Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: Broke out really bad; Tooth hurting; Cheek swollen; A little tired that night; doctor told her the steroids have probably counteracted the vaccine: unspecified steroids; I have an abscess in my tooth; following Monday flare up of reaction with antibiotic occurred and that is when she received the prednisone treatment.; This is a spontaneous report from a contactable consumer or other non-health professional (Patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202) via an unspecified route of administration, administered in arm left on 04-Mar-2021 (age at vaccination 62 years) as dose 1, single for COVID-19 immunization, PREDNISONE, oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included asthma and abscessed tooth. Concomitant medications included ampicillin sodium; sulbactam sodium. The patient received second dose of BNT162B2(COMIRNATY, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 25-Mar-2021. On unspecified date in 2021 patient experienced following Monday flare up of reaction with antibiotic occurred and that is when she received the prednisone treatment, doctor told her the steroids have probably counteracted the vaccine: unspecified steroids, I have an abscess in my tooth and on 04-Mar-2021 Tooth hurting, Cheek swollen, A little tired that night on 08-Mar-2021 Broke out really bad. It was reported that she thought she had an abscess in her tooth. She was put on an antibiotic, Ampicillin, and 5 days later had reaction: "rash, very itchy, welts, red all over, all over at different times". she discontinued antibiotic. Then she went back to my doctor because "Her mouth was still hurting, she says her doctor put her "back on the ampicillin, then 5 days later same reaction, but worse". She was treated with a Prednisone "shot" and given oral prednisone. She got her 1st dose of vaccine on 4-March-2021 (Thursday), during her 2nd round of ampicillin. She says, following Monday flare up of reaction with antibiotic occurred and that was when she received the prednisone treatment. She was told by her doctor that the COVID vaccine wouldn't work because she was on the prednisone. She was asking for information about vaccine while on prednisone. Made her aware that Prednisone could affect the immune system. Made her aware that she should/can still be offered the 2nd dose as scheduled unless her doctor was telling her otherwise. Made her aware that she should always discuss medication uses with her HCP. She had 2nd dose scheduled for 25-March-2021. She was asking if she can get the 2nd dose as scheduled since she took prednisone. She was asking "if she were to wait for(2nd) dose. Should she re-do series. can that hurt me. Encouraged her to speak with HCP about needing to delay 2nd dose based on her recent medical situation/medications given. Made her aware of information attached: who should not get the vaccine. Made her aware that if her doctor decides she needs to delay vaccination dose, there was no information about re-starting vaccine series. On 08 Mar-2021, patient experienced broke out really bad and on 04-Mar-2021, patient experienced tooth hurting, cheek swollen, a little tired that night. Doctor told her the steroids have probably counteracted the vaccine: unspecified steroids. Caller reported that she doesn't know who to get a hold of and stated that she finally got her COVID vaccine on 25-Mar-2021 and had no problems. Clarified that caller was speaking of the Pfizer COVID-19 vaccine as well as date of first vaccination, which was 4-Mar-2021. Further clarified that second dose of COVID-19 vaccine is scheduled for 25-Mar-2021.Caller reported that she has an abscessed tooth and that her doctor had her on antibiotics. She stated that she had allergic reaction and her doctor had to put her on oral steroids and she had to get a steroid shot. Her doctor told her that the steroids have probably counteracted the vaccine and that she may have to wait for 5 to 6 weeks and start the process all over again. Caller stated that she doesn't want to screw something up by getting the second one, but that she doesn't want to not be vaccinated. She is inquiring if it is ok for her to get the second dose of the vaccine and if the steroids could have affected the efficacy of the first vaccine. Caller reported that she is so disillusioned, that she has been trying to get a hold of the county where she received her vaccine, emailing them, but has not been able to get a hold of anyone. She stated that last night, 14-Mar-2021 she was reading the information she was provided when she received her vaccine and found the number to Pfizer, so she reached out to see if we would be able to answer her question. Caller was unable to provide NDC number or expiration date as they were not listed on her vaccine card. Caller stated that she is not an essential worker, but she is a hairdresser and that she sees 10-12 people per day and is in close contact with them, within 6 inches. Caller stated that she sees people all day long and that she is lucky that she hasn't come down with it as she has asthma and is 62. Caller reported having no problems following the COVID-19 vaccine other than being a little tired that night, stating that she is always tired though. Caller stated that she had the tooth abscess a long time before receiving the vaccine, but before receiving the vaccine, her tooth started hurting again and her cheek was swollen. She reported that her dentist retired during COVID and that she went to see her physician. She stated that she had been on antibiotics when she got the vaccine and that 4 days later she broke out really bad and was in the doctor's office the following Monday, 8-Mar-2021.Clarified she was on the antibiotic way before getting the vaccine, she was on antibiotics for it because she knew there was something going on, and she went to her doctor after 5 days on antibiotics, since she had the terrible rash and reaction to it, then she was off the antibiotic for a while, then it came back 2-3 weeks later- she was hurting and her cheeks were swollen, then she got the vaccine and this all happened, and the doctor put her on it, and then he said he didn't think vaccine would be good anymore. Caller stated that she broke out really bad 4 days after receiving vaccine. She reported that she told her doctor that she would not be taking Ampicillin again, she was in this office two days in a row, she couldn't quit itching. Caller declined to file safety report, stating that today is her day off and that she has to take her daughter to the doctor. She reported that she had been on the phone for an hour and just wanted to speak with someone about her concerns. Safety report filed with the information provided by the caller. Therapeutic measures were taken as a result of abscess which included ampicillin. The outcome of all the events was unknown. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: To update drug information.