Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Nasal congestion, Rash, Vaccination site erythema
Clinical narrative: Rash/ like a big, circular, and big rash; allergic reaction; big redness not rash, redness randomly popped up in her body/a red, red round thing underneath her forearm, left and right arm; got the vaccine on her left arm and then she is also having redness up to her second arm; breathing a little bit congested; This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180; Expiration/Date: 31Oct2021) DOSE 1 via an unspecified route of administration in the left arm on 10Aug2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Aug2021, the patient experienced, rash/ big, circular, and big rash; big redness not rash, redness randomly popped up in her body/a red, red round thing underneath her forearm, left and right arm; got the vaccine on her left arm and then she is also having redness up to her second arm; allergic reaction; and breathing a little bit congested. The pharmacist stated, "I am calling because I have your patient that got the vaccine last Tuesday (10Aug2021) and she is having a reaction. Patient got the vaccine on Tuesday and she got the rash. She noticed the rash yesterday. It's big, circular, and then big rash that appeared on her, big redness not rash I should say but redness that randomly popped up in her body. So she had a red, red round thing underneath her forearm and I guess she got the vaccine on her left and then it also I guess it's on the left but somehow it also went to the right side. She got the vaccine on her left arm and then she is also having redness up to her second arm and she said prior to that it also shows up in her other parts of the body.  It's the redness that she had been experiencing. She had been taking Benadryl and she was fine and then she went to urgent care too.  The urgent care provider told her for the second dose it's not recommended, for the second dose now that the patient has the reaction. It's considered an allergic reaction. It's the rash and she ended up getting redness that randomly popped up in her body. She was confused because according to her some people said to get it but I told her that the standard protocol is if patient is suffering the reaction, then it's not recommended to get the second dose". For treatment, the pharmacist stated, "She took a Benadryl and it's already kind of ok right now. All the rashes, it's still on there. I asked her how is her breathing and she said it's fine but it's a little bit congested so I told her to really monitor that one and the urgent care did not give her any EpiPen just the Benadryl". The patient had not recovered from the event, rash. The outcome of the other events was unknown.   No further information could be probed as there was no response from the pharmacist and the call was disconnected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events rash, erythema, hypersensitivity, vaccination site erythema and suspect drug BNT162B2 cannot be 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.