Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: hives that have formed all over her body including her face; Rash; Fever; This is a spontaneous report from a contactable consumer (patient's mother) or other non hcp.     A 20-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry Date: unknown, Batch/Lot number: EN0202), via an unspecified route of administration on 13Jun2021 as single dose for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EN0185), via an unspecified route of administration on 23May2021 as single dose for COVID-19 immunisation. Caller states that she took her daughter to the urgent care and was surprised that the PA that saw here didn't give her a shot of cortisone or steroid. The PA stated that the shot would take away from the effect of the vaccine. Caller wants to know if she should get a cortisone shot or not. Caller was provided the following information from the attached document: People with a weakened immune system, including people receiving medications that weaken the immune system, may have a lower response to the Pfizer-BioNTech COVID-19 Vaccine. Caller wants to know what can do with hives that have formed all over her daughter body including her face. The following information was provided from the attached document: In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. Caller wants to know that if her daughter gets a booster shot will she have the same reaction or worse? The following information was provided to the caller: The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On 25Feb, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against.  While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine.  The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Pfizer is unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the authorized information. The patient PA stated cortisone would be contraindicated with the effects of the vaccine. The caller is worried and watching the patient for her breathing in case she needs to go to the emergency room. The caller feels the rash is from the vaccine. If the patient needs another booster in the future, the caller is worried that the reaction will be worse. On 13Jun2021, the patient experienced fever and rash on 15Jun2021. It was reported that The patient had the fever the same day and day after, that Sunday and Monday. Tuesday and today, the patient has a rash all over her body- arms, face, big hives on back and legs. When the patient woke up today, the rash was on the patient's face. The patient went to an urgent care center today and was told to keep taking Benadryl and if the rash is not gone in 48 hours then to come back in, but the caller was concerned that the patient didn't get cortisone or benadryl shot. The patient has been taking Benadryl every 4 hours and it has not helped with the rash. Benadryl- lot, NDC, and expiration unknown. The rash is worse today than yesterday. The PA said giving the patient cortisone would be contraindicated with the effects of the vaccine. The caller is worried and watching the patient for her breathing in case she needs to go to the emergency room. The caller feels the rash is from the vaccine. The caller was told to report this event. It was reported there was a product complaint. The patient Therapeutic measures were taken with cortisone and Benadryl every 4 hours as a result of hives that have formed all over her body including her face, fever, rash. The outcome of event fever was recovered on 14Jun2021, for event hives that have formed all over her body including her face outcome was unknown and for event rash outcome was not recovered