Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: 1st dose developed a red, raised, itchy rash on RUQ of abdomen/ after 2nd dose aggravates; 1st dose developed a red, raised, itchy rash on RUQ of abdomen/ after 2nd dose aggravates; 1st dose developed a red, raised, itchy rash on RUQ of abdomen/ after 2nd dose aggravates; 1st dose developed a red, raised, itchy rash on RUQ of abdomen/ after 2nd dose aggravates; This is a spontaneous report from a contactable other health care professional (Nurse- patient herself), report received from a Pfizer-sponsored program. A 71-year-old female (non-pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3249, Expiration date and NDC number: Unknown), via an unspecified route of administration in left arm on 29Jan2021 at 11:15 (at the age 70-year-old) for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6202, Expiration date and NDC number: Unknown), via an unspecified route of administration in left arm on 26Feb2021 at 11:15 (at the age 71-year-old) for COVID-19 immunisation. Medical history included diabetes possibly diagnosed in 1998 and ongoing, obesity from an unspecified date and ongoing, anemia diagnosed about probably in the past 5-6 years and ongoing, allergies diagnosed around 2000 and ongoing, sleep apnea diagnosed around 2000 and ongoing, and reaction to the small pox vaccine when patient was a small child. The patient had anaphylaxis to cephalosporin, Keflex and rocuronium and allergic to food. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021 20:00, the patient developed a red, raised, itchy rash on RUQ of abdomen. By time of 2nd dose of vaccine, rash was still present but seemed to be fading. Approximately 4-5 days after the 2nd dose a red, raised, itchy rash developed on chest, upper abdomen, across lower back, up the middle of back and on buttocks and upper outer thighs. The patient reported that no investigations were done. The treatment received for the events were Benadryl, Zyrtec, and OTC cortisone creams and over the next 30 days rash did not improve, and medical treatment was sought. The patient tried triamcinolone (KENALOG) cream, pepcid twice a day, for two weeks and the rash was still spreading down her abdomen and up her back, so patient started on prednisone, 20 mg for 7 days and 10 mg 7 days, along with pepcid, zyrtec and benadryl, rash is still profuse. The patient was also treated with xzyal. The event was reported as serious (medically significant). Outcome of the events was reported as not recovered; Sender's Comments: Based on temporal relation, the association between BNT162B2 and the events, erythematous, papular, pruritic rash cannot be excluded.The impact of this report on 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, Ethic committees, and Investigators, as appropriate.