Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FH8028) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, first time 04Apr, The first time you know typical soreness), for COVID-19 Immunization, reaction(s): "soreness"; Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "every time she receives the shot, the symptoms worsen"; Bnt162b2 (DOSE 2, the second time it was a full blown feeling like I have the flu with a full grade fever), for COVID-19 Immunization, reaction(s): "feeling like I have the flu with a full grade fever", "feeling like I have the flu with a full grade fever". The following information was reported: EAR PAIN (non-serious), outcome "unknown", described as "my ear canal or my ear just started swelling to the point that it was painful and I could not"; HYPOACUSIS (non-serious), outcome "unknown", described as "I had my ears swell up to the point you cannot hear in any ears now/ I basically lost hearing for over a week"; EAR SWELLING (non-serious), outcome "unknown", described as "I had my ears swell up to the point you cannot hear in any ears now/ my ear canal or my ear just started swelling". The events "my ear canal or my ear just started swelling to the point that it was painful and i could not", "i had my ears swell up to the point you cannot hear in any ears now/ i basically lost hearing for over a week" and "i had my ears swell up to the point you cannot hear in any ears now/ my ear canal or my ear just started swelling" required emergency room visit. Therapeutic measures were taken as a result of ear pain, hypoacusis, ear swelling. Additional information: Call was transferred from Pfizer. As per agent, caller was experiencing side effects from the COVID vaccine and she wanted to know if she should proceed with the booster. Caller stated that she was solely vaccinated with the Pfizer COVID vaccine and each time, the symptoms or reaction was worst. Caller mentioned that first time 04Apr, the second time it was a full blown feeling like she had the flu with a full grade fever, then the third time she had her ears swell up to the point cannot hear in any ears now. Caller mentioned that she seek urgent care and she was told they never saw anything like that and they sent her to ER. Caller stated that ER said the same that they never saw anything like that. Caller added that after consultations, she was prescribed with a steroid drops and actually got hearing for about the week. Caller mentioned that now it is time for the second booster, is it advised to the second booster or switch to other vaccine. After providing response, caller stated that she think she fall under the category of those who shouldn't take the vaccine. Caller also mentioned that every time she receives the shot, the symptoms worsen. Caller also added that she seek medical advise from her doctor and they don't know what to do as well and referred her to Pfizer MI. It was reported that the COVID-19 vaccine was a Pfizer product and NDC, UPC number and expiry date of vaccine was unknown. It was reported that the patient took other products. Consumer stated that she just had a quick question. In Nov she had her first booster and had a horrible reaction. She was taking Pfizer the whole entire time. She took the Pfizer first two and the booster was in Nov and the reaction she had that her ear canal or ear just started swelling to the point that it was painful and could not hear and then went to urgent care and they said they never saw anything like that and then went to, this is within the 24 hours of receiving the booster and then went to the ER they sent her there and they said they never heard of such a thing and they ended up giving steroid antibiotic drop (treatment). She basically lost hearing for over a week and now its up to do her second booster. She asked if she can continue with Pfizer or should switch to different like Moderna (Unspecified medication) because each time it got worse. The first time it was typical soreness, the second time was actually Flu like symptoms and then the third was the bad reaction. Consumer was informed about the role of the Pfizer Drug Safety and Pfizer Medical Information Department for the concern. Consumer was provided with the contact for Pfizer Medical Information as (number), Option 3, and was informed about the timings as Monday to Friday, 8 am to 9 pm, as per EST. Follow up: Consumer stated that this has been a few months so she just want to know what she should do and asked for advise. Consumer was informed to contact Pfizer Medical Information. Medical conditions and Concomitant medications: Consumer stated she have Pre-diabetes, Blood pressure and Cholesterol medication (medications name not clarified over call). No Lab data was reported. Treatment: Consumer stated that she was given Ear drop to fix the situation or alleviate the situation. The patient did not receive any prior vaccinations.  Follow-up attempts are completed. No further information is expected.