Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Anxiety, Confusional state, Dysphagia, Lip swelling
Clinical narrative: experienced confusion/brain confusion; Swelling of face/ face was swollen; problem with swallowing/difficulty swallowing; sensitivity with PEG; anxiety; lip and face swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101871734.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EP6955) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Verbatim: Allergy; "allergic to sulfa" (unspecified if ongoing); "allergic to insect" (unspecified if ongoing); "Hives" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot. The following information was reported: DYSPHAGIA (non-serious) with onset 17Mar2021, outcome "recovered" (2021), described as "problem with swallowing/difficulty swallowing"; POLYMERS ALLERGY (non-serious) with onset 2021, outcome "unknown", described as "sensitivity with PEG"; CONFUSIONAL STATE (non-serious) with onset 17Mar2021, outcome "recovered" (2021), described as "experienced confusion/brain confusion"; SWELLING FACE (non-serious) with onset 17Mar2021, outcome "recovered" (2021), described as "Swelling of face/ face was swollen"; ANXIETY (non-serious) with onset 2021, outcome "recovered" (2021), described as "anxiety"; LIP SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "lip and face swelling". The events "problem with swallowing/difficulty swallowing", "sensitivity with peg", "experienced confusion/brain confusion", "swelling of face/ face was swollen", "anxiety" and "lip and face swelling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysphagia, confusional state, swelling face.  Additional information : The reporter stated that she had swelling of her face at around 8 minutes after she got the first dose of the vaccine, it was within the first ten minutes. She says she felt like she had difficulty swallowing and she had some water so she was trying to drink the water, but she didn't know if she was just stressed. She says she should have gotten the nurse, when you have this you have confusion and it affects the brain, and have some anxiety and confusion. She says when she looks back she asks herself why didn't she contact the nurse in case there were problems and she needed an EpiPen or something like that. She says no treatment was done, and the swelling, confusion, and difficulty swallowing went away on its own. She says the confusion and anxiety lasted an hour probably. She says when she had the allergy test, which she had on the same side, her face and lips swelled on the same side when she got the test, which it was a smaller quantity for the test, with some level of confusion lasting an hour or two and the swelling went down in 30 minutes or something. She was trying to decide if she needs to get the second dose of the vaccine or not, now that she has been thru this process she was not going to get it, but it seems the COVID pandemic has gotten worse with Omicron variant, and it doesn't seem like it is getting better. She says another interesting dynamic for this is that when you are have allergies and go to get flu vaccines an allergist can give those to you and monitor you there in their office, but unfortunately her allergist can't get the COVID vaccines, only with held can get it. She says her internal medicine doctor said they would write her a prescription to pick it up and take it to her allergist's office but her with held said when she came to get it that she can't get it to carry to her allergist because it wasn't stable enough for her to be able to transport it. She says they normally could do a vaccine like this with constant supervision, and is wondering if they might make it possible for people who have allergies to do it that way where they could get it and take it to the allergist, like if they have some kind of plans for the future to make this possible.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.