Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Skin lesion, Vaccination site scab
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient. A 95-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 95 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, MANUFCATURER UNKNOWN), for COVID-19 Immunization, reaction(s): "red mark the size of a dime on her arm.". The following information was reported: SKIN LESION (non-serious) with onset 2021, outcome "not recovered", described as "The scab is of a light brown-orange color and it looks like a cold sore lesion\looks like a herpes lesion"; ORAL HERPES (non-serious) with onset 2021, outcome "unknown", described as "looks like a cold sore"; VACCINATION SITE SCAB (non-serious) with onset 2021, outcome "not recovered", described as "she developed a scab the size of a dime in her injection site". The event "she developed a scab the size of a dime in her injection site" required physician office visit. Therapeutic measures were taken as a result of vaccination site scab, skin lesion.  Additional information: Caller was a 95-year-old retired Nurse calling on behalf of herself. She received the second dose of the Pfizer COVID-19 Vaccine on 16Mar2021. Since then, she developed a scab the size of a dime in her injection site. The scab is of a light brown-orange color and it looks like a cold sore lesion. Caller explained that she has tried local treatments for it, but the scab comes back every 24 hours or so. She stated that her doctor suggested a biopsy of it and she is currently consulting this case. Caller wanted to know if this side effect has been reported before. Could not find specific information on this symptom. The most similar reported side effects are injection site pain or injection site redness. These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Responded as per attached  (Off-Label or No Info) ". A review of the Prescribing Information for Pfizer- COVID-19 Vaccine did not find information regarding the side effect that you described. 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 about what you have experienced/are experiencing. States that she has a question. She got the first Covid shot and had no problems, just a red mark the size of a dime on her arm. States that she got the second dose 6 weeks later on 16Mar and had no problems. States that then she got a scab on that site. She called the doctor and the health department, they did not think anything of it. She saw the doctor 6 months later and he didn't think anything about it. Then a couple of months ago he told her she should have it biopsied. Caller states that she has put everything on it. States that it looks like a herpes lesion, a cold sore, about the size of a dime. Caller declines to complete safety report. States that she did nothing. States that here it is a year and a half later and she is getting curious about the whole thing. The doctor said to have it biopsied. Caller states she puts Neosporin on it and the scab will go away. The scab comes back the next day, she has put all kinds of creams and everything. She just wants to know if anyone else has reported this. Caller states that is is about a year and a half later and its still a scab, like a light orange scab. States she guesses she can go to the dermatologist for biopsy. States it looks like a cold sore.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.