Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Physical examination, Rash, Sinusitis, Urticaria
Clinical narrative: sinus infection; very uncomfortable; delayed reaction after 38-42 hours or after 48 hours; rash and hives all over her body, not only on the injection site/all over her torso, legs, thighs and looks like hives; rash and hives all over her body, not only on the injection site/all over her torso, legs, thighs and looks like hives; This is a spontaneous report from a contactable nurse (patient herself) via medical information team. A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 intramuscular, administered in left deltoid at age 35 years on 23Mar2021 16:30 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunization (prevention). Medical history included none. Family history of sister that had COVID and then got vaccine. She did not get a rash but is prone to allergies and things like that. Her sister has very sensitive skin and she does get rashes. Her sister got really sick but did not have the things she had. Her sister had COVID pretty bad for a week or 2. Once her sister was COVID negative, she got the first COVID vaccine and did ok. her sister got the second vaccine and got pretty sick like she had COVID again. Patient did not ever get COVID though. There were no concomitant medications.  No vaccines administered on same date of the Pfizer suspect and no vaccines administered within 4 weeks. Patient historically took first dose of Pfizer COVID vaccine given on 28Feb2021 at age 35 years, Injected intramuscularly in left deltoid, Lot number: EN6205, expiration date unknown and just had a sore arm after injection, mild discomfort in arm. Patient would like to report an adverse reaction that may be related. Patient got the second vaccine on 23Mar2021 16:30 (Tuesday), and on Thursday afternoon (25Mar2021), she broke out in a rash like hives, pretty much all over her body. Rash and hives all over body was reported as worsened. There was no prescriber for vaccine. She just received it as a part of an initiative. This is a delayed reaction after 38-42 hours or after 48 hours. It was not near the vaccination site. It is all over her torso, legs, thighs and looks like hives. She said "hives in general if in an immuno response to BENADRYL or steroid cream". Patient stated event was medically significant. It is very uncomfortable. She doesn't normally get rashes and this was a new experience for her. Patient had labs done on an unspecified date for a physical and they were all within normal limits, such as her CBC, and CMP. She even got a C-Reactive protein and it was within normal limits. She has not left the house and has not changed detergents and has not done anything different that would cause this reaction. She wanted to know if there have been other delayed reactions like this.  She also mentioned taking amoxicillin antibiotics (Lot SM8720051-A, Expiration Mar2022. Dose was 875/125 1 tablet by mouth twice daily) for a sinus infection on unspecified date, and was on the last day and does not know if it would be clinically significant. Outcome of the events 'rash and hives all over her body, not only on the injection site/all over her torso, legs, thighs and looks like hives' and 'delayed reaction after 38-42 hours or after 48 hours' was not recovered, for the other events, it was unknown. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Rash and hives all over body, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Reporter seriousness for Rash and hives all over body: Medically significant.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes available.  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.