Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Immunisation, Pain, Pruritus
Clinical narrative: It is sore/She started to feel it on her scalp and other parts of the body.; a lot of little small bumps; redness under her skin when she scratches/ left arm red from wrist halfway her arm; broke out in a rash on her right ankle; can feel under her skin like brown specks all over her hand; hand started to itch/stated that both hands started to itch that night; She had the booster dose of Pfizer-BioNTech Covid-19 vaccine on 01Dec; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 (Lot number: FJ1620, Expiration Date: 20Feb2022) at the age of 84 years as dose 3, (booster) 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Feb2021, when the patient was 83 years old, for Covid-19 Immnunization, reaction(s): "no problems"; Bnt162b2 (Dose 2), administration date: Mar2021, when the patient was 83 years old, for Covid-19 Immnunization, reaction(s): "no problems". The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021, outcome "unknown", described as "She had the booster dose of Pfizer-BioNTech Covid-19 vaccine on 01Dec"; PRURITUS (medically significant) with onset 01Dec2021, outcome "not recovered", described as "hand started to itch/stated that both hands started to itch that night"; BLISTER (medically significant), outcome "unknown", described as "a lot of little small bumps"; RASH MACULAR (medically significant) with onset 08Dec2021, outcome "not recovered", described as "can feel under her skin like brown specks all over her hand"; ERYTHEMA (medically significant), outcome "not recovered", described as "redness under her skin when she scratches/ left arm red from wrist halfway her arm"; PAIN (medically significant), outcome "not recovered", described as "It is sore/She started to feel it on her scalp and other parts of the body."; RASH (medically significant) with onset 08Dec2021, outcome "not recovered", described as "broke out in a rash on her right ankle". That night her hand started to itch and she had been itching ever since. She had scratched her hands on the inside and the outside, between her fingers, up to her wrist. Therapeutic measures were taken as a result of pruritus, blister, rash macular, erythema, pain, rash. She started using Benadryl four days ago, and with the cortisone 3-4 days after her hands started and she started feeling it in other areas, the hydrocortisone she put it on and it helped and then it would go back to itching. She has taken something over-the-counter for itching but does not know the name of it but it is not helping. She had used the whole tube and it did not stop the itch. She used cortisone ointment. She went to a walk in clinic today and they gave her a prescription of methylprednisolone 4 mg dose pack- take 6 tablets one day and then decrease 1 per day. She had been scratching, has not put anything on her scalp.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events pruritus, blister, rash macular, erythema, pain, rash and the administration of the vaccine 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.