Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Heart rate, Hypersensitivity, Hypertension
Clinical narrative: feeling dizzy; face turned cherry red; throat started shutting; Heart was pounding fast/My heart was beating really fast; BP was extremely high/Blood pressure was extremely high; I was really pale; Throat was like something was getting stuck in my throat; Nauseated; Diarrhea; possible allergic reaction to Pfizer; face turned cherry red, it was 'throbbing'; throat was like 'scratchy'; Headache; it hasn't gone away; This is a spontaneous report received from a contactable reporter (consumer or other non HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 01Nov2021 09:30 (Lot number: FE3590) at the age of 40 as dose 1, single for covid-19 immunization. Relevant medical history included: "allergic to iodine" (unspecified if ongoing); "allergic to seafood" (unspecified if ongoing); "allergic to shellfish" (unspecified if ongoing); and "allergic to salt" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: prednisone, reaction(s): "allergic to prednisone"; and steroid, reaction(s): "allergic to steroid".  The following information was reported: DIZZINESS (medically significant) with onset 01Nov2021, outcome "unknown", described as "feeling dizzy"; ERYTHEMA (medically significant) with onset 01Nov2021, outcome "recovering", described as "face turned cherry red"; THROAT TIGHTNESS (medically significant) with onset 01Nov2021, outcome "unknown", described as "throat started shutting"; PALPITATIONS (medically significant) with onset 01Nov2021, outcome "unknown", described as "Heart was pounding fast/My heart was beating really fast"; HYPERTENSION (medically significant) with onset 01Nov2021, outcome "unknown", described as "BP was extremely high/Blood pressure was extremely high"; PALLOR (medically significant) with onset 01Nov2021, outcome "unknown", described as "I was really pale"; SENSATION OF FOREIGN BODY (medically significant) with onset 01Nov2021, outcome "unknown", described as "Throat was like something was getting stuck in my throat"; NAUSEA (medically significant) with onset 01Nov2021, outcome "unknown", described as "Nauseated"; DIARRHOEA (medically significant) with onset 01Nov2021, outcome "unknown", described as "Diarrhea"; HEADACHE (medically significant) with onset Nov2021, outcome "not recovered", described as "Headache; it hasn't gone away"; HYPERSENSITIVITY (medically significant) with onset 01Nov2021, outcome "not recovered", described as "possible allergic reaction to Pfizer"; FACIAL PAIN (medically significant) with onset 01Nov2021, outcome "recovering", described as "face turned cherry red, it was 'throbbing'"; THROAT IRRITATION (medically significant) with onset 01Nov2021, outcome "unknown", described as "throat was like 'scratchy'". Clinical course: Patient received the first dose of the Pfizer COVID-19 vaccine 01Nov2021. Patient was afraid and concerned to get the second dose because patient had a severe reaction to the first one. After receiving the vaccine at 9:30 AM, three hours later patient started feeling dizzy, face turned cherry red and throat started shutting. She also expressed she had to clear her throat. Heart was pounding fast. She did take Benadryl before arriving to the ER. Face was puffy cherry red, and BP was extremely high and the people in the ER didn't know what to do. They gave me IV fluids and Tramadol. After the treatment, she started feeling better and face wasn't as cherry red. The redness calmed down. The next day, she was really pale (also reported as occurring on 01Nov2021). She wanted to know Pfizer can provide her an exemption letter for the second dose of the Pfizer COVID-19 vaccine. She went to see her doctor who referred her to the allergist. The allergist explained the reaction she had was not a severe allergic reaction. She was not able to obtain the exemption letter from her doctor. She has all the notes that were taken in the ER department but unfortunately on the notes it did not state she had an allergic reaction but a possible allergic reaction to Pfizer medical information (01Nov2021). She explained she took Benadryl before getting to the emergency room this may have masked her allergic reaction.  She was allergic to many medications. She was allergic to iodine, seafood, shellfish, prednisone, steroid and salt. She mentioned the vaccine Pfizer COVID-19 vaccine, Moderna and Johnson do contain salt. This may have caused her to react. She believed she had an allergic reaction. She did not want to get the second dose. She was afraid she would be dead or have to return back to the ER after receiving the second dose. She also asked if a reduced second dose can be administered which was a suggestion made by her doctor. Patient was advised that it is not recommended to administer the vaccine in any other way then described in the prescribing information. A reduced dose has not the been authorized as per the fact sheet. Patient was concerned about the Pfizer COVID Shot. She took it on 01Nov2021 of this year that was the 1st dose, it was not booster, it was the first shot. She did not get no reactions into let's say (incomplete sentence). 3 hours later (01Nov2021), she got like, face turned cherry red, it was 'throbbing' and my heart was beating really fast and throat was like 'scratchy' like it was like something was getting stuck in throat. So she decided to go to the ER because she thought it was allergic reaction or something (consumer was unsure, hence not captured as event), she didn't know, she was confused like they don't know what to do, they only gave fluids, IV fluids (treatment) and they gave me 'Tramadol' (consumer was unsure). Blood pressure was extremely high when she went there (Further clarification unknown if consumer had high blood pressure prior taking the vaccine or after hence captured as event).  She did not know and so once they gave her that (Not clarified over the call), her body calm down and stuff you know and the redness did not go right away. The redness on face went away the next day like slowly. The first day after she got the shot, she started feeling nauseated, the normal symptoms that as mentioned of side effects right like nauseated, diarrhea and stuff like that right. So what patient was asking though was my next shot it on 22nd, it was yesterday right, she went there, they were going to give it to her they seen that she went to the ER because of the COVID Shot that she had on the first, they didn't give it to her they said they need to do more research to give them a copy of the 'exemption' form, something from the CDC or something so that the doctor can fill it out but they are saying this is a rare allergic reaction because it didn't happened after 30 minutes, it happened like 3 hours later, still she wanted to research on it and on this CDC website and so it mentioned something about 'hypertension' hyper something to hypertension or something (consumer was unsure) like that "your body goes through when we get that and that's indicating like an allergic reaction your heartbeat pounding, you are flushing like really red, like cherry red and you are having blood pressure like extremely high or something (Further clarification unknown)". Patient just trying to figure out because she was just talking to her doctor, they do not know what to do like they are confused like they are saying that's not an allergic reaction. They are expecting her not to believe which she thought as an allergic reaction because she have a lot of allergies to a lot of medication (Unspecified Medication), a lot and her chart has a lot of allergies medications Prednisone, shellfish: allergic to Iodine, allergic to 'Gadavist' (Not clarified over the call), allergic to steroids (Unspecified Medication),  allergic to all this kind of stuff and the ingredients that patient saw in Johnson and Johnson, Moderna and Pfizer, they all containing 'salt' on them but they were telling her that's all involved with the (incomprehensible voice) that they put in her and she did not agree on that. She was scared to take the second dose because they think everything was going to be worse. Once they gave her the first one, they told her the second one is going to be worse, "you are going to feel more symptoms and you are going to feel this and that". So if the first one gave her that reaction rapidly within 3 hours, the second one is going to do the same thing too. She was going to go straight to the ER and that is not her thing to do at all. She did not want heartbeat to be raising high, she did not want to get into this stressful moment so she was trying to get into the bottom line what can she do. The events "feeling dizzy", "face turned cherry red", "throat started shutting", "heart was pounding fast/my heart was beating really fast", "bp was extremely high/blood pressure was extremely high", "i was really pale", "throat was like something was getting stuck in my throat", "nauseated", "diarrhea", "headache; it hasn't gone away", "possible allergic reaction to pfizer", "face turned cherry red, it was 'throbbing'" and "throat was like 'scratchy'" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: allergy test: (Nov2021) unknown result, notes: I did have some allergy testing for blood; blood pressure measurement: (01Nov2021) extremely high; heart rate: (01Nov2021) really fast. Therapeutic measures were taken as a result of dizziness, erythema, throat tightness, palpitations, hypertension, pallor, sensation of foreign body, nausea, diarrhoea, headache, hypersensitivity, facial pain, throat irritation.  Follow-up attempts are completed. No further information is expected.