Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear, nose and throat examination, Eastern Cooperative Oncology Group performance status, Fatigue, Hypersensitivity, Illness
Clinical narrative: I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine.; she can't talk, it's closing up her throat,; she can't talk, it's closing up her throat,; taste sodium in my mouth constantly; coughing; got home and I've been sick ever since.; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration administered on right arm on 07Apr2021 at 13:30 (at the age of 62-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing Allergies with This was under control, ongoing asthma with This was under control, meniere's disease from 1989 and ongoing with This was under control, have 2 broken knees. Patient knows how to control this condition, she didn't need Prednisone prior to onset of these adverse events, Low immune system with She has an immune deficiency so her immune system very low, like 300., Respiratory illness, Genetic/chromosomal abnormalities, Endocrine abnormalities with endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant to AE reported as None.  History of all previous immunization with the Pfizer vaccine considered as suspect reported as Both doses of product documented in Pfizer Suspect Vaccine and Vaccination fields. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiry date: 31Jul2021) via an unspecified route of administration to the right arm on 13Mar2021 at 13:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine other than dose 1 of 2 of the Pfizer-BioNTech Covid-19 Vaccine. Regarding concomitant products and other medical conditions patient reported none other than just her inhalers which doses of had to be increased in response to symptoms after first and second doses of Pfizer-BioNTech Covid-19 Vaccine. Concomitant medication included tiotropium bromide (SPIRIVA) taken as Dose increased to twice in the morning daily for an unspecified indication from an unspecified start date and ongoing, (Lot number: 0014678, ; Expiration Date: Jan20230); fluticasone propionate, salmeterol xinafoate (ADVAIR) 500 taken as Dose increased from once daily to twice daily an unspecified indication from an unspecified start date and ongoing; azelastine hydrochloride (Lot Number: 3N2E, Expiration Date: Feb2022), fluticasone propionate (DYMISTA) taken for an unspecified indication from an unspecified start date and ongoing (Lot number: GA00510, Expiration date: May2022); prednisone (PREDNISONE) taken for an unspecified indication with quantity of 27, Dose: 3-20mg daily for 7 days, then 2-20mg daily for 2 days, then 1-20mg daily for 3 days and Ongoing therapy. She also used a nose spray that didn't work so they switched her back to Dymista nose spray.   Consumer stated that she received both doses of Pfizer's COVID vaccine and had reactions to both of them. Consumer stated that, "The second dose was even worse. They put her on Prednisone. She did not know if she should be tested again or not? She was sitting up but she could not walk around anywhere. She had 2 broken knees. She could not walk anywhere. After the second dose, they had to bring her to the hospital because she couldn't even walk to her car. She got home and she had been sick ever since. She had allergies too. She could not do anything. she had a hard time breathing. she was hesitant to get the 2nd one, but everybody said to get it. Her IgG level was down to 300 something. She was also tapering off of prednisone and she did not want to be tapering off it because it was worked well for her. She could tell by her breathing that it was helped her. She could taste sodium in her mouth constantly since she had got the vaccination." Second dose completed her prescribed therapy. Dates for Symptoms From 15Mar2021 to Ongoing Reported seriousness for Symptoms reported as Unspecified and the Symptoms was reported as worsened. Patient's doctor dropped her last week, told her she didn't know what to do with her, and that this was too stressful.  Onset of symptoms following first dose of Pfizer-BioNTech Covid-19 Vaccine was on 17Mar2021. She couldn't breathe very well when she went in for the first dose of Pfizer-BioNTech Covid-19 Vaccine. She was ok the first day after the first dose of Pfizer-BioNTech Covid-19 Vaccine, seemed ok, arm didn't hurt; but then had onset of symptoms. She has been in bed the whole time since onset of symptoms, was in bed for over 2 weeks. She slept for 2 days straight, only got up for water and the bathroom. It was bad, getting hard to breathe. She had to use her emergency inhaler. The Pfizer-BioNTech Covid-19 Vaccine messed up her Meniere's disease. Doctor started patient on Prednisone for these symptoms, and Prednisone is really the only thing that clears up Meniere's disease because her ears was full and she could not get up. Prednisone helped her and I relayed in her 'rescue' inhalers (treatment) because she did 2 in the morning, two inhalers anyway when she started to feel better, she got her second one and it made her worst.  She did not eat anything salty or anything, the barometric pressure was not bad. It was really funny because she had just finished everything and it was a few days before she had to go get her second dose of Pfizer-BioNTech Covid-19 Vaccine shot. She was just starting to feel normal, at least normal for her, she could get up normal and drive. They gave her the second shot of Pfizer-BioNTech and it was like a double. She clarified as she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine.  She is tasting sodium in her mouth from the Pfizer-BioNTech Covid-19 Vaccine. She can't have much sodium which struck up the Meniere's disease really bad the second day after the second dose of the Pfizer-BioNTech Covid-19 Vaccine; her allergies in her head went bonkers. She could not talk, it was closing up her throat, she was coughing every time she eats or dinks, and she's having a "really bad" adverse reaction to the Pfizer COVID-19 vaccine after the second dose. They had to take her out of the hospital to her car in a wheelchair "right after" getting the second shot. She could not get more than 1000 mg of sodium a day, she tastes it in her mouth constantly, she could not get rid of it and it was "going through her system". She wanted to know what to do, since her doctor told her to contact Pfizer. She wanted to know what part of the vaccine is doing that, she assures it is sodium, because sodium is in her mouth 24/7 and she could not get it out, she could not have that much sodium in her body. It was still getting really hard to breathe. She is still taking the Prednisone she was initially prescribed and started on for the symptoms that started after her first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tapering off of Prednisone, and she shouldn't be tapering off, she thinks she needs to be Prednisone for some more days, maybe 3 more days, then she would be ok. It was prescribed as a 7-day burst of Prednisone. She mentioned that the only Prednisone that works on her is the Actavis manufactured Prednisone; her pharmacy orders it for her because they know that. She called the emergency room Saturday when she was really bad. They said they had a line there and it was going to be at least a 4 hour wait. With patient's low immune system, Meniere's disease and that she could hardly breathe she did not go to the emergency room because she could catch something and die while waiting. She decided she would just stay at home and rest. She has not had any Physician's office visit relative to event; she has a telephone appointment tomorrow to see if the doctor is going to be her doctor. She had to cancel her appointment with the doctor today because if she has something she doesn't want to spread it, she feels worse now and with the Meniere's she is tasting sodium in her mouth constantly from the Pfizer-BioNTech Covid-19 Vaccine, she does not eat a lot of salt. The flu shot takes her a couple of days, then she is right back up and Vaccination Last dose on Oct2020. Consumer stated that she has 'Meniere's' disease (History) and it made her worse. The patient underwent lab tests and procedures which included IgG level: 300. Reporter stated the seriousness for the events was Unspecified. Seriousness of event Meniere's disease aggravated was medically significant. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.