Sex: F
Vaccine: PNC13
Symptoms: Skin reaction, Vaccination site erythema, White blood cell count increased
Clinical narrative: swollen shoulder to her elbow; slight fever; it was a little red. Like palm size redness; white count was elevated a little bit; skin reaction; This is a spontaneous report from a contactable Pharmacist. A 65-year-old female Pharmacist (patient) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, Batch/lot number: Not Provided) via an unspecified route of administration in Oct2018 at single dose for immunization. Historical vaccine included flu shot (Most of the time with the flu shot she has muscle pain) for immunization and had muscle pain. Concomitant medications were not reported. She got the Prevnar 13 shot two years ago and had a bad reaction. It was a week later she had a reaction. She experienced a swollen shoulder to her elbow on an unspecified date in 2018. She went to the doctor for the check up and was provided with two antibiotics. The doctor said that it could be an infection, but not at the injection site. She went to her doctor recently to see if she can take the COVID vaccine. She was asking if it was safe and if she was able to take the COVID vaccine. She was 65 years of age. She was a pharmacist. Caller states in Oct2018 she received Prevnar 13 shot and it was made by Pfizer. She had the shot on Monday. Most of the time with the flu shot she has muscle pain. When she got the Prevnar shot on Monday, on Tuesday she had a slight fever and it was a little red on an unspecified date in 2018. Like palm size redness on an unspecified date in 2018. She let it go because previously some other shots would have the same thing. On Friday, she had concern because her doctor wasn't going to be available, so he ordered a CBC and everything was ok. She went to the ER on Saturday because the swelling got bigger. The white count was elevated a little bit on an unspecified date in 2018. They said to wait and see. They drew the line and she went home. On Sunday, it was still there and the area was quite big. She went back to the ER. They gave her Septra DS, two BID (twice a day). She was still concerned and she called doctor. He added Keflex, 1 gram QID (four times a day). He advised her if it wasn't better to go see him on Wednesday. By Tuesday it had gone down. Her dad was sick and she rushed back to (address). With COVID she was concerned. Her doctor thinks she could have just been getting an infection and he doesn't think it is an allergy reaction. She was still concerned. Were there any documentation of issues with allergies to Prevnar 13 with COVID vaccine? Lot of people have skin reactions with Prevnar 13, she googled it and from chatting with friends and family. It depends on the degree. This kind of skin reaction was the first time for her on an unspecified date in 2018. Normally it would stay there for a couple of days. It just happened to be a Pfizer vaccine. She doesn't think there are any components that are similar to that. She wants to know if she can get the COVID vaccine. Are there any precautions she should watch for or wait? Apparently it was not an allergy to use Epipen or things like. Caller states her reaction to Prevnar 13 was two years and three months ago. She feels lots of people have skin reactions. She wants to be transferred to Medical Information. Caller declined to report. Should she wait for more safety report to come out? It was mRNA, lipid, and PEG. She doesn't have problems with Miralax. Caller was a pharmacist, retired 2 months ago, who asks should she get the vaccine? Caller reports that she was 67 yo who has a history of a skin reaction on her left arm after receiving the Prevnar 13 vaccine. She reports that this occurred 27 months ago. She reports that her doctor said it looked like an infection from the injection, she states that she "was prescribed Septra DS 2 BID (twice a day) and it got better". She was concerned about getting the covid vaccine after having that reaction but also reports that her MD doesn't think she should worry about it. She calls today for additional guidance. Outcome of events swollen shoulder to her elbow was not recovered, slight fever, it was a little red. Like palm size redness, skin reaction was recovering; while with other event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events pyrexia and vaccination site erythema was related to PREVNAR 13 use based on known drug safety profile. Based on the temporal relationship, the association between the other events with PREVNAR 13 can not be completely excluded.  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.