Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Injection site haematoma, Insomnia, Pruritus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 93-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Oct2021 (Lot number: FF8841) at the age of 92 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS taken for anticoagulant therapy; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BENADRYL; TYLENOL; PREDNISONE taken for rash. Vaccination history included: Bnt162b2 (Her first vaccine was on 23Jan2021, with lot number EN5318., Her first two vaccines were given in her left arm), administration date: 23Jan2021, when the patient was 91 years old, for Covid-19 immunization; Bnt162b2 (Her second vaccine was on 13Feb2021 with lot number EN5318., Her first two vaccines were given in her left arm), administration date: 13Feb2021, when the patient was 91 years old, for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "she hasn't been able to sleep at night"; PRURITUS (non-serious), outcome "not recovered", described as "body itching"; RASH (non-serious), outcome "not recovered", described as "rash all over her upper body, including her arms, back, and stomach"; INJECTION SITE HAEMATOMA (non-serious), outcome "recovered", described as "Her arm had a big hematoma where she had the shot in her right arm.". The events "body itching" and "rash all over her upper body, including her arms, back, and stomach" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient received 3 doses of the COVID shots. She doesn't had a prescribing doctor. It has been five months now, and she hadn't been able to sleep at night. She had been experiencing body itching and a rash all over her upper body, including her arms, back, and stomach. She had been to a Dermatologist 5 times, and nobody can say what it was. She had tried antihistamine, steroid ointments, and prednisone, and none of them worked for her rash. Right after her booster shot, four days later, she developed COVID arm. Her arm had a big hematoma where she had the shot in her right arm. She had recovered completely from that. Her first two vaccines were given in her left arm. The rash started about two weeks after the booster. It started with itching skin and then broke out from there. She got her first two vaccines in her senior complex. For a year and a half she had been on Eliquis a blood thinner. She takes 2.5mg in morning and 2.5mg at night. She had tried taking Zyrtec, Benadryl, and Tylenol. She doesn't know what else. She checks her medicines regularly. Patient visit dermatologist and primary Physician Office. Patient did not visit Emergency Room. Patient did not taken prior Vaccinations (within 4 weeks). Patient medical history (including any illness at time of vaccination): provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: no. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI).  Description of complaint: She has tried antihistamine, steroid ointments, and prednisone, and none of them worked for her rash. She doesn't have the NDC/lot/expiration for those products. She knows she has tried Zyrtec, Benadryl, and Tylenol, but doesn't know what else right now. Is a sample of the product available to be returned, if requested (Y/N): Yes, caller was informed of a  prepaid mailer in 3-10 business days.  No follow-up attempts are possible. No further information is expected.