Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This is a spontaneous report from a contactable physician (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in left arm on 17Feb2021 at 09:00 (Batch/Lot Number: EL9266) (at the age of 81-years-old) as dose 1, single for COVID-19 immunisation. The patient got the vaccine so she can go out and not get sick, since she is over 65. Vaccination facility type was hospital and vaccine was not administered at military facility. No other vaccines were administered on same date with the Pfizer vaccine. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had no adverse events following prior vaccinations. Medical history included anaphylaxis to shellfish, anaphylactic reaction to CAT scan dye, and ongoing osteoporosis or osteopenia with onset date: 72 years. She developed an anaphylactic reaction to shellfish in her 20s and an anaphylactic reaction to CAT scan dye in her 50s, with the CAT scan dye causing hives and itching. The patient has no family medical history relevant to adverse event. Concomitant medications included vitamin D3 2000 units daily for osteoporosis from an unspecified start date and ongoing; and acetylsalicylic acid (ASA) 81 mg taken for an unspecified indication from an unspecified start date and ongoing.  The patient experienced itching on 18Feb2021 at 01:00. Course of event was as follows: The patient was a retired physician who would like to know if the chances of having an anaphylactic reaction to the second dose of the Pfizer BioNTech COVID-19 vaccine are higher or lower. She received her first dose of the vaccine on 17Feb2021. She got her shot and waited 30 minutes before she left and was fine all that day. At 1am on 18Feb2021, she woke up itching. Patient stated it wasn't severe, just enough to wake her up, and it only lasted for about an hour. The event did not require a visit to an Emergency Room or physician office. The patient has no relevant diagnostic and confirmatory test results for the event. The event required the initiation of Prednisone 40mg slot dose once. She thought she might take some prednisone before getting the 2nd dose. She stated that she is 81, so her immune system may not be as active. She was planning on taking 100mg of Prednisone before receiving her second shot. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular administered in right arm on 10Mar2021 (Batch/Lot number: EN6205) (at the age of 81-years-old) as dose 2, single for COVID-19 immunisation. Vaccination facility type was hospital. The outcome of the event was recovered on 18Feb2021 at 02:00. The patient did not consider the Pfizer product had a causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event itching with BNT162b2 can not be fully 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.