Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
Maybe she had myocarditis; fear of the vaccine; tachycardia; increased number of PCVs / PVCs got worse; increased number of PCVs / PVCs got worse; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 33-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "PVCs" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: Wasn't hospitalized; "anxiety" (unspecified if ongoing), notes: Regarding covid; "PTSD" (unspecified if ongoing), notes: Regarding covid; "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 2021 (ongoing). The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "unknown" and all described as "increased number of PCVs / PVCs got worse"; TACHYCARDIA (non-serious) with onset 2021, outcome "recovered" (2021); MYOCARDITIS (medically significant), outcome "unknown", described as "Maybe she had myocarditis"; FEAR OF INJECTION (non-serious), outcome "not recovered", described as "fear of the vaccine". The events "tachycardia", "increased number of pcvs / pvcs got worse" and "fear of the vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: 130, notes: Without doing anything, just sitting there; 138; full cardiac workup: Unknown results, notes: Prior to getting the covid 19 vaccine; Magnetic resonance imaging heart: slight weakness within one of the ventricles, notes: After the covid 19 vaccine. Therapeutic measures were not taken as a result of tachycardia. Clinical course: Patient got the Pfizer covid-19 vaccine in June or July 2021 and she believed that within 3 hours after getting the vaccine, the patient experienced tachycardia and increased number of premature ventricular contractions (PCVs). The patient was under the care of cardiologist due to having PVCs occurring and then got the vaccine. By tachycardia, she meant her heart rate was 130 without her doing anything, she was just sitting there, and the patient could not get it to go down for 9 hours. Patient's heart went up to 130 for no reason, except for the vaccine she wasn't doing anything, that would warrant a heart rate of 130. The patient called the cardiologist office to tell them what was happening to her after the vaccine, she was told that if it did not go away after 24 hours to give them a call. It went away, so she never really saw a doctor about that. During the tachycardia episode with the vaccine her PVCs got worse and her heart start racing like she was going on the brisk walk or run. She felt them more frequently, she couldn't say for certain that PVCs were from the vaccine, she was having them before, her cardiologist did not really explain it to her. Patient's physician wanted her to move forward with the vaccine and get it because she was in the high-risk group. Her asthma was flaring up so bad that was why the physician really think that she should get the vaccine. As a result, she was nervous to move forward, she didn't want that to happen again, she didn't want to feel like that again and she was scared to get the vaccine, without being in like a medical setting and being monitored afterwards, to make sure that was not happening to her. The patient had all her vaccines, it was just this one that made her pause of and she didn't know if she should get it. She never had any reaction to any vaccine before. The patient had a history of anxiety and this episode had never happened before. She just went home from getting the vaccine. She was at home for about 2 hours and she went to get a shower and as soon as she started going down the stairs her heart started racing, and then in the entire duration of the shower her heart was racing and just continued from that point until like 03:00. She got the vaccine like at 17:00 in the afternoon, it was going on for like 6 hours. Physician recommended the vaccine for her because the risk of covid severe illness was more than risk of the side effect of the vaccine. The patient got her tetanus shot, flu shot this year and pneumonia shot. She was just literally nervous about this shot, based on her personal experience. The patient stated that she never experienced myocarditis herself, if she got it she would not know. Maybe she had myocarditis when she was experiencing tachycardia but she did not go to the emergency room and they did not evaluate that. The patient quit her job due to having severe anxiety regarding covid and she had been dealing with post-traumatic stress disorder since then. The patient had been in this situation for 5 years now, 3 and a half years from the vaccine period and haven't been cured for her fear of the vaccine by any physician. About three hours after the vaccination, she reported tachycardia with increased number of PVCs. She contacted her doctor's after-hours line since her heart rate was 138. She was nervous about getting a vaccine again. Her primary doctor advised her to do so but she was calling Pfizer to check to see if she should get another vaccine. She was nervous and anxious due to her previous experience with the vaccine. She spoke to cardiologist when it happened but did not seek treatment, she was advised to wait 24 hours. She only got one dose of the Pfizer covid-19 vaccine. The tachycardia was no longer ongoing and recovered about 6 or 7 hours after it started. She had a full cardiac workup due to PVCs she was having prior to getting the covid 19 vaccine. The lot number for BNT162b2, was not provided and will be requested during follow up.
Medical History/Concurrent Conditions: Acid reflux (esophageal); Anxiety (Regarding covid); COVID-19 (Wasn't hospitalized); Post-traumatic stress disorder (Regarding covid); Premature ventricular contractions
OMEPRAZOLE
Test Name: Heart rate; Result Unstructured Data: Test Result:130; Comments: Without doing anything, just sitting there; Test Name: Heart rate; Result Unstructured Data: Test Result:138; Test Name: full cardiac workup; Result Unstructured Data: Test Result:Unknown results; Comments: Prior to getting the covid 19 vaccine; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:slight weakness within one of the ventricles; Comments: After the covid 19 vaccine