Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Rash, Rash pruritic
Clinical narrative: Arm has complete rash of bumps all along shot area to the elbow; small papular rash over rt arm was itchy and red to start; small papular rash over rt arm was itchy and red to start; Arm has complete rash of bumps all along shot area to the elbow; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported for a 09-year-old female patient that:  Serious: (NO)     Seriousness criteria-Results in death: (NO)     Seriousness criteria-Life threatening: (NO)     Seriousness criteria-Caused/prolonged hospitalization: (NO)     Seriousness criteria-Disabling/Incapacitating: (NO)      Seriousness criteria-Congenital anomaly/birth defect: (NO)    Age at Vaccination: 10 Years   report about covid vaccine: Yes reporting type: AE reporter type: Non-healthcare Professional reporting for a patient relation with patient: Parent current age: 10 years gender: Female is pregnant: No race: Withheld ethnicity: Withheld  dose received 1 most recent dose details product: COVID 19, brand:Pfizer, brand unknown: False, lot number: FK5127, lot unknown: False, administration date: 09Nov2021, administration time: 02:30 PM, dose number: 1, vaccine location: Right arm  other vaccine same date details other vaccine same date product: Pfizer, other vaccine same date lot number: FK, other vaccine same date vaccine date: 09Nov2021, other vaccine same date dose number: 512, other vaccine same date  vaccine location: Right arm   facility type vaccine: Public Health Clinic facility name : withheld facility address street : withheld facility city : withheld facility state : withheld    if other vaccine in fourweeks: No other medications in twoweeks: NA  adverse event: Arm has complete rash of bumps all along shot area to the elbow adverse event start date: 12Nov2021 ae resulted in: None of the above if patient recovered: Not recovered if treatment ae: No  if covid prior vaccination: No if covid tested post vaccination: No  known allergies: Unaware other medical history: NA  Follow-up attempts are completed. No further information is expected.   Follow-up (13Dec2021): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP letter sent which included that:   Updated information included: Reporter Information, Name, Address, Occupation, Phone, Email, Fax, New event small papular rash over rt arm was itchy and red to start added. Suspect product details. Vaccine info updated.   Additional Information: Did the patient provided information to you regarding the adverse event(s) with the use of the patient: Yes  If yes above, do you consider the Pfizer product had a casual effect to the adverse event: Yes   Vaccination facility type: Doctor office/Urgent care Patient initial: (withheld) Age at vaccination: 9 Years old (Years)  Pfizer/Biontech Covie-19 Vaccine details: Dose: 1 Date: 09Nov2021 Time: 14:34 hr Anatomical site of injection: R arm Route of administration: Intramuscular Batch/lot number: FK5127  Adverse event: AE terms: Rash Onset date: 12Nov2021 Serious criteria: Not serious AE requires to visit: Physician Office AE outcome: Recovering Treatment: Yes Details: Zyrtec Benadryl  Comments/Narrative: Pt received Covid-19 first shot- on 9Nov2021 and noticed rash on Right arm 2 days later family noticed small papular rash over Right arm was itchy and red to start. Symptoms get better into Benadryl but rash stayed for few days. She was seen in clinic on 15Nov2021. Treated symptoms noticed. No shortness of breath, no chest pain and no other symptoms reported by patient.   Follow-up (13Dec2021): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included:  Additional information:   Query: Can you check this source there is a stamp date of 22Nov also? Please clarify.  Response: That stamp is not ours, the source came with that stamp on it. The person who stamped it, initialed it, it is also the same person who made the corrections on the first page.  Follow-up (22Dec2021): Follow-up attempts are completed. No further information is expected.  Follow-up (17Jan2022): This is a spontaneous follow-up report received from a contactable nurse. This nurse reported for a patient that:  Updated information included: Reporter information (Reporter slider #04), Dose Description   Additional information: Submitted by Call Centre 1 Ref: # Selected Report Type: Follow-up Is report related to a study or programme? No Is the patient also the reporter? No Reporter type: Other Health Professional Specify Other Health Professional: Nurse Primary / Prescribing Healthcare Professional Info HCP postal address:  Dates for No new adverse event: (From: Unspecified To: Unspecified)  Is BioNTech Covid Vaccine a Pfizer product? Yes BioNTech Covid Vaccine manufacturer: Unspecified Dates for BioNTech Covid Vaccine: (Start: Unspecified Stop: Unspecified) NDC number of BioNTech Covid Vaccine: Unknown UPC number of BioNTech Covid Vaccine: Unknown Reason for no lot number: of BioNTech Covid Vaccine: Caller unwilling to complete the report Expiry Date of BioNTech Covid Vaccine: Unknown  Additional Context: When probed for the concern, reporter stated, "I am actually a Nurse (hence reporter type captured as Nurse in the tab) calling on behalf of one of our patient who had an adverse reaction and we had filled out some paper work back in November or December about this and the Doctor just got the same packet of information again and she is wondering if she needs to complete it again she is not sure why she would need to complete it again since she already had done that. I can give you the Manufacture report number if that helpful."  Manufacture report number: # (Hence report captured as follow up report in the tab) Nurse stated, "This was about the Pfizer COVID Vaccine the BioNTech." (Hence suspect product name captured as BioNTech Covid Vaccine in the tab) Nurse was informed to fill the questioners and send it back to Pfizer or if they are not willing she can inform Pfizer for the same. In response to file safety report again, Nurse stated, "I don't think you need to file anything right now. We will go ahead and send them back letting them know we already completed this but if there is any additional questions we are happy to answer them." As Nurse was not willing to proceed the call. Hence further probing could not be done. Limited information available over the call.  Follow-up attempts are completed. No further information is expected.  Follow-up (26Jan2022): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP letter sent which included that:   Updated information included:  Reporter slider updated, vaccine facility information updated, Concomitant therapy updated.  Additional Information: Did the patient provided information to you regarding the adverse event(s) with the use of the patient: Yes If yes above, do you consider the Pfizer product had a casual effect to the adverse event: Yes; Most likely Are you willing to be contacted again by Pfizer on the reported adverse event(s): No  Age at vaccination: 9 (Years)  Prior vaccination: None Concomitant Drugs: None  Patient medical history: None Relevant Tests: None Specific relevant test: None  Comments/Narrative: Pr developed rash Right arm 2 days later after  receiving first dose of Pfizer Covid vacinations on 09Nov2021 It was seen in clinic, was prescribed anti-histamins (Zyrtec) and hydrocortisone (2:5%) Ointment for applications. Pt. no-showed for second Covid Shot appointinent.  Follow-up attempts are completed. No further information is expected.