Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Heart rate irregular
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 72 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 21Apr2021 (Lot number: EW0158) at the age of 72 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Cataract surgery", start date: 01Jun2021, stop date: 01Jun2021, notes: Verbatim: Cataract surgery; "food allergies" (unspecified if ongoing), notes: Verbatim: she does have a lot of food allergies and medication allergies; "medication allergies" (unspecified if ongoing), notes: Verbatim: she does have a lot of food allergies and medication allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EL3302, Anatomical Location: Left arm), administration date: 30Mar2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "feeling at times like an elephant is sitting on her chest and when she takes a deep breath"; HEART RATE IRREGULAR (non-serious) with onset 30Apr2021 10:00, outcome "not recovered", described as "irregular heartbeat". The event "irregular heartbeat" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient asked if an irregular heartbeat was reported as a side effect to the Pfizer-BioNTech COVID-19 vaccine. She explained receiving this vaccine on 31Mar2021 and 21Apr2021. She explained 9 days following the second shot, she experienced a "very irregular heartbeat". She asked if the reported myocarditis and pericarditis could occur in older recipients of the vaccine and as the symptom she experienced. She asked if she should get the booster dose 7 months after getting her second dose of the Pfizer-BioNTech COVID-19 vaccine, and after she has experienced symptoms from the second dose. She asked for the dose of the Pfizer-BioNTech COVID-19 booster shot. She stated she was 72 years and 3 months old when she got the shot and she has been to the doctor's office and never noticed an irregular heartbeat before. The irregular heartbeat got increasingly worse for 6.5 months, but for the last 2 weeks it started calming down a bit. She did go see a cardiologist who did and echocardiogram and told her that her heart was totally normal, They also slapped a monitor on her and monitored her for 48 hours. The cardiologist said there was definitely an irregular heartbeat, but it was nothing to worry about. She is calling today to see if there is any chance this could be from the COVID shot because this all happened after the COVID shot? She was calling to let Pfizer know that this is what she experienced after the shot and she wanted to know if anybody else experienced this. She stated she decided to call after going to her cardiologist after having the echocardiogram and heart monitor put on her and she was told everything was okay. The cardiologist was not sure what was causing this, so the caller decided that she has to do some research herself. When probed for the outcome of the irregular heartbeat, the she explained it was a lot worse in the beginning. She then had cataract surgery and when she was on medications for that, her irregular heartbeat was really bad while she was on those medications. Once she was off of those medications, it got a little bit better. she still has a feeling at times like an elephant is sitting on her chest and when she takes a deep breath, she is still having an irregular heartbeat a lot. She clarified she thought they happen a lot but the cardiologist doesn't think so. The first time she really noticed the irregular heartbeat was around 10am on a Friday. She was at the senior center playing pool. and started not feeling good. She clarifies this was on 30Apr2021, which was 9 days after the shot. On 09May2021, her heart started racing really really bad. She was really so very uncomfortable, but she knew had a doctor's appointment on 10May2021, so she didn't go to ER even though she wished she had. There were no other medications she was taking and no other medical conditions unless cataracts are considered a medical condition. She had cataract surgery on 01Jun2021. she had to start taking these drops the day before the surgery and there were 3 different medications mixed together and that's when things really started to escalate more. She explains the first ingredient is Bromfenac, the second ingredient is Moxifloxacin, and the third ingredient is Prednisol. Another thing she sees that is says is Sod Phos 0.09/0.5/1%. When probed for NDC, Lot number or expiry date, she mentions seeing: RA then there is an registration number with what she believes is a name, but she states nothing like a Lot or expiry date are on there. She did have the flu shot on 18Oct2021. She also had another test that is not an echocardiogram, where they hooked her up and put leads on her chest, but she can't think of what this test is called. She was told everything was okay with that test, too. As soon as she got the Echocardiogram done, they put a heart monitor on her for 2 solid days, starting from 1:30pm on 08Nov2021 until 1:30pm 10Nov2021. Description of Product Complaint: Caller reports she developed an irregular heartbeat after her second shot of the Pfizer COVID vaccine. She then had cataract surgery and when she was on medications for that, her irregular heartbeat was really bad while she was on those medications. The caller states she had to start taking these drops the day before the surgery and there were 3 different medications mixed together and that's when things really started to escalate more. She explains the first ingredient is Bromfenac, the second ingredient is Moxifloxacin, and the third ingredient is Prednisol. Another thing she sees that is says is Sod Phos 0.09/0.5/1%. When probed for NDC, Lot number or expiry date, she mentions seeing: RA then there is an registered number with what she believes is a name, but she states nothing like a Lot or expiry date are on there. No follow-up attempts are possible. No further information is expected.