Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: red, itchy rash at injection site; Red rash; red, itchy rash at injection site; Swollen size of a half dollar around the injection area; red, itchy rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 301308A and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 15Sep2021 at 10:00 AM (age at vaccination: 53 years), as a single dose for COVID-19 immunization. The patient's medical history included surgery (surgery for brain aneurysm) in Jun2020. The patient did not have family medical history relevant to adverse event. Concomitant medication included acetylsalicylic acid (ASPIRIN). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FA7485 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 25Aug2021 at 16:00 PM (age at vaccination: 53 years), as a single dose for COVID-19 immunization. The patient reported that on an unspecified date, she experienced red, itchy rash at injection site. The patient was treating the rash with Benadryl and ice packs. She will go see my Primary Care Provider if it gets worse or didn't go away. On 15Sep2021, it was itchy when she was given the shot on Wednesday. Wednesday evening, she had a mild itch but no rash. The patient also reported that where the vaccine was administered, there was a red rash on 16Sep2021, and it was very itchy. Yesterday morning, at the time she got up, it was a little swollen. She figured it was because that happened with the first shot but, she did not get any rash the first time. Thursday morning, it was about the size of a half dollar around the injection area and it was itching terribly. She used Benadryl and a cold pack that seemed to help a little. The patient asked how long should she just keep treating this like it is not a big deal. When does it become a big deal and she was currently fine. It was slightly swollen and with the swelling, there was the red rash, in the area where she got the vaccine, exactly. It was right around the center, where she got the vaccine, in the right arm. It was up near the top of the shoulder. The rash was the same. The itching was a little more intense, just in the areas of redness. The patient was treated with liquid children's Benadryl. She is pretty sensitive to Benadryl, so she used the Children's 5mg liquid Benadryl. It did help her somewhat. The adverse events did not require a visit to emergency room or physician office. The patient did not receive any vaccine within 4 weeks prior vaccinations. There was a Product Complaint and description of complaint was while caller was reporting an itchy rash experienced after the Covid-19 vaccine, she mentioned that she has been taking Children's Benadryl because she was sensitive to adult Benadryl. Product strength and count size dispensed: unknown NDC, LOT, EXP for adult Benadryl: Unknown, she does not take regular Benadryl because she is sensitive to it. There was no report related to a study or programme. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101236589 same reporter/patient/product, different dose/event.