Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Swelling
Clinical narrative: Headache; First day after vaccination as feeling the blood vessels on the front of her head expand and feel swollen, and states that this feeling was also in the back of the head/ Feeling like deep vessels in front of her head; Dizzy/Dizziness; She felt dizzy, with light seeming to make it worse; Eyes were "swollen and red."; Eyes were "swollen and red."; She want to sleep on more often; This is a spontaneous report from a contactable consumer. This 55 year old female consumer (patient) reported for herself that: A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE;Solution for injection;), dose 1 via an unspecified route of administration on Apr2021 as SINGLE DOSE for covid-19 immunisation.Medical history included seasonal allergy from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing Her daughter, who has not yet received the vaccine, has seasonal allergies to things like pollen and certain food allergies as well, such as allergies to shrimp and crab , seasonal allergy from an unknown date and unknown if ongoing Her daughter, who has not yet received the vaccine, has seasonal allergies to things like pollen and certain food allergies as well, such as allergies to shrimp and crab , food allergy from an unknown date and unknown if ongoing Her daughter, who has not yet received the vaccine, has seasonal allergies to things like pollen and certain food allergies as well, such as allergies to shrimp and crab. The patient's concomitant medications were not reported. The patient experienced headache , first day after vaccination as feeling the blood vessels on the front of her head expand and feel swollen, and states that this feeling was also in the back of the head/ feeling like deep vessels in front of her head , dizzy/dizziness, she felt dizzy, with light seeming to make it worse  eyes were "swollen and red." , eyes were "swollen and red.", she want to sleep on more often on Apr2021 Caller states that her daughter, who has not yet received the vaccine, has seasonal allergies to things like pollen and certain food allergies as well, such as allergies to shrimp and crab. Caller would like to know if because of her daughter's allergies, which she state are "severer than mine", it would be for her to receive a dose of the Pfizer BioNTech COVID-19 vaccine.Response: Spoke from the attached document regarding contraindications to receiving a dose of the vaccine and sent list of ingredients to caller via email that her daughter could review with a HCP to help determine if there is anything in the vaccine she should be aware of based on her allergies.Caller is a 55 year old female who is calling on behalf of her 20 year old son who received his first dose of the Pfizer BioNTech COVID-19 vaccine this morning. Caller states that her son has autism and when he received his vaccination this morning, she was holding him and states that after the nurse injected the needle and then pulled it out, she saw "water" and fluid on the floor and then reports blood came out that took "4-5 cotton balls" to clean up. Caller is concerned now because she does not believe her son got the full dose of the vaccine and wants to know if there is a way to tell if he did get any of the first dose. Caller mentions the possibility of him getting an antibody test doneCaller also reports that she and her husband received their first doses of the Pfizer COVID-19 vaccine last week and states that her husband did not have any symptoms but she did. She reports having a headache that she describes on the first day after vaccination as feeling the blood vessels on the front of her head expand and feel swollen, and states that this feeling was also in the back of the head. She reports that the second day she felt dizzy, with light seeming to make it worse and reports it occurring during the day. She also reports that her eyes were "swollen and red." She states that now, one week later, it has gotten better, stating at one point that she still felt dizzy at times and then stating later that she no longer has any symptoms of dizziness. She reports that overall her reaction was "very minor" and is not sure if it is caused by the vaccine itself or could possibly be due to her seasonal allergies (she states that she read online that it is "probably allergies"). She also mentions that she had a friend who received the Pfizer COVID-19 vaccine and said her arm was sore after. She states that this friend told her that side effects were worse after the second dose of the vaccine. DSU: E-transmitting AE as caller declined warm transfer.Response: Let caller know that there is no information available to speak from regarding how to tell if her son got a full first dose of the vaccine. Spoke from the attached documents regarding how the first and second dose of the vaccine work and CDC's recommendations that antibody testing not be used as a form of testing to see if immunization occurred. Referred caller to HCP for further guidance. Let caller know that she could have her son's HCP call us himself/herself on her son's behalf to see if there is any further information that could be provided to a HCP specifically. Provided her with option #3 and also gave her this INT number to use as reference.Question: Caller states that her son has autism and when he received his first dose of the Pfizer BioNTech COVD-19 vaccine this morning, she was holding him and states that after the nurse injected the needle and then pulled it out, she saw "water" and fluid on the floor and then reports blood came out that took "4-5 cotton balls" to clean up. Caller is concerned now because she does not believe her son got the full dose of the vaccine and would like to know if it would be safe for him to get the second dose in this situation. She is concerned about any side effects that he may experience with the second dose if he did not truly receive a first dose of the vaccineResponse: Let caller know that there is no information available to speak from regarding the safety of getting the second dose after a possible invalid first dose. Spoke from the attached documents risks associated with getting any dose of the vaccine. Referred caller to HCP for further guidance. Let caller know that she could have her son's HCP call us himself/herself on her son's behalf to see if there is any further information that could be provided to a HCP specifically. Provided her with option #3 and also gave her this INT number to use as reference.Question: Caller would like to know if the Pfizer BioNTech COVID-19 vaccine works on the new variants. Response: Spoke from these two press releases regarding variants: Question: Caller states that she was told that if someone has an allergy to vaccines that are similar to the COVID-19 vaccines, such as flu or tetanus vaccines, it would still be ok to get the Pfizer BioNTech COVID-19 vaccine. Caller would like to know if this is true because she does not know what vaccines would be considered "similar" to the Pfizer BioNTech COVID-19 vaccine.Response: Spoke from the attached document regarding contraindications to receiving a dose of the vaccine and let caller know that because I am only trained to speak about the Pfizer COVID-19 vaccine, I could not safely say what other vaccines out there would be considered "similar." Referred caller to HCP for further guidance.Question: Caller states that she heard that the second dose of the Pfizer BioNTech COVID-19 vaccine is worse in terms of side effects and would like to know if this is true.Response: Spoke from the FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION PFIZER-BIONTECH COVID-19 VACCINE Prescribing Information Tables 1-4 (LAB-1457-7.0. Revised: 06 April 2021) to let caller know that overall there was a greater percentage of participants who reported side effects following the second dose versus the first dose in the clinical trial.Call was transferred .Transferring agent stated, "She already get the first dose. I am not sure what date actually she had it. After the first dose she felt headache, dizziness and she said that she kind of feeling like deep vessels in front of her head and she kind of feel she would like she want to sleep on more often."When paraphrased the concern, consumer stated, "I had a vaccine actually two weeks ago. So last week I week a lot of headache."In response to file safety report, consumer stated, "My question is this is normal reaction for vaccine Consumer was provided with the number of Pfizer Medical Information timings 8 am-8 pm Monday- Friday, 9 am-3 pm Saturday-Sunday as per EST.Consumer hung up the call abruptly.So further probing could not be done. Hence, Product details (LOT#, Expiration date, NDC#, UPC#) and other patient's details were unknown.Limited information was available over the call. outcome of the events was for Dizzy/Dizziness,She felt dizzy, with light seeming to make it worse was recovered outcome of Eyes were "swollen and red was recovering outcome of other events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.