Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Oral discomfort, Paraesthesia oral, Pruritus, Rash
Clinical narrative: I started to feel a deep tingling and burning sensation on my upper lip; Entire body is in hives/it is hives all over her body; she really wants to itch herself and she is trying not to/ lot of itching; her body feels like she has chicken pox; rash/On her legs it's like patches.; lips still burning; This is a spontaneous report received from a contactable other healthcare professional (Dental receptionist reported for self). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179), first dose via an unspecified route of administration, administered in left arm on 04May2021 at 18:00 (at the age of 31-year-old), as a single for COVID-19 immunisation administered at other facility. Medical history included asthma, two mini strokes (it's been 2 or 3 years, she does not have that information), chicken pox, Patient stated she is allergic to all to medications. Her doctor does not prescribed medications to her at all. This included acetaminophen, ibuprofen, aspirin and all NSAID medications. There were no concomitant medications. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. It was reported that, on 04May2021, patient went to (withheld) to get her first dose of the Pfizer vaccine. Patient's vaccination was scheduled for 04May2021 at 18:00. Patient's allergist recommended that she wait another 15 minutes just to be sure. She had nothing in her bloodstream when she arrived because she was allergic to all over-the-counter drugs, including acetmetaphine, ibuprofen, naproxen, aspirin, and other NSAIDs. Since she had asthma and wanted to make sure this vaccine was right for her, she saw both her PCP and an allergist specialist before getting the vaccine. Suggested to her that it would be useful to her. The shot was administered to her on her left arm, on 04May2021, and shortly after receiving the vaccine on 04May2021 at 18:15, she started to feel a deep tingling and burning sensation on her upper lip, which spread progressively across the bottom of her lower lip. She told the on-duty nurse. She said it had nothing to do with the vaccine. She then led her to the seating room, instructing another nurse present to keep an eye on patient, for the first. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the event tingling lips and burning sensation. She stated she also called in to Pfizer the same day after sending it online because she missed that it said it would be taking like a week. She did this on the 22May2021. She was at her general doctor's office so she can give him an understanding of what happened. She has only taken her first dose and she was not comfortable taking her second dose after this reaction. Patient said she was not sure if all of that information was shared on her previous report. Verified that patient was referring to the Pfizer Covid-19 vaccine. She wanted to know if there was a way, she can get a call back, because the doctor may be coming in soon and she may have to disconnect the phone call. She gave a brief summary as to what she did. She did not know what she was supposed to do. She was calling to see when the follow-up was and what was her next step. She stated her body feels like she has chicken pox. She has already had chicken pox before so it's just like her entire body was in hives. She cannot wear jeans anymore, because if she wears anything tight fitting, her body goes into hives. Constant hive mode. She was sitting in her doctor's office and she really wants to itch herself and she was trying not to. At night it was ten times worse. She wanted information, but she really wants to report want her incident was. She has never been in this situation before. Her allergist even wrote out a prescription saying that nothing would happen to her. So, she needs to do a follow up with him. It has been a month in her system. She knew it was going to take like 3 weeks for the vaccine to run its course, so she gave it time. She took the vaccine on 04May2021 and it is now 06Jun2021. So, it has been a month in her system, and it was still not going away. She wants to know if there is a way, she can reverse this. She wants to know if she should go and take Moderna. Should she take Johnson and Johnson. She did not know what to do at this point. She definitely wants the vaccine in her body, but she did not want to be allergic to it. She would like a call back on Tuesday if possible. She does not have the lot number for the vaccine with her to provide. She had it on the paper and she did that online. She does not have NDC or expiration with her right now either. The rash happened right away on 04May2021. There was a lot of itching and her lips are still burning. The itching was everywhere, not just one place. It feels like she was not quite sure, if it's shingles or chicken pox. It is constantly itching. She has taken Benadryl, Zyrtec and Allegra and they have all stopped working. Nothing was working. Patient does not have medications with her at time of call and cannot provide, NDC, Lot and Expiry. She tried them a week apart, for like a week each because it has been 3 weeks. Benadryl worked for 3 days and then it stopped. Then she tried Zyrtec, which worked for a day and then nothing. It worked for like a couple hours. Allegra worked for maybe 3 hours and then it stopped. If she wears tight jeans and a t-shirt on top and then if she takes them off a couple hours later, it was hives all over her body. On her legs it's like patches. She does not know how to stop this itching. Since the issue started, it was the same. there was no improvement. Normally when she was allergic to medications, she takes Benadryl because that helps her soothe it down and within a day it was gone out of her system, but now that the vaccine was in her system and none of these medications are working. She did not know what to do. It was reported that there is a product complaint to report. She was at her general doctor's office so she can give him an understanding of what happened. She has only taken her first dose and she is not comfortable taking her second dose. Complaint regarding Benadryl, Zyrtec, and Allegra: It is constantly itching. She has taken Benadryl, Zyrtec and Allegra and they have all stopped working. Nothing was working. She tried them a week apart. Benadryl worked for 3 days and then it stopped. Then she tried Zyrtec, which worked for a day and then nothing. It worked for like a couple hours. Allegra worked for maybe 3 hours and then it stopped. Allegra and Zyrtec were the small count bottles and Benadryl was a box of 8, 9 or 10. Patient did not have medications with her at time of call and cannot provide, NDC, Lot and Expiry. Is a sample of the product available to be returned, if requested reported as yes for all products and packaging sealed and intact was reported as yes for all products. She did not know what she was supposed to do. She was calling to see when the follow-up was and what was her next step. She wanted to know if there was a way, she can reverse this on her. She wanted to know if she should go and take Moderna or not and should she take Johnson and Johnson. She did not know what to do at this point. She would like a call back on Tuesday if possible. patient notified to call back on specific day was not guaranteed. Patient was given with Covid-19 phone number to call back. The outcome of the events was reported as not resolved and for rash outcome was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.  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.