Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dizziness, Heart rate decreased, Respiratory rate decreased
Clinical narrative: dizziness; slow breathing; she has an allergy; slow heart; This is a spontaneous report from a contactable consumer (Patient).   A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported), (age 66-year-old at vaccination) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included allergy to vaccine (she did have all the severe allergic symptoms with other vaccines but not with the Covid vaccine) from an unknown date and unknown if ongoing. Concomitant medication(s) included omeprazole (OMEPRAZOLE ABBOTT) and famotidine (FAMOTIDINE ACID REDUCER) was taken for an unspecified indication, start and stop date were not reported. Historical Vaccine includes flu vaccine on an unspecified date. On an unspecified date patient experienced dizziness, slow breathing, she has an allergy, slow heart. The caller stated she had the first dose of the vaccine and about 30 minutes after the vaccine she had some symptoms but said it was not a major reaction. She said she felt dizziness, slow breathing and "heart" but all was very light and controllable. She said it happened for 45 minutes to an hour and then she felt fine. She stated she is concerned about her second dose. She stated she is hearing from others that you should have fever and headaches. Others have a little more than that. Other people she knows have gotten 2 doses and still got Covid (and it was past 2 weeks after their vaccine). She said that  said that the second dose gives some kind of reaction like fever and pain and dis-comfort. The caller asked, based on her symptoms will her reaction be more intense after the second dose, She stated she is taking Omeprazole 20 mg and Famotidine, and no one asked her what medications she was on. She stated she has had an issue with serious allergies and has had an allergic reaction to the flu vaccine- her arm swelled tremendously, and they observed for an hour 3 years ago. She stated she did have all the severe allergic symptoms with other vaccines but not with the Covid vaccine. It was reported that PI section 6 explaining that many of the symptoms were reported more frequently after the second dose during the clinical trials but that each person is different and may react differently to the vaccine. Referred to HCP to discuss any symptoms she experienced prior to getting the next dose. The caller asked if Omeprazole is a medication, she should not be on to be able to get the vaccine. It was reported that it is not listed as a contraindication to receiving the vaccine from PI section 4 (also not listed in section 10). The caller asked if Famotidine is a medication, she should not be on to be able to get the vaccine. It was reported that it is not listed as a contraindication to receiving the vaccine from PI section 4 (also not listed in section 10). The caller stated if you get both doses of the vaccine, I thought you wouldn't get Covid How would someone get Covid after getting the vaccine. It was reported that Read from attached document "the results of this ongoing clinical trial have shown that, starting 7 days after the second dose of the vaccine, the Pfizer-BioNTech COVID-19 Vaccine was 95 percent effective in preventing COVID-19 infection in participants who did not previously have COVID-19 infection." Explained that it may not work for everyone and medical history may play a role in this, for example people that are immunocompromised may have a diminished response (PI section 5.2). Reporter states she is calling about the Pfizer COVID Vaccine and states she had the 1st dose of the vaccine recently and had issues with breathing because she has an allergy. Reporter states she is wondering if based on this situation, if she had the 1st dose of the Pfizer COVID Vaccine that failed, and she has issues of breathing and if she does not get the 2nd dose what would be the circumstances. States she is a little nervous with all of this situation and she has family that got the Pfizer COVID Vaccine and then got Covid; clarifies to state they are not family but are close friends and states she has no patient information, lot numbers, expiration dates or NDC numbers to provide for her friends or for their Pfizer COVID Vaccines. Caller states she called the main doctor who is her regular doctor to make sure there was no conflict with her getting the Pfizer COVID Vaccine and especially the fact that there was not a guarantee for the vaccine that it may prevent covid or not taking the risk of going to get the 2nd shot. States she has seen people go for the 2nd shot of the Pfizer COVID Vaccine and the vaccine hurts people and she sees people with very strong side effects; caller states she has no patient information to provide and no lot numbers, expiry dates or NDC numbers for those patients' Pfizer COVID Vaccines; states this was just conversations and comments she has had and the people would say they had the 1st dose or the 2nd dose and what those people said was that the side effects were going all over their bodies and they had a little fever and body aches and pains; no further details provided by the caller. Caller was asked for the lot, expiry date and NDC for her Pfizer COVID Vaccine and states she cannot find this information on her paperwork. The outcome of the events was unknown on an unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.