress, Injection site bruising, Injection site mass, Injection site swelling
Clinical narrative: that the area around the lipoma had a yellowish old bruise-like color/bruise-like discoloration of the skin in the site of administration; severe swelling; her skin feels harder in that area; was allergic to one of the preservatives in the vaccine; was allergic to one of the preservatives in the vaccine; received the vaccine inappropriately in a low part of her right arm; a lipoma on her arm at the injection site of a pneumococcal 13-val conj vac (dipht crm197 protein) injection; This is a spontaneous report from a contactable Nurse (patient).  A 65-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), intramuscular on 20May2019 at single dose in a low part of her right arm for immunisation.  Medical history included ongoing mild asthma, allergies to all kinds of trees and dogs and rodents, and two kinds of dust mites, and everything but cats since 2003, a cough and scratchy throat and her eyes would get affected, sick with the sinus issues, fatigue. Historical Vaccine included flu shot. The patient's concomitant medications were not reported.  The patient had developed a lipoma on her arm at the injection site of a pneumococcal 13-val conj vac (dipht crm197 protein) injection that was also described as a severe swelling the size of half of a golf ball and her skin felt harder in that area, about 4 months ago she noticed that the area around the lipoma had a yellowish old bruise-like color. The patient had bruise-like discoloration of the skin in the site of administration as a side effect for receiving pneumococcal 13-val conj vac (dipht crm197 protein), she believed that she received the vaccine inappropriately in a low part of her right arm. Caller states that the nurse who gave it to her, gave it lower than the caller would have given it. She had several allergies, the fact that this lipoma did not go away made her depressed. Her physician told her that this might be a reaction to the preservatives of the vaccine and the patient thought there was a chance she was allergic to one of the preservatives in the vaccine. She also wanted to know if this lipoma was ever going to go away. she is so upset and very disturbed, because it makes her arm look deformed. Caller got the injection, and in about 10 days, she could see that arm, it didn't get red, it just got big like a bulge, and in 10 days she was calling her doctor, and he was seeing her again and said that it looked like a lipoma. Caller states that her doctor told her to give it a month, and so the caller went back in a month, and the caller was sent for an ultrasound and right when she took her jacket off, the doctor said that he could see right away that swelling on her right arm. Caller stated that they ultrasounded her left arm too, to be able to compare the two, and the ultrasound revealed that it was a lipoma and there was no cancer cells at the time. But caller states that what was troublesome, was that she kept hoping it would go down, and go away, but it was like harder tissue. Caller states that she was just so upset and mad at herself. Caller stated that her doctor told her that this was extremely rare, but anything that was rare, the caller got it. Caller stated that humidity affects her, and she has issues from it, but nothing major. Caller stated that she ate organic and did everything good for her heath, and if she had known this would have happened, she would not have gotten it. Caller stated that she did not take flu shots anymore. Caller states that she was not going to get the second pneumococcal 13-val conj vac (dipht crm197 protein) shot either. Caller stated that she used to take the flu shot when she was teaching, because she was around kids and was always sick with the sinus issues and strep from the kids. Caller stated that she was much healthier since she retired, cause she had been doing some sub-ing and she had tremendous side effects from going in to those buildings. Caller states that she would test it to try and figure out which buildings bothered her, and she would get a cough and scratchy throat and her eyes would get affected, and she couldn't read a story to the kids before the buses came, so she had to quit that job. Caller confirmed that she had asthma and allergies prior to ever receiving the Prevnar 13 vaccine. Caller stated that her doctors were all relieved when she decided she was done. Caller stated that her doctors said that as she got older, she shouldn't keep pushing it. And caller stated that she was totally (14Sep2020) done with it now, especially with COVID. Caller states that the doctor was going to just give her a pat on the back, and tell her that she is going to have to live with it or have surgery. Caller stated that this whole thing made her upset because she felt there was like no recourse, and she cannot get the bulge to go away. Caller had tried ice and hot packs and nothing works. The outcome of the event lipomas was not recovered, of other events was unknown at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the temporal relationship, the association between the events lipoma and bruise-like color with pneumococcal 13-valent conjugate vaccine can not be fully excluded. There is a reasonable possibility that the events severe swelling and skin feels harder were associated with pneumococcal 13-valent conjugate vaccine based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.