Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinusitis, Swelling face, Tinnitus
Clinical narrative: face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinus infection; Shortness Of Breath; pounding in my chest/throbbing in her chest; ringing in ears; flared up some digestive issues / digestive disturbances; flared up some digestive issues / digestive disturbances; red on left side/face redness; exhausted all the time; This is spontaneous report received from contactable female consumer (patient) reported herself. A 67 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) on 10Mar2021 17:30 at age of 67 years old at single dose in right upper arm for COVID-19 immunisation. Medical history included: last year February, she was really sick with bad sinus infection not knowing about COVID at the time. Sometime later she got these horrible digestive attacks, ended up in her stomach and esophagus, horrible attacks where she couldn't breath, she has had acid reflux in the past. digestive problems stayed with her a really long time, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. She tested in April last year, it was negative (not detectable). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No adverse events (AE) following prior vaccinations. Patient had first Pfizer covid vaccine on 10MAR2021, approximately 10 days to 14 days after the vaccine her face swelled up, numbness and red on left side, went to see my  doctor, he treated her with steroid and antibiotic for sinus infection, at the same time she had some shortness of breath and pounding in my chest, and had and still have ringing in ears since then, it kind of flared up some digestive issues she had last year. If she back up to last year February, she had a bad sinus infection, went to see allergist, family doctor and ENT, all treated her for sinus' before covid testing was even a thing, they didn't think of covid testing at the time. It ended up in her stomach and esophagus, horrible attacks where she couldn't breath, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity.  In March2020 her husband came home with covid, after that, talking to his doctor, she brought him meals outside of the door, it occurred to her that queried if this could have been covid. She tested in April last year, it was negative (not detectable), they were still not sure if it could have been covid. She was supposed to get the second vaccine, she postponed it, the numbness and swelling of face is gone, next shot was tomorrow. Since this was a delayed reaction, typically one to three days would be a reaction to the vaccine. she didn't associate it with the vaccine, asked if it could have been from the vaccine. She wanted to make sure that she was safe to get the second one. Response: Spoke from EUA factsheet for Recipients and Caregivers: LAB-1451-4.0 Revised: 06 April 2021: Sections: who should not get the PFIZER-BIONTECH COVID-19 VACCINE and what the risks of the PFIZER-BIONTECH COVID-19 VACCINE were. Spoke from attached VR Consumer- Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 vaccine). Your doctor/healthcare provider is in the best position to assess and advise you as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Patient calling about the COVID vaccine. She states that she had the first vaccine 10MAR2021, and 10 days afterwards her face swelled up. She had numbness in it and redness. She went to the doctor and the doctor thought that maybe it was a sinus infection. So she was treated for that. She states that she did have a few other symptoms. To make a long story short, she was suppose to have the last vaccine last Friday. She postponed it for a week (postponed getting the second shot for a week). She wants to know what Pfizer thinks about her getting her second vaccine and her side effects. She says that somewhere between the 10th and 14th day, after receiving the vaccine the symptoms started and that was why she did not think she had a reaction to the vaccine. She has not had anything like that before, it was sort of a delayed reaction. She states she is better now. She had a few symptoms after the face things started and the only thing that she still has now is ringing in her ears. She states it all started around the same time as her face issues, or might have started a little after that. She confirms everything but ringing in her ears have completely resolved. She states that she did have some digestive disturbances, shortness of breath, and throbbing in her chest after receiving the vaccine. She asks if she can go back a little bit to explain. She states that last FEB2020 she was really sick with bad sinus infection not knowing about COVID at the time. She went to her allergist, then her family doctor, and then an ENT. She states that it was nothing like she has ever had, it was really bad. Sometime later she got these horrible digestive attacks, she has had acid reflux in the past but it was nothing like this. In March her husband had COVID and tested positive for COVID. She decided to get tested and she tested negative. She wonders if she had COVID earlier but at that time they were not testing for COVID. Her digestive problems stayed with her a really long time, and she was still on the medications her gastrointestinal doctor put her on. They are hypersensitive esophageal medication. She states that she has been exhausted all the time. The rest of the story she has told already. She states that after the face thing happened she started getting those digestive issues again. Her friend suggested that she call Pfizer, so she is doing that. She confirms that the vaccine card does not have an expiration date, NDC, or dosing information. She states it says 0.3 ml, but she cant see a point, so she doesn't know if its just 03. She states she got the vaccine to lessen her chances of getting a severe disease, in case she ends up in the hospital. Also, to keep herself safe from other people. She states she wants the second one because husbands works with the public and she wants to be protected when he comes home. She states that she has those gastrointestinal disturbances and is on amitriptyline 10 mgs for that. She states she also takes something for her thyroid but she has no major health issues. She states that she had a endoscopy and a colonoscopy as well as blood work done but she doesn't have any of the results because they are in her Beaumont chart where she actually got the vaccine. All of this was pre-vaccine so she doesn't know how relevant it is. The patient did not require a visit to Emergency Room, but visit to Physician Office. The only thing similar had a sister who reacted to a shingles vaccine, She has no information about her sisters reaction to the vaccine. Outcome of event ringing in ears was not recovered, for others was recovered.      No follow-up attempts are needed. No further information is expected.