Sex: M
Vaccine: COVID19
Symptoms: Erythema, Scab, Vaccination site reaction
Clinical narrative: wound type circular mark on his arm where he received the second shot; had a site reaction to his right arm with a red circle; it has not healed but scabbed about 5-6 times in the beginning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570).  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset Mar2021, outcome "not recovered", described as "wound type circular mark on his arm where he received the second shot"; ERYTHEMA (non-serious) with onset Mar2021, outcome "not recovered", described as "had a site reaction to his right arm with a red circle"; SCAB (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "it has not healed but scabbed about 5-6 times in the beginning".  Additional information: Patient husband and patient both had the Pfizer Covid shots in April. Patient husband still has a wound type circular mark on his arm where he received the second shot. it was approximately 1/2 round. Patients family dr. has directed him to go to a dermatologist but she was concerned if this is something you have seen before and if he should even get the remaining booster shot and also how should this area be treated. it is almost as if it never healed. please please advise.  Proposed response: Review EUA PI (LAB-1451-10.0 Revised: 22Sep2021) and speak from (withheld). A review of the Prescribing Information for <Pfizer Biontech covid vaccine/Comirnaty> did not find information regarding [wound type circular mark on arm where shot was given. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider. Pfizer does not provide any recommendations regarding the management or treatment of potential adverse events/reactions/symptoms that a patient /consumer may experience. Patient queried if he should even get the remaining booster shot. Patient had a side effect after the first dose of the vaccine. Should he get the second dose? Proposed responded from FAQ: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Review EUA PI (LAB-1451-10.0 Revised: 22Sep2021) and speak from (withheld). A review of the Prescribing Information for <Pfizer BioNech covid vaccine> failed to find any information regarding [receiving a booster shot after experiencing an adverse reaction at injection site]. Please consult with your doctor or health care provider for further guidance, as your doctor/healthcare provider is the most familiar with your medical condition. Additional Context: Stated that he is 68. Stated that he had two covid shots one on 01Mar and the other on 29Mar. Stated that he is due for his booster today. Stated that he had a site reaction to his right arm with a red circle for the second shot. Stated it has not healed but scabbed about 5-6 times in the beginning. Stated that it was hurting to touch. Stated that it recently started not hurting to touch. Clarified that the right arm was for the first shot and the left arm for the second shot which was fine. Wanted to know what the situation is on it. Stated that it is a 3/8 inch round red circle with a center that looked scabbed that was open for months that never fully healed and stopped scabbing. Stated that his primary doctor recommend that he see a dermatologist which he has not been able to get in until November. Stated that he just had a site reaction from the shots and had no ill reaction. Wanted to know if he should get his booster which is due today. Stated that this was reported online. Clarified there was no report completed that he only asked a question with this case number.  Follow-up attempts completed. No further information is expected.