Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Cystitis, Disease recurrence, Dizziness, Feeling abnormal
Clinical narrative: Confused/couldn't think straight; having it rough, I could hardly make it to the kitchen/ I was afraid it wouldn't go away; Bladder infection; Make my Meniere's disease come back; My vertigo come back; Meniere's disease/vertigo; Ringing and buzzing is not as loud/ Ringing in ears/ Buzzing in ears; Dizziness; Pounding of heart; This is a spontaneous report from a contactable consumer. This case is 83-Year-old female consumer (patient) reported self.  An 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration on 13Jul2021 as (At the age of 83-years) single dose for COVID-19 immunisation. Medical history included lung disorder patient had a problem with my lungs, meniere's disease, make his Meniere's disease come back and his vertigo come back she had both conditions, before the vaccine, and the symptoms had subsided, vertigo all are from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that Caller is a consumer inquiring about side effects for the Pfizer Covid-19 vaccine. Caller reports she received her first dose of the Pfizer Covid-19 vaccine on 13Jul2021. Caller states she didn't know if it's going to make his Meniere's disease come back and his vertigo come back. The first dose made it all come back, she had those symptoms anyway. Some had sort of had left, but it made them come back. she was wondering if second shot is going to do the same. They came back and weren't so bad until she had to take antibiotic Friday night and Saturday when she got up, she was having it rough, she could hardly make it to the kitchen. But today she was better, not as dizzy, the ringing and buzzing is not as loud. She had little fearful, to get the second. Caller asks will it make it worse, or should I wait. Caller states You probably don't know if this would make it worse or not. You don't want to go through life being dizzy, can't drive. she just afraid the way she felt Saturday she was afraid it wouldn't go away. she just wants someone to tell, it's okay but she doesn't know how they can because this is so new. she had a problem with his lungs and that's why she didn't get the vaccine and then his pulmonary doctor said it was okay. She will call his primary care doctor and see what she says. Response: Provided disclaimers and spoke from the attached documents. Explained to caller than Pfizer's recommendations are 2 doses, 3 weeks apart. Explained CDC considerations and explained that Pfizer is independent of that information. Provided data from the FAQ and explained the contraindication we have is for anyone who had a severe allergic reaction to previous dose or any ingredient in the vaccine. Encouraged caller to contact her HCP for further guidance. Invited caller to call us back with any further questions and explained that her doctor could call us as well if she had questions. Survey offered. Later upon Follow up Caller states she received the Pfizer vaccination on 13Jul2021, EW0168. Caller states she is due for her second vaccine on 04Aug2021. Caller states she is 83 years old and has Meniere's Disease and Vertigo. Caller states she had both conditions, before the vaccine, and the symptoms had subsided, after the vaccine, she again experienced ringing in her ears, pounding heart, buzzing in her ears all the time. Her Meniere's Disease and Vertigo came back. Caller also states she was dizzy, she went to the doctor for a bladder infection and was prescribed Cephalexin 500 mg. Caller states she took the medication on Friday at 7 am and on Saturday, she felt out of it. Caller states she was dizzy and couldn't think straight and was confused. Caller also states she felt this way yesterday. Caller states today, she is feeling better. Caller states she only has an pharmacy bottle. Caller cannot provide an NDC, Lot, or expiration date. Caller states she is hesitant to get her next vaccine. Caller states, she is not sure if she will feel worse. Caller asks, does she have to get her second vaccine within 3 weeks or can she wait longer. Caller agrees to be transferred to Medical Information. Caller declines to complete a safety report. Caller states she has a bad phone connection and asks to be called back on her cell phone. Report continues after successful outbound call was made. Later upon Follow-up it was reported that Caller received her first dose of the vaccine on 13Jul2021, and on 27Jul2021 she was diagnosed with a bladder infection. Caller asks if there is information on getting the second dose with a bladder infection? Caller states she still has the infection, is it ok to go get the shot or should she wait? Caller states she called her primary care physician, and they couldn't answer her question. E-transmitting potential duplicate AE for caller having a bladder infection after her first dose. The outcome of event bladder infection was not recovered, and outcome of all other event was recovering.  Follow-up attempts are completed. No further information is expected.