Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pruritus, Urticaria
Clinical narrative: She started getting hives and scalp itches/ It started on her inner arms, this was the first place, then moved to her upper stomach; She started getting hives and scalp itches/ her head and scalp are itching; She started not feeling good after 12 hours; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 13Aug2021 13:30 (at age of 48 years old) (Lot Number: EW0164; Expiration Date: Aug2021) as single dose for covid-19 immunisation. Medical history included ongoing asthma (she had since childhood), ongoing lupus (had since birth but diagnosed in her 20's), ongoing Anti-phospholipid syndrome (had since birth but diagnosed in her 20's, this is a clotting syndrome), she had allergic reactions to medications before, she had neck surgery and couldn't look at her back but her son helped her look and spinal cord injury. The patient was a nurse, she was hurt at work and did not work at this point.  She explained that she had a spinal cord injury from work and was not current working, this was prior to the vaccine. She had to get clearance to get the vaccine because she had a kidney issue. There were no concomitant medications. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 23Jul2021 1:00 PM (at age of 48 years old) (Lot number: EW0164) administered in Right Arm as single dose for covid-19 immunisation. The patient never had a reaction to a vaccine. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. The patient stated that she got the 2nd dose on Friday, got hives yesterday (on 15Aug2021) and they have gotten worse and went to urgent care and advised to take Benadryl. It was explained that they told her they would give her Depo Medrol dose pack or prednisone but were concerned that it would affect the efficacy of the vaccine. She was told at urgent care to just try and continue to take Benadryl and that if she was not better by today or tomorrow to go see her primary care doctor. It started on her inner arms, this was the first place, then moved to her upper stomach. Also it started on her lower back and has moved up to her arm pits, up to her neck and back, and chest, even her head and scalp are itching. According to caller, she had her 2nd dose of the vaccine last 13Aug2021 at around 1:30PM EST, she started not feeling good after 12-hours and on mid morning of Sunday (14Aug2021) and she started getting hives and scalp itches (on 15Aug2021). She stated that she had allergic reactions to medications before and was usually given depo-medrol injection and prednisone, but her urgent care doctor felt that if they give her those steroids (depo-medrol and prednisone), it will reduce the efficacy of the vaccine and she will not get the full benefits, and now she's scared because her urgent care doctor stated that if she's not better after taking the Benadryl, obviously it would impair her breathing and needs to go to the ER. She was scheduled to see her Primary Care tomorrow. She has started nothing new, no new soaps or medications. She remarks she would think her air way closing would be the priority. She knows to go to the emergency room if the hives get worse. The patient was freaking out, she was scared of the virus and debated on getting the vaccine but was immunocompromised. She had to get clearance to get the vaccine because she had a kidney issue. The event hives was serious with serious criteria of Medically Significant. The outcome for hives, Itching was not recovered. Hives was reported as worsened. For not feeling good was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of hives(urticaria) cannot be excluded.But also consider relevant allergic history of asthma and other events.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.