Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Nervousness, Palpitations, Skin burning sensation, Stress
Clinical narrative: a burning sensation on her skin, up the chest close to [her] neck/sensation of her skin burning, like a really bad sunburn to the area of her chest that connects to her neck; a stomach pain; a blood pressure [that] came down; Felt something weird going on; Felt heat internally; Shaking; an elevated heartrate/156 beats per minute; getting scared; Heart palpitations; stress; EKG: abnormal, further details unknown; anxiety; disoriented; This is a spontaneous report from a contactable other healthcare professional (hcp; patient herself). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL9262, expiry date 31May2021), via an unspecified route of administration on 28Jan2021 14:00 at a single dose in the right arm (reported as right upper arm) for vaccination (covid-19 immunisation). Medical history included patient was an ongoing insulin resistant, on supplement, hair loss, with her glasses (ongoing), had a flu at some point, cholesterol (blood cholesterol abnormal), and ongoing menopausal or peri menopausal. Family medical history included diabetes, high cholesterol, and heart disease. Concomitant medications included atorvastatin calcium (LIPITOR) for cholesterol at 40mg taken daily; ubidecarenone (SOLGAR COQ-10) at 200mg taken daily on and off as supplement; and ongoing colecalciferol (VITAMIN D) as supplement which she has taken for a while and she reported this is not an issue, unrelated to events. Patient was on "Nordic Naturals Flora Probiotic Women" from Jan2020 and ongoing that it has D-Mannose (also reported as started only a few weeks ago approximately) as supplement good for UTIs and stuff like that. She was also taking "Olly Hair growth supplement" from Jan2020 and ongoing (also reported as started only a few weeks ago approximately) as it contains biotin, keratin and amla extract and patient did not know contained grapefruit, not on ingredients list-few days after started felt a little pain in arms-discovered had grapefruit, stopped. Patient was taking at 2 gummies daily and also reported as 25mg daily for hair loss. The patient previously took on her younger years, ibuprofen and acetylsalicylic acid (ASPIRIN) for fever but had drug allergy to both. Patient also had paracetamol (TYLENOL) for an unknown indication. She had the flu at some point and just to lower her fever she took either ibuprofen or Aspirin or a combination of the 2 within a span of a few hours and had a reaction; she started feeling her fingers getting swollen; lips got swollen; weird feeling in lips. She called her doctor, told him her lips were getting swollen. He basically asked a few questions and said well don't take that stuff anymore just take Tylenol. It was unknown if she was allergic to ibuprofen or Aspirin or both, so now she said allergy to Aspirin and ibuprofen. She was going to go to an allergist to run some tests and see if they can determine which products she has allergy too; and see if they can do gradual reintroduction. Prior Vaccinations (within 4 weeks), patient did not had other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient received the first dose of the COVID-19 vaccine last Thursday (28Jan2021). She listed the following reaction following the receipt of the vaccine: "an elevated heartrate (28Jan2021 at 14:03); a burning sensation on her skin, up the chest close to [her] neck (28Jan2021 at 15:00); a stomach pain (28Jan2021 at 15:00); and a blood pressure [that] came down" (28Jan2021 at 14:03).  She explained she was therefore "sent to the ER by ambulance" and was discharge to go home a "few hours" later.  She added the last time she checked the monitor, during her reaction, she saw her "resting heartrate at 156" (28Jan2021). She also mentioned she has a family history of heart disease.  She asked for the recommendations on receiving the second dose of the COVID-19 vaccine due to her reaction to the first dose. It was further reported that immediately when she was administered the vaccine injection she felt something weird going on (28Jan2021 14:03), disoriented so she sat down (28Jan2021). Within a few minutes of getting the injection she had onset of elevated heart rate, blood pressure dropped and felt heat internally (28Jan2021 14:03); she additionally mentioned that she started shaking around this time (28Jan2021 14:03), but she did not think that was related to the vaccine, just related to her adrenaline, getting scared (28Jan2021) because she could see the monitor and her heart rate going up and the people around her looking worried. The people who were monitoring her after the injection was administered called an ambulance for her which transported her to the Emergency Room of the same hospital. Her heart rate got up to 156 beats per minute (bpm). She also reported having heart palpitations with unknown onset time (28Jan2021). Within about 1-2 hours after getting the injection she had onset of stomach pain and a sensation of her skin burning, like a really bad sunburn to the area of her chest that connects to her neck; not to the neck itself, just the area around the neck where the chest meets the neck. She did not have a rash. She managed to lower her heart rate to 114 bpm after a lot of deep breathing. She was kept under observation in the Emergency Room, not admitted to the hospital; and was discharged home around 21:30 even though she still had elevated heart rate. For elevated heart rate, she did not know if what she has been experiencing was physical or related to stress (28Jan2021). She was fine. She was a little scared about taking the second dose; there were no clear answers. She was starting menopause and peri menopause so she felt fair to say that one of the changes was getting a little more anxious so she thought the anxiety and being scared on 28Jan2021 was within the normal expectations with menopause and peri menopause. There was always a question to the possibility of heart rate increase related to psychological effects, but does not think she could elevate her heart rate to 156 bpm strictly through menopause or peri menopause related anxiety. She further described that she felt something right away which was weird, because the vaccine was not something that was supposed to have any immediate affect. Patient also stated that she had basically felt like a bad sunburn with a little tingling and a bad, bad sunburn; like her t-shirt and necklace were bothering her. She still has a little bit of sunburn feeling, but better. The stomach pain onset was also reported as about 1-2 hours after vaccine administered and was bothering her pretty bad. In the emergency room they gave her something for her stomach which helped the stomach pain; it was a thick white liquid to drink that has a numbing effect but she did not remember the name of the product. On 28Jan2021, patient had an EKG as abnormal, further details unknown. She reported that what she has not on the CDC vaccine record card she has. In response to these events she called her family doctor who asked patient if she wanted an EKG done. Patient explained to her the EKG was done in the emergency room on 28Jan2021. Her last few EKGs were abnormal and she was treated with a cardiologist. As far as she knows she does not have heart disease. She was feeling ok. Emergency room staff did not tell her much about the abnormal EKG, further details unknown; but they did tell her to follow up with her Cardiologist. Her Cardiologist said they would like her to do a CAT scan at some point so she will probably do that. She mentioned separately when looking for her CDC vaccine record card that she had to get her glasses on because starting sometime last year she got to where she can't see anything without them. The patient was not hospitalized and was kept under observation in emergency room only. Patient expressed her appreciation and gratitude for Pfizer's work and efforts/services. The events were reported as non-serious. Therapeutic measures were taken as a result of an elevated heartrate which included deep breathing, stomach pain, and EKG abnormal. Patient was recovering from "a burning sensation on her skin, up the chest close to [her] neck", "an elevated heartrate/156 beats per minute", and heart palpitations. The outcome of the events, a stomach pain and a blood pressure [that] came down, felt something weird going on, disoriented, felt heat internally, shaking, getting scared, stress, anxiety and EKG as abnormal was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.