Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.- A 33-year-old female patient received BNT162b2 (COMIRNATY), on 25Aug2021 as dose 1, single (Lot number: FD8448) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 29Aug2021, outcome "recovered" (29Aug2021), described as "tested positive for Covid after vaccine"; URTICARIA (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "developed severe urticaria and itching"; INFLAMMATORY MARKER INCREASED (non-serious), outcome "unknown", described as "Inflammatory markers elevated"; C-REACTIVE PROTEIN INCREASED (non-serious), outcome "not recovered", described as "C-reactive Protein elevated". The events "developed severe urticaria and itching" required physician office visit. The patient underwent the following laboratory tests and procedures: Allergy test: (unspecified date) inflammatory markers are elevated; (unspecified date) Negative; C-reactive protein: (unspecified date) Elevated; multiple tests: (unspecified date) inflammatory markers are elevated; SARS-CoV-2 test: (29Aug2021) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical Course: Registered nurse, female, aged 34 (withheld) received the first dose of the Pfizer BioNTech COVID 19 vaccine on 25Aug2021. Around Christmas time she developed severe urticaria and itching. Caller also reported to RA, she tested positive for Covid after vaccine and had some lab level elevations. The itching has been persistent since then. She has been to twelve providers and no doctor knows what it is. She is desperate at this point. She has tried homeopathic stuff, she has been allergy tested and she is negative for everything. She's done elimination diets, several rounds of steroids both oral and topical but nothing helps. Has this delayed onset persistent urticaria been reported? How is this treated? If someone got a shot yesterday was itching, or started itching on day 2 after the vaccine and its been lasting for 6 months what would Pfizer recommend? Caller is calling about Pfizer COVID 19 vaccine, and reports urticaria. Calling about the Pfizer COVID 19 vaccine, adult. Confirms that she is experiencing urticaria. Caller asks has this been reported by other people? She only had one dose of the COVID vaccine, and 3 days later tested positive for the COVID virus. Stated she had Regeneron treatment for COVID virus, and was told she could not have a second dose of the COVID vaccine for 90 days. She confirms she did not get a second dose of COVID vaccine. She was going to get a second dose, but she started itching. States the itching also occurred after the Regeneron treatment. She thinks it started after Christmas 2021 or around 06Jan2022. Seriousness: answers as no. Outcome: states it persisted and worsened. Had one dose of the COVID vaccine, and 3 days later tested positive for the COVID virus: Seriousness: not provided. Investigations: States she had multiple labs done. C-reactive protein remains elevated. Has gone to 13 different providers to find out what is going on with her skin. She has had multiple tests, allergy tests, and it is showing her inflammatory markers are elevated. She doesn't know what else can be causing these issues. Asks is there something she can take to stop the itching? History of all previous immunization with the Pfizer vaccine was not considered as suspect. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. No Emergency Room visit. No prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.