Vaer Report Details
Age: NA
Gender: Female
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Type: Coronavirus 2019 vaccine
Manufacturer: PFIZER
Lot: unknown
- Date report was received
- 2022-03-04
- Date form completed
- Date Vaccinated
- Date of Onset
- 0
- Number of days (onset date – vaccination date)
- 0
- Adverse Event Description
-
skin reaction of erythema multiforme type (diffuse over several body areas, with the appearance of nodules with a raised edge, persistent for several weeks); this is a spontaneous report received from a contactable reporter(s) (physician). a 16 year-old female patient received bnt162b2 (comirnaty) (batch/lot number: unknown) as dose 1, single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. the following information was reported: erythema multiforme (medically significant), outcome "not recovered", described as "skin reaction of erythema multiforme type (diffuse over several body areas, with the appearance of nodules with a raised edge, persistent for several weeks)". therapeutic measures were taken as a result of erythema multiforme. clinical course included: the reaction is described as diffuse over several body areas, with the appearance of nodules with a raised edge, persistent for several weeks and still being treated with cortisone therapy without apparent improvement. although the doctor wasn't the girl's direct physician. the lot number for bnt162b2 was not provided and will be requested during follow up.; sender's comments: based on the information in the case report, a possible causal relationship between the event erythema multiforme 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
- Lab Data
-
na
- List of symptoms
-
erythema multiforme
- Patient Died?
- No
- Date Died
- NA
- Birth defect
- false
- Vaccine Administered By:
- Other
- Vaccine Purchased By:
- Unknown
- Patient visit ER?
- No
- Patient Hospitalized?
- No
- Stay in hospital
- No
- Days in hospital
- Unspecified
- Permanent disability?
- No
- Allergies:
-
na
- Current Illness
-
na